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OFF-X COVID-19 REPORT:

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The COVID-19 outbreak is posing a tremendous challenge for the global biomedical community to find potential treatments, vaccination strategies and supportive medications. To complement the efforts being made in developing the most appropriate efficacy-oriented projects, Bioinfogate is providing, on a complimentary basis, all the relevant safety and toxicity information detected by our editorial team.

This report provides a compilation of safety alerts derived from recent publications related to COVID-19 as well as previous OFF-X content that may be of interest. Content can be sorted by target or by drug of interest. Click on any alert to jump to OFF-X and retrieve the full alert details.

Access to the COVID-19 report is granted under the following Terms & Conditions

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OFF-X COVID-19 REPORT
5-HT2A receptor
5-LOX
50S ribosomal protein
May 27, 2020
Review of clinical trials of potential treatments for COVID-19. Side effects of chloroquine, azithromycin, lopinavir/ritonavir and tocilizumab are listed. [Journal]
May 27, 2020
Study of hydroxychloroquine and azithromycin, as monotherapies or in combination, in patients with COVID-19 in New York State. Cardiac arrest and abnormal electrocardiogram findings were more common in the hydroxychloroquine + azithromycin group (15.5% and 27.1%, respectively) and hydroxychloroquine alone group (13.7% and 27.3) than in the azithromycin alone group (6.2% and 16.1%) or in patients not treated with either drug (6.8% and 14.0%). Other side effects are listed. [Journal]
May 27, 2020
Swissmedic, together with Sanofi and Helvepharm, have issued a Direct Healthcare Professional Communication warning about the risk of QT prolongation and subsequent arrhythmias (such as torsades de pointes) associated with hydroxychloroquine (TLR7/9 antagonist). The risk of QT prolongation and other hydroxychloroquine-related serious and life-threatening adverse events (including torsade de pointes, syncope, cardiac arrest and sudden death) was increased in patients receiving hydroxychloroquine combined with other drugs known to prolong QT interval, such as azithromycin. Therefore, doctors must be cautious when using hydroxychloroquine to treat Covid-19. [Regulatory Agency Communication]
May 26, 2020
Analysis of VigiBase assessing the risk of cardiovascular adverse drug reactions of proposed treatments for COVID-19 (hydroxychloroquine and azithromycin). QT prolongation and/or ventricular tachycardia including Torsades-de-Pointes were more frequently reported with each drug than with any other drug in the database (IC025 = 1.04 for hydroxychloroquine; 1.67 for azithromycin). Hydroxychloroquine was also associated with conduction disorders (1.04; including atrioventricular and bundle branch blocks) and heart failure (0.06; including fatal cases). QT prolongation and/or ventricular tachycardia including Torsades-de-Pointes were reported significantly more frequently with the combination of both drugs than with either monotherapy (ROR = 2.48 [1.28-4.79]). Whilst lethal cases of ventricular tachycardia and Torsades-de-Pointes were seen with both drugs, lethal cases of prolonged QT were only seen with azithromycin. [Journal]
May 19, 2020
Review of the cutaneous adverse events associated with potential treatments for COVID-19. Dermatological side effects are listed. [Journal]
May 08, 2020
Case series of 490 patients confirmed or suspected to have COVID-19 who were treated with azithromycin (28%), hydroxychloroquine (10%) or a combination of both (62%). QTc prolongation rates were higher in the combination group than in the azithromycin group. 12% of patients suffered critical QTc prolongation. [Journal]
Apr 21, 2020
Review of azithromycin (50S ribosomal protein inhibitor) and its application for COVID-19. Side effects of azithromycin used as monotherapy or in combination with chloroquine are listed. [Journal]
Apr 10, 2020
Review of the safety considerations regarding the use of chloroquine, hydroxychloroquine and azithromycin for SARS-CoV2 infection. Common adverse events (AEs) of chloroquine and hydroxychloroquine include pruritus, nausea and headache. Both drugs have been linked with life-threatening arrhythmias, serious hypoglycemia, hypersensitivity reactions and serious cutaneous toxicities, and are extremely toxic in overdose. Other AEs are listed. [Journal]
ACE
May 27, 2020
The AEMPS is reporting that no unfavorable effect of ACE inhibitors and AT1/AT2 receptor antagonists was seen in patients with COVID-19. No differences were seen in hospitalizations or risk of infection among subjects taking ACE inhibitors and AT1/AT2 receptor antagonists with respect to subjects on other antihypertensives. [Regulatory Agency Communication]
May 06, 2020
Retrospective study of 1,178 patients hospitalized with COVID-19. No evidence of a higher severity or mortality risk was found in patients taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. [Journal]
Apr 23, 2020
Review discussing the role of the renin-angiotensin-aldosterone system in Covid-19. Preclinical studies suggested that ACE inhibitors and AT1/2 receptor antagonists can increase ACE2 expression, which may increase susceptibility to SARS-CoV-2 infection. There is insufficient data to evaluate whether these observations can be translated to humans. [Journal]
Mar 30, 2020
The EMA is currently evaluating the potential association between the use of ACE inhibitors and angiotensin receptor blockers (ARBs) and the worsening of COVID-19. These drugs can increase the expression of ACE2, which is the entry point of the virus to human cells. Currently, there is no clinical or epidemiological evidence establishing a link between ACE inhibitors/ARBs and the severity of COVID-19. [Regulatory Agency Communication]
Mar 27, 2020
Article suggesting that patients with COVID-19 taking ACE inhibitors or angiotensin receptor blockers may have an increased risk of severe or fatal disease outcomes. These drugs increase the expression of ACE2 in the lungs, the receptor that serves as binding site for coronaviruses to enter the lungs. [Journal]
Mar 18, 2020
Study reporting that increased expression of ACE2 could facilitate infection with SARS-CoV-2. ACE2 can be increased by thiazolidinediones, ibuprofen, ACE inhibitors and angiotensin receptor blockers, suggesting an increased risk of Covid-19 in patients with cardiac diseases, hypertension, or diabetes taking these drugs. [Journal]
ACE2
AhR
AT1 receptor
May 27, 2020
The AEMPS is reporting that no unfavorable effect of ACE inhibitors and AT1/AT2 receptor antagonists was seen in patients with COVID-19. No differences were seen in hospitalizations or risk of infection among subjects taking ACE inhibitors and AT1/AT2 receptor antagonists with respect to subjects on other antihypertensives. [Regulatory Agency Communication]
May 06, 2020
Retrospective study of 1,178 patients hospitalized with COVID-19. No evidence of a higher severity or mortality risk was found in patients taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. [Journal]
Apr 23, 2020
Review discussing the role of the renin-angiotensin-aldosterone system in Covid-19. Preclinical studies suggested that ACE inhibitors and AT1/2 receptor antagonists can increase ACE2 expression, which may increase susceptibility to SARS-CoV-2 infection. There is insufficient data to evaluate whether these observations can be translated to humans. [Journal]
Mar 30, 2020
The EMA is currently evaluating the potential association between the use of ACE inhibitors and angiotensin receptor blockers (ARBs) and the worsening of COVID-19. These drugs can increase the expression of ACE2, which is the entry point of the virus to human cells. Currently, there is no clinical or epidemiological evidence establishing a link between ACE inhibitors/ARBs and the severity of COVID-19. [Regulatory Agency Communication]
Mar 27, 2020
Article suggesting that patients with COVID-19 taking ACE inhibitors or angiotensin receptor blockers may have an increased risk of severe or fatal disease outcomes. These drugs increase the expression of ACE2 in the lungs, the receptor that serves as binding site for coronaviruses to enter the lungs. [Journal]
Mar 18, 2020
Study reporting that increased expression of ACE2 could facilitate infection with SARS-CoV-2. ACE2 can be increased by thiazolidinediones, ibuprofen, ACE inhibitors and angiotensin receptor blockers, suggesting an increased risk of Covid-19 in patients with cardiac diseases, hypertension, or diabetes taking these drugs. [Journal]
AT2 receptor
May 27, 2020
The AEMPS is reporting that no unfavorable effect of ACE inhibitors and AT1/AT2 receptor antagonists was seen in patients with COVID-19. No differences were seen in hospitalizations or risk of infection among subjects taking ACE inhibitors and AT1/AT2 receptor antagonists with respect to subjects on other antihypertensives. [Regulatory Agency Communication]
May 06, 2020
Retrospective study of 1,178 patients hospitalized with COVID-19. No evidence of a higher severity or mortality risk was found in patients taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. [Journal]
Apr 23, 2020
Review discussing the role of the renin-angiotensin-aldosterone system in Covid-19. Preclinical studies suggested that ACE inhibitors and AT1/2 receptor antagonists can increase ACE2 expression, which may increase susceptibility to SARS-CoV-2 infection. There is insufficient data to evaluate whether these observations can be translated to humans. [Journal]
Mar 30, 2020
The EMA is currently evaluating the potential association between the use of ACE inhibitors and angiotensin receptor blockers (ARBs) and the worsening of COVID-19. These drugs can increase the expression of ACE2, which is the entry point of the virus to human cells. Currently, there is no clinical or epidemiological evidence establishing a link between ACE inhibitors/ARBs and the severity of COVID-19. [Regulatory Agency Communication]
Mar 27, 2020
Article suggesting that patients with COVID-19 taking ACE inhibitors or angiotensin receptor blockers may have an increased risk of severe or fatal disease outcomes. These drugs increase the expression of ACE2 in the lungs, the receptor that serves as binding site for coronaviruses to enter the lungs. [Journal]
Mar 18, 2020
Study reporting that increased expression of ACE2 could facilitate infection with SARS-CoV-2. ACE2 can be increased by thiazolidinediones, ibuprofen, ACE inhibitors and angiotensin receptor blockers, suggesting an increased risk of Covid-19 in patients with cardiac diseases, hypertension, or diabetes taking these drugs. [Journal]
Bcl-2
Carcinoembryonic antigen
Carcinoembryonic antigen-related cell adhesion molecule 5
CFTR
COX-1
May 27, 2020
Study of patients with inflammatory bowel disease to identify risk factors associated with severe COVID-19. A significant association was found for systemic corticosteroids (adjusted odds ratio [aOR] 6.9; 95% CI 2.3-20.5) and sulfasalazine or 5-aminosalicylate (aOR 3.1; 95% CI 1.3-7.7). TNF-alpha inhibitors were not associated with severe COVID-19 (aOR 0.9; 95% CI 0.4-2.2). [Journal]
Apr 01, 2020
Article discussing the contradictory evidence regarding the role of non-steroidal antiinflammatory drugs and corticosteroids in the treatment of COVID-19. Currently, there is no evidence for or against the use of ibuprofen for COVID-19. Corticosteroids have shown positive results in the treatment of viral infections, but prolonged administration could cause viral rebound and adverse events including acute respiratory distress syndrome. Preclinical studies in pigs suggested that prolonged administration of dexamethasone could enhance viral replication. [Journal]
Mar 23, 2020
The Australian Therapeutic Goods Administration (TGA) is monitoring the possible link between ibuprofen (COX-1/2 inhibitor) and Covid‑19 worsening. There is currently no published peer-reviewed scientific evidence to support a direct link. The TGA recommends patients to not stop taking ibuprofen without first talking to a doctor. [Regulatory Agency Communication]
Mar 23, 2020
The FDA is investigating the possible link between ibuprofen (COX-1/2 inhibitor) and Covid‑19 worsening. No scientific evidence supporting the link is available. [Regulatory Agency Communication]
Mar 18, 2020
Study reporting that increased expression of ACE2 could facilitate infection with SARS-CoV-2. ACE2 can be increased by thiazolidinediones, ibuprofen, ACE inhibitors and angiotensin receptor blockers, suggesting an increased risk of Covid-19 in patients with cardiac diseases, hypertension, or diabetes taking these drugs. [Journal]
Mar 18, 2020
The EMA is monitoring the concern about ibuprofen and Covid‑19 worsening. There is currently no scientific evidence establishing a link between ibuprofen and worsening of Covid‑19. Current advice recommends using the lowest effective dose for the shortest possible period. [Regulatory Agency Communication]
COX-2
May 27, 2020
Study of patients with inflammatory bowel disease to identify risk factors associated with severe COVID-19. A significant association was found for systemic corticosteroids (adjusted odds ratio [aOR] 6.9; 95% CI 2.3-20.5) and sulfasalazine or 5-aminosalicylate (aOR 3.1; 95% CI 1.3-7.7). TNF-alpha inhibitors were not associated with severe COVID-19 (aOR 0.9; 95% CI 0.4-2.2). [Journal]
Apr 01, 2020
Article discussing the contradictory evidence regarding the role of non-steroidal antiinflammatory drugs and corticosteroids in the treatment of COVID-19. Currently, there is no evidence for or against the use of ibuprofen for COVID-19. Corticosteroids have shown positive results in the treatment of viral infections, but prolonged administration could cause viral rebound and adverse events including acute respiratory distress syndrome. Preclinical studies in pigs suggested that prolonged administration of dexamethasone could enhance viral replication. [Journal]
Mar 23, 2020
The Australian Therapeutic Goods Administration (TGA) is monitoring the possible link between ibuprofen (COX-1/2 inhibitor) and Covid‑19 worsening. There is currently no published peer-reviewed scientific evidence to support a direct link. The TGA recommends patients to not stop taking ibuprofen without first talking to a doctor. [Regulatory Agency Communication]
Mar 23, 2020
The FDA is investigating the possible link between ibuprofen (COX-1/2 inhibitor) and Covid‑19 worsening. No scientific evidence supporting the link is available. [Regulatory Agency Communication]
Mar 18, 2020
Study reporting that increased expression of ACE2 could facilitate infection with SARS-CoV-2. ACE2 can be increased by thiazolidinediones, ibuprofen, ACE inhibitors and angiotensin receptor blockers, suggesting an increased risk of Covid-19 in patients with cardiac diseases, hypertension, or diabetes taking these drugs. [Journal]
Mar 18, 2020
The EMA is monitoring the concern about ibuprofen and Covid‑19 worsening. There is currently no scientific evidence establishing a link between ibuprofen and worsening of Covid‑19. Current advice recommends using the lowest effective dose for the shortest possible period. [Regulatory Agency Communication]
Cyclophilin A
D2 receptor
DNA
DNA topoisomerase 1
DNA topoisomerase 2
Dopamine receptor
Estrogen receptor
Ferriprotoporphyrin IX
May 27, 2020
Review of clinical trials of potential treatments for COVID-19. Side effects of chloroquine, azithromycin, lopinavir/ritonavir and tocilizumab are listed. [Journal]
May 27, 2020
Review on chloroquine and hydroxychloroquine for the treatment of COVID-19. In a pilot study assessing the efficacy and safety of chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor; 500 mg) in 10 in-patients with COVID-19, adverse events included vomiting, abdominal pain, nausea, diarrhea, rash/itch, cough and shortness of breath. [Journal]
May 27, 2020
The WHO has announced that it will stop a global study of hydroxychloroquine in patients with COVID-19 due to recent discouraging findings. Results from a study in 96,000 patients receiving hydroxychloroquine or chloroquine with or without an antibiotic showed a higher risk of deaths and heart problems than those who did not receive this medication. The death rate was 1/6 in patients taking hydroxychloroquine or chloroquine alone, 1/5 in patients taking chloroquine and an antibiotic, 1/4 in patients taking hydroxychloroquine and an antibiotic, and 1/11 in patients not taking any investigational drug. Serious cardiac arrythmias were increased in all treatment groups. [Website Reference]
May 26, 2020
Multinational registry analysis of 96,032 patients with COVID-19 treated with chloroquine or hydroxychloroquine, alone or in combination with a macrolide. Compared to the control group, the risk of death and de-novo ventricular arrhythmia was significantly increased in patients receiving hydroxychloroquine, hydroxychloroquine with a macrolide, chloroquine or chloroquine with a macrolide. [Journal]
May 22, 2020
Article alerting of a possible synergistic retinal toxicity in COVID-19 patients treated with combinations of drugs known to cause macular toxicity, including ritonavir, chloroquine, hydroxychloroquine and tamoxifen. Ritonavir is known to cause hypertrophy of the retinal pigmented epithelium. [Journal]
May 22, 2020
The AEMPS has warned of neuropsychiatric disorders related to chloroquine and hydroxychloroquine, including psychosis and attempted and completed suicide. A literature search found reports of other psychiatric disorders with these drugs, including agitation, insomnia, confusion, mania, hallucinations, paranoia, depression, catatonia, psychosis and suicidal ideation. These events have been observed in COVID-19 patients receiving hydroxychloroquine (800 mg first dose followed by 400 mg/day), including serious cases. A review is ongoing. [Data from an update of an AEMPS communication on possible adverse events in patients with COVID-19] [Regulatory Agency Communication]
May 20, 2020
Case report of an 84-year-old woman who developed torsade de pointes after 5 days on chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor; 500 mg twice daily) for COVID-19. [Journal]
May 18, 2020
Study of the effects of chloroquine/hydroxychloroquine with or without azithromycin on the QTc interval in 201 patients with SARS-CoV-2 infection. 7 patients (3.5%) discontinued treatment due to QTc prolongation. The maximum QTc was significantly longer in patients who received azithromycin than in those receiving chloroquine or hydroxychloroquine alone (470.4 ± 45.0 ms vs 453.3 ± 37.0 ms; p = 0.004). [Journal]
May 11, 2020
Phase IIb study of high-dose vs low-dose chloroquine for SARS-CoV-2 infection in patients taking azithromycin and ceftriaxone. 1 patient suffered severe rhabdomyolysis, which could be attributed to chloroquine or to the virus. Other adverse events included hemoglobin decrease, increased creatinine, increased creatine phosphokinase, increased creatine phosphokinase-MB and prolongation of the QTcF interval. 2 patients suffered ventricular tachycardia. [Journal]
May 11, 2020
Retrospective study of QTc prolongation in patients with COVID-19 treated with chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor). Chloroquine was linked to a mean QTc prolongation of 35 ms (95% CI 28-43 ms) using computerized interpretation and 34 ms (95% CI 25-43 ms) on manual interpretation. 23% patients had a QTc interval >500 ms during treatment. [Journal]
Apr 28, 2020
Editorial article discussing the use of chloroquine for COVID-19 infection. The adverse effects of chloroquine and hydroxychloroquine are well known and can be severe, including psychiatric effects, arrhythmia and sudden death. [Journal]
Apr 27, 2020
Health Canada has issued a communication warning against self-medication with chloroquine or hydroxychloroquine for COVID-19. These drugs can cause serious heart rhythm problems, which can be exacerbated when they are combined with azithromycin. [Regulatory Agency Communication]
Apr 27, 2020
The FDA has issued a drug safety communication warning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting and clinical trials. This warning is based on the known serious heart rhythm problems that can be caused by intake of these drugs, including QT interval prolongation, ventricular tachycardia and ventricular fibrillation (including fatal cases). Combination with azithromycin can increase the risk of heart rhythm problems. [Regulatory Agency Communication]
Apr 24, 2020
The EMA has issued a communication reminding the risk of serious side effects associated with chloroquine and hydroxychloroquine, as their use may be increased due to its potential efficacy for Covid-19. Both drugs can cause serious or fatal heart rhythm problems (including QT prolongation), which may be exacerbated at high doses or when combined with azithromycin. Other adverse events of chloroquine and hydroxychloroquine include liver and kidney problems, nerve cell damage leading to seizures and hypoglycemia. [Regulatory Agency Communication]
Apr 23, 2020
In vitro and in vivo data assessing the efficacy and safety of hydroxychloroquine (TLR7/9 antagonist) for treating COVID-19. Adverse events associated with hydroxychloroquine included QTc prolongation (by hERG blockage), retinopathy and gastrointestinal toxicity. Chloroquine was used as a model to predict the risk of QT prolongation. [Journal]
Apr 22, 2020
The NIH recommends monitoring the QTc interval in patients with COVID-19 treated with chloroquine or hydroxychloroquine. Hydroxychloroquine is better tolerated but both drugs have a similar safety profile, including QTc prolongation, torsade de pointes, ventricular arrhythmia, cardiac death, hypoglycemia, rash, nausea, retinopathy and bone marrow suppression. Other safety considerations and adverse events observed in clinical trials of COVID-19 are listed. [Data from the NIH COVID-19 Treatment Guidelines] [Website Reference]
Apr 15, 2020
Article discussing the use of chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor) as a prophylactic agent against COVID-19. High dosage chloroquine may have severe side effects including cardiac toxicity. The most frequent side effects with chloroquine/proguanil are epigastralgia, diarrhea and nausea. [Journal]
Apr 14, 2020
Phase IIb clinical study of chloroquine diphosphate (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor; 600 mg twice daily for 10 days or 450 mg twice the first day, once daily for 4 days) in 81 patients with severe respiratory syndrome due to SARS-CoV-2 infection. Adverse events were decreased hemoglobin (7/20 patients [35%]), increased creatinine (13/18 [72.2%]), prolonged QTc (10/56 [17.9%]), ventricular tachycardia (2/56 [3.5%]) and severe rhabdomyolysis (1 case). [Journal]
Apr 10, 2020
Review of the safety considerations regarding the use of chloroquine, hydroxychloroquine and azithromycin for SARS-CoV2 infection. Common adverse events (AEs) of chloroquine and hydroxychloroquine include pruritus, nausea and headache. Both drugs have been linked with life-threatening arrhythmias, serious hypoglycemia, hypersensitivity reactions and serious cutaneous toxicities, and are extremely toxic in overdose. Other AEs are listed. [Journal]
Apr 06, 2020
Study comparing chloroquine with lopinavir/ritonavir for treating COVID-19. Adverse events (AEs) with chloroquine included vomiting, diarrhea (5/10 patients [50%] each) and nausea (4/10 [40%]). With lopinavir/ritonavir, AEs included diarrhea (8/12 [66.67%]), cough (6/12 [50%]) and nausea (5/12 [41.67%]). Other AEs are listed. [Journal]
Mar 30, 2020
Review of the literature regarding chloroquine and hydroxychloroquine for the treatment of COVID-19. Both drugs have shown potential to prolong the QTc interval, a risk that is increased when azithromycin is added to hydroxychloroquine. Concurrent use of chloroquine/hydroxychloroquine and lopinavir/ritonavir can increase the risk of hypoglycemia. There have been reports of cardiomyopathy and reversible heart failure in patients treated with chloroquine. [Journal]
Mar 28, 2020
Article discussing possible harmful effects of chloroquine/hydroxychloroquine for COVID-19. In nonhuman primate models, chloroquine enhanced Chikungunya virus infection, while in a clinical study it increased the risk of chronic complications of Chikungunya virus infection. [Journal]
Mar 26, 2020
Article discussing the importance of QTc monitoring during treatment for COVID-19. Some drugs being tested for COVID-19, such as chloroquine, hydroxychloroquine, lopinavir and ritonavir, carry a known risk for drug-induced ventricular arrhythmias and sudden cardiac death. Hydroxychloroquine has the potential to cause prolongation of the QT interval. [Website Reference]
Mar 17, 2020
Systematic review of chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor) for the treatment of patients infected with COVID-19. Patients administered chloroquine should be monitored for the development of anemia, thrombocytopenia, leukopenia, electrolyte disturbances, hepatic/renal dysfunction, QT interval prolongation, bradycardia and visual/mental impairment. [Journal]
Glucocorticoid receptor
HCV NS5A protein
HIV protease
IMPDH
Interferon alpha/beta receptor
Interleukin 1 receptor, type I
Interleukin-6 receptor, alpha subunit
May 27, 2020
Review of clinical trials of potential treatments for COVID-19. Side effects of chloroquine, azithromycin, lopinavir/ritonavir and tocilizumab are listed. [Journal]
May 26, 2020
Article stating that clinicians using tocilizumab (interleukin-6 receptor, alpha subunit antagonist) to treat COVID-19 should be aware of the risk of intestinal perforation. [Journal]
May 25, 2020
Study of tocilizumab (interleukin-6 receptor, alpha subunit antagonist) in 100 patients with COVID-19. 3 patients had severe adverse events: 2 developed septic shock resulting in death, while 1 had a gastrointestinal perforation requiring surgery. [Journal]
May 25, 2020
Study reporting that the use of tocilizumab (interleukin-6 receptor, alpha subunit antagonist) in patients with COVID-19 could increase the risk of candidemia. 3 cases of candidemia were reported in 43 patients treated with tocilizumab for severe COVID-19 pneumonia, including 1 with endophthalmitis and endocarditis. [Journal]
May 21, 2020
Case report of a COVID‐19 patient who developed toxic erythema and eosinophilia due to tocilizumab (interleukin-6 receptor, alpha subunit antagonist). [Journal]
May 19, 2020
Review of the cutaneous adverse events associated with potential treatments for COVID-19. Dermatological side effects are listed. [Journal]
May 13, 2020
Case reports of 2 patients with COVID-19 treated with tocilizumab (interleukin-6 receptor, alpha subunit antagonist). 1 patient developed viral myocarditis, which may have been promoted by tocilizumab. [Journal]
May 12, 2020
Retrospective review of tocilizumab (interleukin-6 receptor, alpha subunit antagonist) in 25 Covid-19 patients. The most common adverse events (AEs) were anemia (16 any grade; 6 grade 3), increased alanine aminotransferase (11; 3), QT interval prolongation (5; 5) and increased aspartate aminotransferase (3; 0). 8 patients had Candida in their respiratory cultures. Other AEs of tocilizumab and of the concomitant agents used are listed. [Journal]
Mar 31, 2020
Article describing a potential risk of osteonecrosis of the jaw with tocilizumab (interleukin-6 receptor antagonist), a drug that is being investigated for the treatment of COVID-19. Other medications linked to this adverse event include tyrosine kinase inhibitors, monoclonal antibodies, mTOR inhibitors, radiopharmaceuticals, estrogen receptor modulators and immunosuppressants. [Journal]
JAK
JAK1
JAK2
Kv11.1
mTOR
Neuraminidase (viral)
Opioid delta receptor
Opioid kappa receptor
Opioid mu receptor
Opioid receptor
PPARgamma
Protease
Pyruvate synthase (protozoan)
Reverse transcriptase/ribonuclease H
RNA polymerase (viral)
Jun 02, 2020
Phase III study of remdesivir (viral RNA polymerase inhibitor) in patients with COVID-19 pneumonia. The most common adverse events (>5%) were nausea, diarrhea and headache. [Data from a Gilead communication announcing phase III results of remdesivir for COVID-19 infection] [Company Communication]
May 29, 2020
Review of antivirals being investigated for COVID-19. In a trial of remdesivir, adverse events (AEs) included increased hepatic transaminases (23%), diarrhea (9%), rash, renal impairment and hypotension (8% each). AEs of Kaletra (lopinavir/ritonavir) included QTc prolongation, weight gain, fat redistribution, hepatotoxicity, increased cholesterol, hyperglycemia, pancreatitis, skin rash and gastrointestinal disorders. Oseltamivir has been associated with vomiting, nausea and headache. [Journal]
May 28, 2020
Phase III clinical trial of remdesivir (viral RNA polymerase inhibitor; 100 mg/day) in patients with severe Covid-19. Common adverse events (AEs) included nausea (20/200 patients [10%] in the 5-day group; 17/197 [9%] in the 10-day group), acute respiratory failure (12 [6%]; 21 [11%]), increased ALT (11 [6%]; 15 [8%]), constipation (13 [6%]; 13 [7%]), increased AST (10 [5%]; 13 [7%]), hypokalemia (10 [5%]; 12 [6%]) and insomnia (10 [5%]; 11 [6%]). Other AEs are listed. [Journal]
May 27, 2020
Adverse reactions reported in clinical trials with remdesivir were hepatic adverse reactions, including transaminase elevations (ALT and AST) in healthy volunteers, and liver function test abnormalities in patients with COVID-19 (including transaminase elevations, serious liver-related laboratory abnormality and one case of serious blood bilirubin increased). [Data from MHRA Early Access to Medicines Scheme Information for Healthcare Professionals for remdesivir (RNA polymerase (viral) inhibitor)] [Regulatory Agency Communication]
May 27, 2020
The special warnings and precautions for use section of the MHRA Early Access to Medicines Scheme (EAMS) information for remdesivir indicates that transaminase elevations were observed in clinical studies in both healthy volunteers and patients with COVID-19. [Data from MHRA Early Access to Medicines Scheme Information for Healthcare Professionals for remdesivir (RNA polymerase (viral) inhibitor)] [Regulatory Agency Communication]
May 25, 2020
Preliminary results from a clinical study evaluating the safety and efficacy of intravenous remdesivir (viral RNA polymerase inhibitor) in patients with Covid-19. Adverse events occurring more frequently than with placebo included pyrexia (27/541 patients [5%] with remdesivir vs 17/522 [3.3%] with placebo), decreased glomerular filtration rate (20 [3.7%] vs 17 [3.3%]), increased blood glucose (12 [2.2%] vs 6 [1.1%]), hypotension (12 [2.2%] vs 7 [1.3%]), hypertension (11 [2%] vs 4 [0.8%]), pneumonia (8 [1.5%] vs 2 [0.4%]), increased creatinine (8 [1.5%] vs 4 [0.8%]), prolonged prothrombin time (7 [1.3%] vs 3 [0.6%]), decreased blood albumin, dyspnea (6 [1.1%] vs 3 [0.6%] each) and alkalosis (4 [0.7%] vs 2 [0.4%]). [Journal]
May 19, 2020
Review of the cutaneous adverse events associated with potential treatments for COVID-19. Dermatological side effects are listed. [Journal]
May 11, 2020
Side effects reported in clinical studies of Veklury in healthy subjects or patients with SARS-CoV-2 infection are listed. [Data from PMDA package insert (emergency approval) for Veklury (remdesivir; viral RNA polymerase inhibitor)] [Regulatory Agency Communication]
May 05, 2020
Phase III clinical trial of remdesivir (viral RNA polymerase inhibitor) in 237 patients with severe COVID-19. Adverse events (AEs; ≥2% and higher than with placebo) included rash (11/155 [7%] with remdesivir vs 2/78 [3%] with placebo), thrombocytopenia (16 [10%] vs 5 [6%]), increased total bilirubin (15 [10%] vs 7 [9%]), increased neutrophil (10 [6%] vs 4 [5%]), nausea (8 [5%] vs 2 [3%]) and increased serum potassium (4 [3%] vs 1 [1%]). Serious AEs included respiratory failure or acute respiratory distress syndrome (16 [10%] vs 6 [8%]), cardiac arrest, thrombocytopenia, hemorrhage of lower digestive tract and acute kidney injury (1 [1%] vs 0 each). AEs leading to drug discontinuation are listed. [Journal]
May 04, 2020
Study of remdesivir (viral RNA polymerase inhibitor) in patients with severe COVID-19. Side effects occurred in 32/53 patients (60%), most commonly increased liver enzymes, diarrhea, rash, renal dysfunction and hypotension. [Journal]
May 04, 2020
The FDA has issued an emergency use authorization for remdesivir (viral RNA polymerase inhibitor) for the treatment of suspected or laboratory-confirmed COVID-19. Possible adverse events of remdesivir include increased levels of liver enzymes (which may be a sign of inflammation or damage to liver cells) and infusion-related reactions, including low blood pressure, nausea, vomiting, sweating and shivering. [Regulatory Agency Communication]
Apr 30, 2020
Phase III trial of remdesivir (viral RNA polymerase inhibitor) for severe COVID-19. The most common adverse events (>10% patient in 1 of the groups) were nausea (5-day group: 10.0%; 10-day: 8.6%) and acute respiratory failure (5-day: 6.0%; 10-day: 10.7%). Grade ≥3 ALT elevations occurred in 28/385 patients (7.3%). 12/397 patients (3.0%) discontinued treatment due to elevated liver tests. [Company Communication]
Apr 22, 2020
Remdesivir (viral RNA polymerase inhibitor) can cause gastrointestinal symptoms (including nausea and vomiting), increased transaminases and elevation of the prothrombin time. [Data from the NIH COVID-19 Treatment Guidelines] [Website Reference]
Apr 15, 2020
Study of remdesivir (viral RNA polymerase inhibitor) in 53 patients with severe Covid-19. The most common adverse events (AEs) were increased hepatic enzymes (12 patients [23%]), diarrhea (5 [9%]), rash, renal impairment and hypotension (4 [8%] each). Serious AEs included multiple organ dysfunction syndrome, septic shock, acute kidney injury and hypotension (2 [4%] each). 4 patients discontinued remdesivir due to elevated aminotransferases (2), worsening of preexisting renal failure and multiple organ failure (1 each). Other AEs are listed. [Journal]
Apr 07, 2020
Hepatotoxicity is an identified risk of remdesivir (viral RNA polymerase inhibitor). [Data from the conditions of use of remdesivir in compassionate use for Covid-19] [Regulatory Agency Communication]
Apr 07, 2020
Pooled data of 4 phase I trials of remdesivir (viral RNA polymerase inhibitor) in 138 healthy subjects. Adverse events (AEs) reported in ≥5 subjects included phlebitis (8), constipation (7), headache (6), ecchymosis, nausea and pain in extremity (5 each). Elevations in AST/ALT levels were also observed. A serious AE of hypotension leading to fatal cardiac arrest was considered related to remdesivir. [Data from an EMA summary on compassionate use of remdesivir in patients with Covid-19] [Regulatory Agency Communication]
Apr 07, 2020
The special warnings and precautions for use section of remdesivir (viral RNA polymerase inhibitor) indicates that it may cause elevations in AST/ALT levels and prolong prothrombin time. Kidney injury and dysfunction were observed in preclinical studies. [Data from the conditions of use of remdesivir in compassionate use for Covid-19] [Regulatory Agency Communication]
Mar 26, 2020
Randomized clinical trial comparing the efficacy and safety of favipiravir (viral RNA polymerase inhibitor) and Arbidol (umifenovir) in 236 patients with COVID-19. Antiviral-associated adverse events were digestive tract reactions (including nausea and flatulence; 16/116 [13.8%] with favipiravir vs 14/120 [11.7%] with Arbidol), raised serum uric acid (16 [13.8%] vs 3 [2.5%]), abnormal liver function tests (increased ALT and/or AST; 9 [7.8%] vs 12 [10%]) and psychiatric symptom reactions (2 [1.7%] vs 1 [0.8%]). [Journal]
Mar 24, 2020
Clinical study comparing favipiravir (viral RNA polymerase inhibitor) to lopinavir plus ritonavir for the treatment of COVID-19. Adverse reactions in the favipiravir group were diarrhea (2/35) and liver and kidney injury (1/35). In the lopinavir/ritonavir group, adverse reactions included nausea (6/45), diarrhea, vomiting (5/45 each), rash (4/45), liver and kidney injury (3/45) and chest tightness and palpitations (1/45 each). [Journal]
Mar 16, 2020
Description of the first 12 patients with Covid-19 in the U.S. 3 patients received remdesivir (viral RNA polymerase inhibitor) for 4-10 days; all experienced increases in aminotransferase levels and gastrointestinal symptoms, including nausea, vomiting, gastroparesis and rectal bleeding. [Journal]
Mar 16, 2020
Remdesivir (viral RNA polymerase inhibitor) is being evaluated for the treatment of Covid-19. In phase I clinical studies of the drug for treating Ebola, remdesivir caused transient low-grade elevations in liver transaminases, the clinical significance of which is unknown. [Website Reference]
S1P receptor
S1P1 receptor
S1P5 receptor
SARS-CoV-2 proteins-directed
Serine protease
Spike glycoprotein
Steroid 5-alpha-reductase
Steroid 5-alpha-reductase 1
Steroid 5-alpha-reductase 2
Thiamine transporter 2
May 27, 2020
Review of clinical trials of potential treatments for COVID-19. Side effects of chloroquine, azithromycin, lopinavir/ritonavir and tocilizumab are listed. [Journal]
May 27, 2020
Review on chloroquine and hydroxychloroquine for the treatment of COVID-19. In a pilot study assessing the efficacy and safety of chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor; 500 mg) in 10 in-patients with COVID-19, adverse events included vomiting, abdominal pain, nausea, diarrhea, rash/itch, cough and shortness of breath. [Journal]
May 27, 2020
The WHO has announced that it will stop a global study of hydroxychloroquine in patients with COVID-19 due to recent discouraging findings. Results from a study in 96,000 patients receiving hydroxychloroquine or chloroquine with or without an antibiotic showed a higher risk of deaths and heart problems than those who did not receive this medication. The death rate was 1/6 in patients taking hydroxychloroquine or chloroquine alone, 1/5 in patients taking chloroquine and an antibiotic, 1/4 in patients taking hydroxychloroquine and an antibiotic, and 1/11 in patients not taking any investigational drug. Serious cardiac arrythmias were increased in all treatment groups. [Website Reference]
May 26, 2020
Multinational registry analysis of 96,032 patients with COVID-19 treated with chloroquine or hydroxychloroquine, alone or in combination with a macrolide. Compared to the control group, the risk of death and de-novo ventricular arrhythmia was significantly increased in patients receiving hydroxychloroquine, hydroxychloroquine with a macrolide, chloroquine or chloroquine with a macrolide. [Journal]
May 22, 2020
Article alerting of a possible synergistic retinal toxicity in COVID-19 patients treated with combinations of drugs known to cause macular toxicity, including ritonavir, chloroquine, hydroxychloroquine and tamoxifen. Ritonavir is known to cause hypertrophy of the retinal pigmented epithelium. [Journal]
May 22, 2020
The AEMPS has warned of neuropsychiatric disorders related to chloroquine and hydroxychloroquine, including psychosis and attempted and completed suicide. A literature search found reports of other psychiatric disorders with these drugs, including agitation, insomnia, confusion, mania, hallucinations, paranoia, depression, catatonia, psychosis and suicidal ideation. These events have been observed in COVID-19 patients receiving hydroxychloroquine (800 mg first dose followed by 400 mg/day), including serious cases. A review is ongoing. [Data from an update of an AEMPS communication on possible adverse events in patients with COVID-19] [Regulatory Agency Communication]
May 20, 2020
Case report of an 84-year-old woman who developed torsade de pointes after 5 days on chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor; 500 mg twice daily) for COVID-19. [Journal]
May 18, 2020
Study of the effects of chloroquine/hydroxychloroquine with or without azithromycin on the QTc interval in 201 patients with SARS-CoV-2 infection. 7 patients (3.5%) discontinued treatment due to QTc prolongation. The maximum QTc was significantly longer in patients who received azithromycin than in those receiving chloroquine or hydroxychloroquine alone (470.4 ± 45.0 ms vs 453.3 ± 37.0 ms; p = 0.004). [Journal]
May 11, 2020
Phase IIb study of high-dose vs low-dose chloroquine for SARS-CoV-2 infection in patients taking azithromycin and ceftriaxone. 1 patient suffered severe rhabdomyolysis, which could be attributed to chloroquine or to the virus. Other adverse events included hemoglobin decrease, increased creatinine, increased creatine phosphokinase, increased creatine phosphokinase-MB and prolongation of the QTcF interval. 2 patients suffered ventricular tachycardia. [Journal]
May 11, 2020
Retrospective study of QTc prolongation in patients with COVID-19 treated with chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor). Chloroquine was linked to a mean QTc prolongation of 35 ms (95% CI 28-43 ms) using computerized interpretation and 34 ms (95% CI 25-43 ms) on manual interpretation. 23% patients had a QTc interval >500 ms during treatment. [Journal]
Apr 28, 2020
Editorial article discussing the use of chloroquine for COVID-19 infection. The adverse effects of chloroquine and hydroxychloroquine are well known and can be severe, including psychiatric effects, arrhythmia and sudden death. [Journal]
Apr 27, 2020
Health Canada has issued a communication warning against self-medication with chloroquine or hydroxychloroquine for COVID-19. These drugs can cause serious heart rhythm problems, which can be exacerbated when they are combined with azithromycin. [Regulatory Agency Communication]
Apr 27, 2020
The FDA has issued a drug safety communication warning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting and clinical trials. This warning is based on the known serious heart rhythm problems that can be caused by intake of these drugs, including QT interval prolongation, ventricular tachycardia and ventricular fibrillation (including fatal cases). Combination with azithromycin can increase the risk of heart rhythm problems. [Regulatory Agency Communication]
Apr 24, 2020
The EMA has issued a communication reminding the risk of serious side effects associated with chloroquine and hydroxychloroquine, as their use may be increased due to its potential efficacy for Covid-19. Both drugs can cause serious or fatal heart rhythm problems (including QT prolongation), which may be exacerbated at high doses or when combined with azithromycin. Other adverse events of chloroquine and hydroxychloroquine include liver and kidney problems, nerve cell damage leading to seizures and hypoglycemia. [Regulatory Agency Communication]
Apr 23, 2020
In vitro and in vivo data assessing the efficacy and safety of hydroxychloroquine (TLR7/9 antagonist) for treating COVID-19. Adverse events associated with hydroxychloroquine included QTc prolongation (by hERG blockage), retinopathy and gastrointestinal toxicity. Chloroquine was used as a model to predict the risk of QT prolongation. [Journal]
Apr 22, 2020
The NIH recommends monitoring the QTc interval in patients with COVID-19 treated with chloroquine or hydroxychloroquine. Hydroxychloroquine is better tolerated but both drugs have a similar safety profile, including QTc prolongation, torsade de pointes, ventricular arrhythmia, cardiac death, hypoglycemia, rash, nausea, retinopathy and bone marrow suppression. Other safety considerations and adverse events observed in clinical trials of COVID-19 are listed. [Data from the NIH COVID-19 Treatment Guidelines] [Website Reference]
Apr 15, 2020
Article discussing the use of chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor) as a prophylactic agent against COVID-19. High dosage chloroquine may have severe side effects including cardiac toxicity. The most frequent side effects with chloroquine/proguanil are epigastralgia, diarrhea and nausea. [Journal]
Apr 14, 2020
Phase IIb clinical study of chloroquine diphosphate (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor; 600 mg twice daily for 10 days or 450 mg twice the first day, once daily for 4 days) in 81 patients with severe respiratory syndrome due to SARS-CoV-2 infection. Adverse events were decreased hemoglobin (7/20 patients [35%]), increased creatinine (13/18 [72.2%]), prolonged QTc (10/56 [17.9%]), ventricular tachycardia (2/56 [3.5%]) and severe rhabdomyolysis (1 case). [Journal]
Apr 10, 2020
Review of the safety considerations regarding the use of chloroquine, hydroxychloroquine and azithromycin for SARS-CoV2 infection. Common adverse events (AEs) of chloroquine and hydroxychloroquine include pruritus, nausea and headache. Both drugs have been linked with life-threatening arrhythmias, serious hypoglycemia, hypersensitivity reactions and serious cutaneous toxicities, and are extremely toxic in overdose. Other AEs are listed. [Journal]
Apr 06, 2020
Study comparing chloroquine with lopinavir/ritonavir for treating COVID-19. Adverse events (AEs) with chloroquine included vomiting, diarrhea (5/10 patients [50%] each) and nausea (4/10 [40%]). With lopinavir/ritonavir, AEs included diarrhea (8/12 [66.67%]), cough (6/12 [50%]) and nausea (5/12 [41.67%]). Other AEs are listed. [Journal]
Mar 30, 2020
Review of the literature regarding chloroquine and hydroxychloroquine for the treatment of COVID-19. Both drugs have shown potential to prolong the QTc interval, a risk that is increased when azithromycin is added to hydroxychloroquine. Concurrent use of chloroquine/hydroxychloroquine and lopinavir/ritonavir can increase the risk of hypoglycemia. There have been reports of cardiomyopathy and reversible heart failure in patients treated with chloroquine. [Journal]
Mar 28, 2020
Article discussing possible harmful effects of chloroquine/hydroxychloroquine for COVID-19. In nonhuman primate models, chloroquine enhanced Chikungunya virus infection, while in a clinical study it increased the risk of chronic complications of Chikungunya virus infection. [Journal]
Mar 26, 2020
Article discussing the importance of QTc monitoring during treatment for COVID-19. Some drugs being tested for COVID-19, such as chloroquine, hydroxychloroquine, lopinavir and ritonavir, carry a known risk for drug-induced ventricular arrhythmias and sudden cardiac death. Hydroxychloroquine has the potential to cause prolongation of the QT interval. [Website Reference]
Mar 17, 2020
Systematic review of chloroquine (ferriprotoporphyrin IX/thiamine transporter 2 inhibitor) for the treatment of patients infected with COVID-19. Patients administered chloroquine should be monitored for the development of anemia, thrombocytopenia, leukopenia, electrolyte disturbances, hepatic/renal dysfunction, QT interval prolongation, bradycardia and visual/mental impairment. [Journal]
TLR7
May 27, 2020
Study of hydroxychloroquine and azithromycin, as monotherapies or in combination, in patients with COVID-19 in New York State. Cardiac arrest and abnormal electrocardiogram findings were more common in the hydroxychloroquine + azithromycin group (15.5% and 27.1%, respectively) and hydroxychloroquine alone group (13.7% and 27.3) than in the azithromycin alone group (6.2% and 16.1%) or in patients not treated with either drug (6.8% and 14.0%). Other side effects are listed. [Journal]
May 27, 2020
Swissmedic, together with Sanofi and Helvepharm, have issued a Direct Healthcare Professional Communication warning about the risk of QT prolongation and subsequent arrhythmias (such as torsades de pointes) associated with hydroxychloroquine (TLR7/9 antagonist). The risk of QT prolongation and other hydroxychloroquine-related serious and life-threatening adverse events (including torsade de pointes, syncope, cardiac arrest and sudden death) was increased in patients receiving hydroxychloroquine combined with other drugs known to prolong QT interval, such as azithromycin. Therefore, doctors must be cautious when using hydroxychloroquine to treat Covid-19. [Regulatory Agency Communication]
May 27, 2020
The WHO has announced that it will stop a global study of hydroxychloroquine in patients with COVID-19 due to recent discouraging findings. Results from a study in 96,000 patients receiving hydroxychloroquine or chloroquine with or without an antibiotic showed a higher risk of deaths and heart problems than those who did not receive this medication. The death rate was 1/6 in patients taking hydroxychloroquine or chloroquine alone, 1/5 in patients taking chloroquine and an antibiotic, 1/4 in patients taking hydroxychloroquine and an antibiotic, and 1/11 in patients not taking any investigational drug. Serious cardiac arrythmias were increased in all treatment groups. [Website Reference]
May 26, 2020
Analysis of VigiBase assessing the risk of cardiovascular adverse drug reactions of proposed treatments for COVID-19 (hydroxychloroquine and azithromycin). QT prolongation and/or ventricular tachycardia including Torsades-de-Pointes were more frequently reported with each drug than with any other drug in the database (IC025 = 1.04 for hydroxychloroquine; 1.67 for azithromycin). Hydroxychloroquine was also associated with conduction disorders (1.04; including atrioventricular and bundle branch blocks) and heart failure (0.06; including fatal cases). QT prolongation and/or ventricular tachycardia including Torsades-de-Pointes were reported significantly more frequently with the combination of both drugs than with either monotherapy (ROR = 2.48 [1.28-4.79]). Whilst lethal cases of ventricular tachycardia and Torsades-de-Pointes were seen with both drugs, lethal cases of prolonged QT were only seen with azithromycin. [Journal]
May 26, 2020
Multinational registry analysis of 96,032 patients with COVID-19 treated with chloroquine or hydroxychloroquine, alone or in combination with a macrolide. Compared to the control group, the risk of death and de-novo ventricular arrhythmia was significantly increased in patients receiving hydroxychloroquine, hydroxychloroquine with a macrolide, chloroquine or chloroquine with a macrolide. [Journal]
May 25, 2020
Systematic review and meta-analysis of hydroxychloroquine (TRL7/TRL9 antagonist) in 2,354 patients with COVID-19. Adverse events were significantly more common with hydroxychloroquine than in the control group (OR: 4.1 [95% CI: 1.42-11.88]). 1 study reported cardiac arrest and abnormal ECG findings. [Journal]
May 22, 2020
Article alerting of a possible synergistic retinal toxicity in COVID-19 patients treated with combinations of drugs known to cause macular toxicity, including ritonavir, chloroquine, hydroxychloroquine and tamoxifen. Ritonavir is known to cause hypertrophy of the retinal pigmented epithelium. [Journal]
May 22, 2020
The AEMPS has warned of neuropsychiatric disorders related to chloroquine and hydroxychloroquine, including psychosis and attempted and completed suicide. A literature search found reports of other psychiatric disorders with these drugs, including agitation, insomnia, confusion, mania, hallucinations, paranoia, depression, catatonia, psychosis and suicidal ideation. These events have been observed in COVID-19 patients receiving hydroxychloroquine (800 mg first dose followed by 400 mg/day), including serious cases. A review is ongoing. [Data from an update of an AEMPS communication on possible adverse events in patients with COVID-19] [Regulatory Agency Communication]
May 21, 2020
Study assessing conduction abnormalities of hydroxychloroquine (HCQ; TLR7/TLR9 antagonist) as add on therapy to lopinavir/ritonavir in 11 patients with COVID-19. 3 patients (27.3%) developed prolonged QTc, including 1 with associated right bundle brunch block, 1 with bradycardia and 1 thrombocytopenia. 2 patients with pre-HCQ QTc prolongation were on lopinavir/ritonavir. [Journal]
May 18, 2020
Study of the effects of chloroquine/hydroxychloroquine with or without azithromycin on the QTc interval in 201 patients with SARS-CoV-2 infection. 7 patients (3.5%) discontinued treatment due to QTc prolongation. The maximum QTc was significantly longer in patients who received azithromycin than in those receiving chloroquine or hydroxychloroquine alone (470.4 ± 45.0 ms vs 453.3 ± 37.0 ms; p = 0.004). [Journal]
May 13, 2020
Case report of a 68-year-old Congolese man hospitalized for COVID-19. The patient had a G6PD deficiency and suffered hemolysis, which was worsened by hydroxychloroquine. [Journal]
May 12, 2020
Retrospective review of tocilizumab (interleukin-6 receptor, alpha subunit antagonist) in 25 Covid-19 patients. The most common adverse events (AEs) were anemia (16 any grade; 6 grade 3), increased alanine aminotransferase (11; 3), QT interval prolongation (5; 5) and increased aspartate aminotransferase (3; 0). 8 patients had Candida in their respiratory cultures. Other AEs of tocilizumab and of the concomitant agents used are listed. [Journal]
May 05, 2020
New Zealand’s Medsafe and Sanofi have issued a safety communication about hydroxychloroquine (TLR7/9 antagonist) for the treatment of COVID-19. Hydroxychloroquine has been associated with QT prolongation and subsequent arrhythmias (including torsade de pointes). QT prolongation can be exacerbated when hydroxychloroquine is combined with other drugs with known cardiac risks, such as azithromycin. Some cases of serious and life-threatening QT prolongation, torsade de pointes, syncope, cardiac arrest and sudden death have been reported in patients receiving concomitant treatment with hydroxychloroquine and azithromycin for COVID-19. [Regulatory Agency Communication]
May 05, 2020
Retrospective study of hydroxychloroquine (HC; TLR7/TLR9 antagonist) in patients with COVID-19. Compared to the group not treated with HC, HC-treated patients had a significantly higher risk of death from any cause (adjusted HR 2.61; 95% CI 1.10-6.17; P = 0.03). This was not observed in the group of patients treated with HC and azithromycin (adjusted HR 1.14; 95% CI 0.56-2.32; P = 0.72). [Journal]
May 04, 2020
Study analyzing the risk of QT interval prolongation in 90 patients with COVID-19 treated with hydroxychloroquine with or without azithromycin. 19% patients treated with hydroxychloroquine monotherapy and 21% treated with the combination experienced a prolongation of the QTc interval, which led to treatment discontinuation in 11 and 1 patients, respectively. Other adverse events of hydroxychloroquine included nausea, premature ventricular contractions and bundle branch block. In the combination group, 1 patient suffered torsades de pointes and ventricular arrhythmia. The change in the QTc interval was greater when hydroxychloroquine was coadministered with azithromycin than with hydroxychloroquine alone (P = 0.03). [Journal]
Apr 28, 2020
Editorial article discussing the use of chloroquine for COVID-19 infection. The adverse effects of chloroquine and hydroxychloroquine are well known and can be severe, including psychiatric effects, arrhythmia and sudden death. [Journal]
Apr 27, 2020
Health Canada has issued a communication warning against self-medication with chloroquine or hydroxychloroquine for COVID-19. These drugs can cause serious heart rhythm problems, which can be exacerbated when they are combined with azithromycin. [Regulatory Agency Communication]
Apr 27, 2020
The FDA has issued a drug safety communication warning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting and clinical trials. This warning is based on the known serious heart rhythm problems that can be caused by intake of these drugs, including QT interval prolongation, ventricular tachycardia and ventricular fibrillation (including fatal cases). Combination with azithromycin can increase the risk of heart rhythm problems. [Regulatory Agency Communication]
Apr 24, 2020
The EMA has issued a communication reminding the risk of serious side effects associated with chloroquine and hydroxychloroquine, as their use may be increased due to its potential efficacy for Covid-19. Both drugs can cause serious or fatal heart rhythm problems (including QT prolongation), which may be exacerbated at high doses or when combined with azithromycin. Other adverse events of chloroquine and hydroxychloroquine include liver and kidney problems, nerve cell damage leading to seizures and hypoglycemia. [Regulatory Agency Communication]
Apr 23, 2020
In vitro and in vivo data assessing the efficacy and safety of hydroxychloroquine (TLR7/9 antagonist) for treating COVID-19. Adverse events associated with hydroxychloroquine included QTc prolongation (by hERG blockage), retinopathy and gastrointestinal toxicity. Chloroquine was used as a model to predict the risk of QT prolongation. [Journal]
Apr 22, 2020
The NIH recommends monitoring the QTc interval in patients with COVID-19 treated with chloroquine or hydroxychloroquine. Hydroxychloroquine is better tolerated but both drugs have a similar safety profile, including QTc prolongation, torsade de pointes, ventricular arrhythmia, cardiac death, hypoglycemia, rash, nausea, retinopathy and bone marrow suppression. Other safety considerations and adverse events observed in clinical trials of COVID-19 are listed. [Data from the NIH COVID-19 Treatment Guidelines] [Website Reference]
Apr 21, 2020
Article describing the outbreak response strategy against COVID-19 in long-term care hospitals in Korea, including post-exposure prophylaxis using hydroxychloroquine (TLR7/TLR9 antagonist). 32 (15%) participants reported an adverse event, most commonly diarrhea/loose stool (9%), skin rash (4.3%), gastrointestinal upset and bradycardia (0.95% each). 2 patients discontinued hydroxychloroquine due to gastrointestinal upset, and 2 due to bradycardia. [Journal]
Apr 21, 2020
Real-world data of hydroxychloroquine (TLR7/TLR9 antagonist) in 181 patients hospitalized for COVID-19. 8/84 patients receiving hydroxychloroquine needed to discontinue the drug due to electrocardiogram changes (7 patients with QTc interval prolongation and 1 with first-degree atrioventricular block). 1 patient treated with lopinavir/ritonavir developed left bundle branch block. [Journal]
Apr 19, 2020
Systematic review and meta-analysis of hydroxychloroquine for COVID-19. Adverse events (AEs) included nausea, vomiting, diarrhea, abnormal liver function tests, rash and headache. When hydroxychloroquine was used in combination with azithromycin, AEs included QT interval prolongation, blurred vision, nausea, vomiting and diarrhea. [Journal]
Apr 16, 2020
Clinical trial of hydroxychloroquine (TLR7/9 antagonist; 800 mg daily) in COVID-19 patients. The most common adverse events (AEs) were diarrhea (7) and vomiting (2). 1 patient discontinued treatment due to blurred vision. Other AEs are listed. [Journal]
Apr 15, 2020
Clinical study evaluating the optimal dosing regimen of hydroxychloroquine (TLR7/9 antagonist) for COVID-19 patients. 2/13 patients discontinued hydroxychloroquine due to QT interval prolongation. [Journal]
Apr 15, 2020
Observational study evaluating the safety of hydroxychloroquine (TLR7/9 antagonist) in patients with rheumatoid arthritis, alone or in combination with azithromycin or amoxicillin, in light of rapid wide-spread use for COVID-19. Risk of cardiovascular mortality was increased in patients receiving hydroxychloroquine alone (calibrated hazard ratio = 1.65; 95% CI [1.12-2.44]) or combined with azithromycin (2.19 [1.22-3.94]). Hydroxychloroquine plus azithromycin was also associated with an increased risk of heart failure (1.22 [1.02-1.45]) and chest pain/angina (1.15 [1.05-1.26]). Other adverse events are listed. [Journal]
Apr 13, 2020
Article discussing research strategies for treatments for COVID-19. Hydroxychloroquine (TLR7/TLR9 antagonist), a potential candidate, has been linked to cardiac disorders. [Journal]
Apr 10, 2020
Review of the safety considerations regarding the use of chloroquine, hydroxychloroquine and azithromycin for SARS-CoV2 infection. Common adverse events (AEs) of chloroquine and hydroxychloroquine include pruritus, nausea and headache. Both drugs have been linked with life-threatening arrhythmias, serious hypoglycemia, hypersensitivity reactions and serious cutaneous toxicities, and are extremely toxic in overdose. Other AEs are listed. [Journal]
Apr 06, 2020
Randomized clinical trial of hydroxychloroquine (TLR7/TLR9 antagonist) in 62 patients with COVID-19. 2 patients reported an adverse event: rash and headache, respectively. [Journal]
Mar 30, 2020
Review of the literature regarding chloroquine and hydroxychloroquine for the treatment of COVID-19. Both drugs have shown potential to prolong the QTc interval, a risk that is increased when azithromycin is added to hydroxychloroquine. Concurrent use of chloroquine/hydroxychloroquine and lopinavir/ritonavir can increase the risk of hypoglycemia. There have been reports of cardiomyopathy and reversible heart failure in patients treated with chloroquine. [Journal]
Mar 26, 2020
Article discussing the importance of QTc monitoring during treatment for COVID-19. Some drugs being tested for COVID-19, such as chloroquine, hydroxychloroquine, lopinavir and ritonavir, carry a known risk for drug-induced ventricular arrhythmias and sudden cardiac death. Hydroxychloroquine has the potential to cause prolongation of the QT interval. [Website Reference]
Mar 25, 2020
Study of hydroxychloroquine (TLR7/TLR9 antagonist; 400 mg/day) for the treatment of Covid-19 in 30 treatment-naïve patients. 26.7% patients in the hydroxychloroquine group and 20.0% in the control group suffered diarrhea and abnormal liver function. [Journal]
TLR9
May 27, 2020
Study of hydroxychloroquine and azithromycin, as monotherapies or in combination, in patients with COVID-19 in New York State. Cardiac arrest and abnormal electrocardiogram findings were more common in the hydroxychloroquine + azithromycin group (15.5% and 27.1%, respectively) and hydroxychloroquine alone group (13.7% and 27.3) than in the azithromycin alone group (6.2% and 16.1%) or in patients not treated with either drug (6.8% and 14.0%). Other side effects are listed. [Journal]
May 27, 2020
Swissmedic, together with Sanofi and Helvepharm, have issued a Direct Healthcare Professional Communication warning about the risk of QT prolongation and subsequent arrhythmias (such as torsades de pointes) associated with hydroxychloroquine (TLR7/9 antagonist). The risk of QT prolongation and other hydroxychloroquine-related serious and life-threatening adverse events (including torsade de pointes, syncope, cardiac arrest and sudden death) was increased in patients receiving hydroxychloroquine combined with other drugs known to prolong QT interval, such as azithromycin. Therefore, doctors must be cautious when using hydroxychloroquine to treat Covid-19. [Regulatory Agency Communication]
May 27, 2020
The WHO has announced that it will stop a global study of hydroxychloroquine in patients with COVID-19 due to recent discouraging findings. Results from a study in 96,000 patients receiving hydroxychloroquine or chloroquine with or without an antibiotic showed a higher risk of deaths and heart problems than those who did not receive this medication. The death rate was 1/6 in patients taking hydroxychloroquine or chloroquine alone, 1/5 in patients taking chloroquine and an antibiotic, 1/4 in patients taking hydroxychloroquine and an antibiotic, and 1/11 in patients not taking any investigational drug. Serious cardiac arrythmias were increased in all treatment groups. [Website Reference]
May 26, 2020
Analysis of VigiBase assessing the risk of cardiovascular adverse drug reactions of proposed treatments for COVID-19 (hydroxychloroquine and azithromycin). QT prolongation and/or ventricular tachycardia including Torsades-de-Pointes were more frequently reported with each drug than with any other drug in the database (IC025 = 1.04 for hydroxychloroquine; 1.67 for azithromycin). Hydroxychloroquine was also associated with conduction disorders (1.04; including atrioventricular and bundle branch blocks) and heart failure (0.06; including fatal cases). QT prolongation and/or ventricular tachycardia including Torsades-de-Pointes were reported significantly more frequently with the combination of both drugs than with either monotherapy (ROR = 2.48 [1.28-4.79]). Whilst lethal cases of ventricular tachycardia and Torsades-de-Pointes were seen with both drugs, lethal cases of prolonged QT were only seen with azithromycin. [Journal]
May 26, 2020
Multinational registry analysis of 96,032 patients with COVID-19 treated with chloroquine or hydroxychloroquine, alone or in combination with a macrolide. Compared to the control group, the risk of death and de-novo ventricular arrhythmia was significantly increased in patients receiving hydroxychloroquine, hydroxychloroquine with a macrolide, chloroquine or chloroquine with a macrolide. [Journal]
May 25, 2020
Systematic review and meta-analysis of hydroxychloroquine (TRL7/TRL9 antagonist) in 2,354 patients with COVID-19. Adverse events were significantly more common with hydroxychloroquine than in the control group (OR: 4.1 [95% CI: 1.42-11.88]). 1 study reported cardiac arrest and abnormal ECG findings. [Journal]
May 22, 2020
Article alerting of a possible synergistic retinal toxicity in COVID-19 patients treated with combinations of drugs known to cause macular toxicity, including ritonavir, chloroquine, hydroxychloroquine and tamoxifen. Ritonavir is known to cause hypertrophy of the retinal pigmented epithelium. [Journal]
May 22, 2020
The AEMPS has warned of neuropsychiatric disorders related to chloroquine and hydroxychloroquine, including psychosis and attempted and completed suicide. A literature search found reports of other psychiatric disorders with these drugs, including agitation, insomnia, confusion, mania, hallucinations, paranoia, depression, catatonia, psychosis and suicidal ideation. These events have been observed in COVID-19 patients receiving hydroxychloroquine (800 mg first dose followed by 400 mg/day), including serious cases. A review is ongoing. [Data from an update of an AEMPS communication on possible adverse events in patients with COVID-19] [Regulatory Agency Communication]
May 21, 2020
Study assessing conduction abnormalities of hydroxychloroquine (HCQ; TLR7/TLR9 antagonist) as add on therapy to lopinavir/ritonavir in 11 patients with COVID-19. 3 patients (27.3%) developed prolonged QTc, including 1 with associated right bundle brunch block, 1 with bradycardia and 1 thrombocytopenia. 2 patients with pre-HCQ QTc prolongation were on lopinavir/ritonavir. [Journal]
May 18, 2020
Study of the effects of chloroquine/hydroxychloroquine with or without azithromycin on the QTc interval in 201 patients with SARS-CoV-2 infection. 7 patients (3.5%) discontinued treatment due to QTc prolongation. The maximum QTc was significantly longer in patients who received azithromycin than in those receiving chloroquine or hydroxychloroquine alone (470.4 ± 45.0 ms vs 453.3 ± 37.0 ms; p = 0.004). [Journal]
May 13, 2020
Case report of a 68-year-old Congolese man hospitalized for COVID-19. The patient had a G6PD deficiency and suffered hemolysis, which was worsened by hydroxychloroquine. [Journal]
May 12, 2020
Retrospective review of tocilizumab (interleukin-6 receptor, alpha subunit antagonist) in 25 Covid-19 patients. The most common adverse events (AEs) were anemia (16 any grade; 6 grade 3), increased alanine aminotransferase (11; 3), QT interval prolongation (5; 5) and increased aspartate aminotransferase (3; 0). 8 patients had Candida in their respiratory cultures. Other AEs of tocilizumab and of the concomitant agents used are listed. [Journal]
May 05, 2020
New Zealand’s Medsafe and Sanofi have issued a safety communication about hydroxychloroquine (TLR7/9 antagonist) for the treatment of COVID-19. Hydroxychloroquine has been associated with QT prolongation and subsequent arrhythmias (including torsade de pointes). QT prolongation can be exacerbated when hydroxychloroquine is combined with other drugs with known cardiac risks, such as azithromycin. Some cases of serious and life-threatening QT prolongation, torsade de pointes, syncope, cardiac arrest and sudden death have been reported in patients receiving concomitant treatment with hydroxychloroquine and azithromycin for COVID-19. [Regulatory Agency Communication]
May 05, 2020
Retrospective study of hydroxychloroquine (HC; TLR7/TLR9 antagonist) in patients with COVID-19. Compared to the group not treated with HC, HC-treated patients had a significantly higher risk of death from any cause (adjusted HR 2.61; 95% CI 1.10-6.17; P = 0.03). This was not observed in the group of patients treated with HC and azithromycin (adjusted HR 1.14; 95% CI 0.56-2.32; P = 0.72). [Journal]
May 04, 2020
Study analyzing the risk of QT interval prolongation in 90 patients with COVID-19 treated with hydroxychloroquine with or without azithromycin. 19% patients treated with hydroxychloroquine monotherapy and 21% treated with the combination experienced a prolongation of the QTc interval, which led to treatment discontinuation in 11 and 1 patients, respectively. Other adverse events of hydroxychloroquine included nausea, premature ventricular contractions and bundle branch block. In the combination group, 1 patient suffered torsades de pointes and ventricular arrhythmia. The change in the QTc interval was greater when hydroxychloroquine was coadministered with azithromycin than with hydroxychloroquine alone (P = 0.03). [Journal]
Apr 28, 2020
Editorial article discussing the use of chloroquine for COVID-19 infection. The adverse effects of chloroquine and hydroxychloroquine are well known and can be severe, including psychiatric effects, arrhythmia and sudden death. [Journal]
Apr 27, 2020
Health Canada has issued a communication warning against self-medication with chloroquine or hydroxychloroquine for COVID-19. These drugs can cause serious heart rhythm problems, which can be exacerbated when they are combined with azithromycin. [Regulatory Agency Communication]
Apr 27, 2020
The FDA has issued a drug safety communication warning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting and clinical trials. This warning is based on the known serious heart rhythm problems that can be caused by intake of these drugs, including QT interval prolongation, ventricular tachycardia and ventricular fibrillation (including fatal cases). Combination with azithromycin can increase the risk of heart rhythm problems. [Regulatory Agency Communication]
Apr 24, 2020
The EMA has issued a communication reminding the risk of serious side effects associated with chloroquine and hydroxychloroquine, as their use may be increased due to its potential efficacy for Covid-19. Both drugs can cause serious or fatal heart rhythm problems (including QT prolongation), which may be exacerbated at high doses or when combined with azithromycin. Other adverse events of chloroquine and hydroxychloroquine include liver and kidney problems, nerve cell damage leading to seizures and hypoglycemia. [Regulatory Agency Communication]
Apr 23, 2020
In vitro and in vivo data assessing the efficacy and safety of hydroxychloroquine (TLR7/9 antagonist) for treating COVID-19. Adverse events associated with hydroxychloroquine included QTc prolongation (by hERG blockage), retinopathy and gastrointestinal toxicity. Chloroquine was used as a model to predict the risk of QT prolongation. [Journal]
Apr 22, 2020
The NIH recommends monitoring the QTc interval in patients with COVID-19 treated with chloroquine or hydroxychloroquine. Hydroxychloroquine is better tolerated but both drugs have a similar safety profile, including QTc prolongation, torsade de pointes, ventricular arrhythmia, cardiac death, hypoglycemia, rash, nausea, retinopathy and bone marrow suppression. Other safety considerations and adverse events observed in clinical trials of COVID-19 are listed. [Data from the NIH COVID-19 Treatment Guidelines] [Website Reference]
Apr 21, 2020
Article describing the outbreak response strategy against COVID-19 in long-term care hospitals in Korea, including post-exposure prophylaxis using hydroxychloroquine (TLR7/TLR9 antagonist). 32 (15%) participants reported an adverse event, most commonly diarrhea/loose stool (9%), skin rash (4.3%), gastrointestinal upset and bradycardia (0.95% each). 2 patients discontinued hydroxychloroquine due to gastrointestinal upset, and 2 due to bradycardia. [Journal]
Apr 21, 2020
Real-world data of hydroxychloroquine (TLR7/TLR9 antagonist) in 181 patients hospitalized for COVID-19. 8/84 patients receiving hydroxychloroquine needed to discontinue the drug due to electrocardiogram changes (7 patients with QTc interval prolongation and 1 with first-degree atrioventricular block). 1 patient treated with lopinavir/ritonavir developed left bundle branch block. [Journal]
Apr 19, 2020
Systematic review and meta-analysis of hydroxychloroquine for COVID-19. Adverse events (AEs) included nausea, vomiting, diarrhea, abnormal liver function tests, rash and headache. When hydroxychloroquine was used in combination with azithromycin, AEs included QT interval prolongation, blurred vision, nausea, vomiting and diarrhea. [Journal]
Apr 16, 2020
Clinical trial of hydroxychloroquine (TLR7/9 antagonist; 800 mg daily) in COVID-19 patients. The most common adverse events (AEs) were diarrhea (7) and vomiting (2). 1 patient discontinued treatment due to blurred vision. Other AEs are listed. [Journal]
Apr 15, 2020
Clinical study evaluating the optimal dosing regimen of hydroxychloroquine (TLR7/9 antagonist) for COVID-19 patients. 2/13 patients discontinued hydroxychloroquine due to QT interval prolongation. [Journal]
Apr 15, 2020
Observational study evaluating the safety of hydroxychloroquine (TLR7/9 antagonist) in patients with rheumatoid arthritis, alone or in combination with azithromycin or amoxicillin, in light of rapid wide-spread use for COVID-19. Risk of cardiovascular mortality was increased in patients receiving hydroxychloroquine alone (calibrated hazard ratio = 1.65; 95% CI [1.12-2.44]) or combined with azithromycin (2.19 [1.22-3.94]). Hydroxychloroquine plus azithromycin was also associated with an increased risk of heart failure (1.22 [1.02-1.45]) and chest pain/angina (1.15 [1.05-1.26]). Other adverse events are listed. [Journal]
Apr 13, 2020
Article discussing research strategies for treatments for COVID-19. Hydroxychloroquine (TLR7/TLR9 antagonist), a potential candidate, has been linked to cardiac disorders. [Journal]
Apr 10, 2020
Review of the safety considerations regarding the use of chloroquine, hydroxychloroquine and azithromycin for SARS-CoV2 infection. Common adverse events (AEs) of chloroquine and hydroxychloroquine include pruritus, nausea and headache. Both drugs have been linked with life-threatening arrhythmias, serious hypoglycemia, hypersensitivity reactions and serious cutaneous toxicities, and are extremely toxic in overdose. Other AEs are listed. [Journal]
Apr 06, 2020
Randomized clinical trial of hydroxychloroquine (TLR7/TLR9 antagonist) in 62 patients with COVID-19. 2 patients reported an adverse event: rash and headache, respectively. [Journal]
Mar 30, 2020
Review of the literature regarding chloroquine and hydroxychloroquine for the treatment of COVID-19. Both drugs have shown potential to prolong the QTc interval, a risk that is increased when azithromycin is added to hydroxychloroquine. Concurrent use of chloroquine/hydroxychloroquine and lopinavir/ritonavir can increase the risk of hypoglycemia. There have been reports of cardiomyopathy and reversible heart failure in patients treated with chloroquine. [Journal]
Mar 26, 2020
Article discussing the importance of QTc monitoring during treatment for COVID-19. Some drugs being tested for COVID-19, such as chloroquine, hydroxychloroquine, lopinavir and ritonavir, carry a known risk for drug-induced ventricular arrhythmias and sudden cardiac death. Hydroxychloroquine has the potential to cause prolongation of the QT interval. [Website Reference]
Mar 25, 2020
Study of hydroxychloroquine (TLR7/TLR9 antagonist; 400 mg/day) for the treatment of Covid-19 in 30 treatment-naïve patients. 26.7% patients in the hydroxychloroquine group and 20.0% in the control group suffered diarrhea and abnormal liver function. [Journal]
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