Cardiac adverse events associated with chloroquine and hydroxychloroquine exposure in 20 years of drug safety surveillance reports

Cohen, Isaac; Makunts, Tigran; Moumedjian, Talar; Issa, M; Abagyan, Ruben

doi:10.1038/s41598-020-76258-0

Cited by 18 publications

(13 citation statements)

References 37 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…HCQ is currently being used to treat malaria, systemic lupus erythematosus, and rheumatoid arthritis where its cardiac safety profile is substantial. 3,10 J o u r n a l P r e -p r o o f Given its prevalence, and the increased risk of DI-arrhythmias and the potential DI-SCD associated with this drug, genetic testing for p.S1103Y-SCN5A may be warranted before the initiation of HCQ and other QT-prolonging drugs in those of African descent. Importantly, a baseline 12-lead ECG alone may not be suitable for screening as p.S1103Y-SCN5A does not appear to affect the APD90 under baseline conditions.…”

Section: Discussionmentioning

confidence: 99%

Patient-specific, re-engineered cardiomyocyte model confirms the circumstance-dependent arrhythmia risk associated with the African-specific common SCN5A polymorphism p.S1103Y: Implications for the increased sudden deaths observed in black individuals during the COVID-19 pandemic

et al. 2022

View full text Add to dashboard Cite

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

show abstract

Section: Discussionmentioning

confidence: 99%

Patient-specific, re-engineered cardiomyocyte model confirms the circumstance-dependent arrhythmia risk associated with the African-specific common SCN5A polymorphism p.S1103Y: Implications for the increased sudden deaths observed in black individuals during the COVID-19 pandemic

et al. 2022

View full text Add to dashboard Cite

show abstract

“…Online databases were consulted to translate all drug names into single generic terms. Around 0.4% of all the FAERS/AERS reports were duplicates 45 – 47 . These are either repeated AEs in the same patient or multiple entrances for the same AE occurrence.…”

Section: Methodsmentioning

confidence: 99%

Myocarditis occurrence with cancer immunotherapy across indications in clinical trial and post-marketing data

Makunts

Saunders

Cohen

et al. 2021

Sci Rep

Self Cite

View full text Add to dashboard Cite

Antibodies targeting the PD-1, PD-L1, and CTLA-4 immune checkpoint axis have been used in a variety of tumor types. They achieve anti-tumor activity through activating the patient’s own immune system to target immune response evading cancer cells. However, this unique mechanism of action may cause immune-related adverse events, irAEs. One of these irAEs is myocarditis which is associated with an alarming mortality rate. In this study we presented clinical cases of myocarditis from safety trial datasets submitted to the U.S. Food and Drug Administration, FDA. Additionally, we analyzed over fourteen million FDA Adverse Event Reporting System, FAERS, submissions. The statistical analysis of the FAERS data provided evidence of significantly increased reporting of myocarditis in patients administered immune checkpoint inhibitors alone, in combination with another immune checkpoint inhibitor, the kinase inhibitor axitinib, or chemotherapy, for all cancer types, when compared to patients administered chemotherapy. All combination therapies led to further increased reporting odds ratios of myocarditis. We further analyzed the occurrence of myocarditis by stratifying the reports into sub-cohorts based on specific cancer types and treatment/control groups in major cancer immunotherapy efficacy trials and confirmed the observed trend for each cohort.

show abstract

“…Unix language/code was used for both data management restructuring, and analysis. Additionally, it was necessary to standardize all the drug names by generic terms due to the variability of brand names in the internationally submitted reports 8 , 36 , 37 .…”

Section: Methodsmentioning

confidence: 99%

Postmarketing safety surveillance data reveals protective effects of botulinum toxin injections against incident anxiety

Wollmer

Makunts

Krüger

et al. 2021

Sci Rep

Self Cite

View full text Add to dashboard Cite

Randomized controlled trials (RCTs) have shown an antidepressant effect of glabellar botulinum toxin (BoNT) injections. In the FDA Adverse Event Reporting System (FAERS) database, BoNT injection is associated with reduced incidence rates of depression across various non-psychiatric indications, which confirms the previous findings independently of specific expectations to an antidepressant effect of BoNT. The rationale of using BoNT to treat depression is to interrupt proprioceptive body feedback that may reinforce negative emotions. Negative emotions also occur in other mental disorders, suggesting a transdiagnostic therapeutic potential of BoNT in psychiatry. Here we report an analysis of the FAERS database, in which we found that, compared to alternative treatments, BoNT injections were associated with lower incidence of anxiety symptoms and related disorders. Among seven indications/injection sites, we found this protective effect of BoNT in cosmetic use/facial muscles, migraine/facial and head muscles, spasms and spasticity/upper and lower limbs, torticollis and neck pain/neck muscles, and sialorrhea/parotid and submandibular glands (reporting odds ratios 0.79–0.27). These findings are encouraging for possible future RCTs on the use of BoNT as a treatment for anxiety and related disorders.

show abstract

Cardiac adverse events associated with chloroquine and hydroxychloroquine exposure in 20 years of drug safety surveillance reports

Cited by 18 publications

References 37 publications

Patient-specific, re-engineered cardiomyocyte model confirms the circumstance-dependent arrhythmia risk associated with the African-specific common SCN5A polymorphism p.S1103Y: Implications for the increased sudden deaths observed in black individuals during the COVID-19 pandemic

Patient-specific, re-engineered cardiomyocyte model confirms the circumstance-dependent arrhythmia risk associated with the African-specific common SCN5A polymorphism p.S1103Y: Implications for the increased sudden deaths observed in black individuals during the COVID-19 pandemic

Myocarditis occurrence with cancer immunotherapy across indications in clinical trial and post-marketing data

Postmarketing safety surveillance data reveals protective effects of botulinum toxin injections against incident anxiety

Contact Info

Product

Resources

About