Reporting on Adverse Clinical Events
November 2015
in “
Clin-Alert
”
TLDR Some medications and supplements can cause serious side effects, including hair loss, heart rhythm problems, liver injury, and other health issues.
The document from November 1, 2015, discusses various adverse clinical events linked to medications and supplements. It includes a case of a 26-year-old female who developed alopecia after taking rivaroxaban, which resolved after stopping the drug. Three cases of bradyarrhythmias were potentially associated with sofosbuvir in a group of 415 patients. The FDA recalled supplements with undeclared drugs and noted frequent emergency visits due to supplement-related adverse events. Other cases reported include nail hyperpigmentation from long-term minocycline use, eosinophilia and increased salivation from clozapine, which resolved upon discontinuation, and severe liver injury linked to hepatitis C treatments. A systematic review found a 4% frequency of serious adverse reactions, with polypharmacy as a common risk factor. A retrospective analysis identified hypokalemia and a QTc interval of ≥500 ms as risk factors for drug-induced malignant arrhythmias. The FDA stated that long-term clopidogrel use does not affect mortality and warned against herbal supplements with undeclared prescription drugs. A 58-year-old male developed tendinopathy from ofloxacin otic drops, and a study in a Jordan hospital found a 3.2% prevalence rate of ADRs, with increased risk with each additional medication. Reporting and monitoring ADRs were emphasized for safety and management.