Reporting on Adverse Clinical Events
November 2015
in “
Clin-Alert
”
Studysummary Some medications and supplements can cause serious side effects, including hair loss, heart rhythm problems, liver injury, and other health issues. Our plain-language summary of this paper — not a Tressless recommendation.
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.