Articles related to PHARMACOVIGILANCE

Breckenridge Pharmaceutical initiated a voluntary Class II recall of duloxetine delayed-release capsules 60 mg (Lot 241069C, expiration May 31, 2027) on April 21, 2026, following detection of elevated N-nitroso-duloxetine impurity levels attributed to CGMP deviations at the Barcelona manufacturing site, affecting 165,761 bottles distributed nationwide.

Glucosamine use was associated with a 25% increase in mortality risk in patients with Alzheimer’s disease-related dementia in a retrospective analysis of more than 50,000 patients, with no corresponding signal observed in those with mild cognitive impairment.

A two-sample analysis of GWAS data identified genetically predicted associations between six commonly prescribed medications and increased erectile dysfunction risk, while aspirin did not reach statistical significance after SNP exclusions.

A retrospective analysis of FDA postmarketing reports identified textural changes, pigmentary alteration, and subcutaneous fat loss as the most frequently reported adverse events following radiofrequency microneedling, with most cases occurring on the face and submental area.

Eleven infants in Spain developed hypertrichosis in 2024 after secondary exposure to caregivers’ topical minoxidil, with symptoms resolving once exposure ended.

A SARS-CoV-2 variant designated BA.3.2, or “Cicada,” has been added to the WHO variants under monitoring list, with wastewater detection across at least 25 US states and 132 locations.