[Pharmacovigilance update]

ABSTRACT

The main pharmacovigilance updates in 2020 are reviewed. Remdesivir in COVID-19 relatively safe but turns out to be less effective than expected. Hydroxychloroquine in COVID-19  lack of efficacy and risk of arrhythmias. Cytokines storm in COVID-19 may impact pharmacokinetics. VEGF inhibitors risk of aneurysm and artery dissection. Tofacitinib dose-dependant risk of venous thromboembolic events. Ondansetron in the first trimester of pregnancy  a highly debated risk of orofacial cleft defects. Fingolimod  contraindicated during pregnancy due to suspected risk of congenital malformations. Ranitidine global market withdrawal due to contamination with nitrosamines. Ulipristal for uterine fibroids  market withdrawal due to risk of severe liver injury. Ingenol mebutate  market withdrawal due to paradoxical risk of skin cancers.