Strengthening Pharmacovigilance Reporting for Withdrawal Reactions to Support Deprescribing

Pharmacovigilance plays a crucial role in post-marketing surveillance of medicines and relies on the spontaneous reporting of adverse drug reactions (ADRs). Discontinuation of a drug can cause clinically relevant signs and symptoms, including withdrawal reactions; however, this subset of ADRs is not fully accommodated in current pharmacovigilance practice. We discuss proposed revisions to current ADR forms that could enhance the capture of withdrawal reaction evidence.