Actions of the National Regulatory Authorities in 10 Low- and Middle-Income Countries Following Stringent Regulatory Authority Safety Alerts on Rosiglitazone.

Abstract

On September 23, 2010, the US Food and Drug Administration and the European Medicines Agency issued safety alerts for medicines containing rosiglitazone. The authors monitored the actions of national regulatory authorities (NRAs) from 10 low- and middle-income countries to identify the time lag between the issuance of safety alerts by these two stringent regulatory authorities and any actions by these select NRAs. Two NRAs outside Africa took regulatory actions related to safety of rosiglitazone within 2 weeks of stringent regulatory authority safety alerts. For the 7 of the 8 African NRAs where the authors could confirm the date of regulatory action, the median time lag before some regulatory action was 43 days, although there was considerable variability in time to regulatory action. Low- and middle-income countries should create or strengthen systems for timely consideration and management of emerging safety issues for products that they have registered.