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Rosiglitazone (Avandia) Market Suspension – Saudi Arabia March 2010
Wallach and co-workers publishing in the February 5, 2020 British Medical Journal (BMJ 2020; 368:l7078) must be commended for the extraordinary effort in updating the cardiovascular risk of the type 2 diabetes drug rosiglitazone. The stated aim was to clarity rosiglitazone’s cardiovascular risk; the effect of different types of analyses on meta-analyses results; and to promote clinical trial transparency and data sharing.
Based on a six-month review that included free publically available US Food and Drug Administration (US FDA) new drug approval documents the Saudi Food and Drug Authority’s (SFDA) National Drug Information Service recommended that the marketing authorization for rosiglitazone be suspended in the Kingdom. This occurred in March 2010.
Wallach and co-workers point out the need for independent evidence assessment. For drugs this must include both safety and efficacy. This may be particularly true for small organizations and drug regulatory authorities with limited resources.
US FDA new drug approval documents are underutilized and should be more widely promoted to patients and professionals. These documents provide the opportunity for independent analyses of regulatory evidence meeting transparent quality standards because safety and efficacy cannot be assessed in isolation.