BACKGROUND: As requirements of the FDA regarding development of Risk Minimization Action Plans (RiskMAPs) and Risk Evaluation and Mitigation Strategies (REMS) have evolved, there is little information in the public domain that gives researchers or other stakeholders a concise view of the nature and characteristics of the existing programs for drugs on the market.
OBJECTIVES: To review characteristics of active REMS in the US for drugs with significant known risks.
METHODS: We identified all drugs recognized by the FDA as having an active REMS as of February 15, 2009. Authors reviewed publicly available information to identify the safety issue prompting the REMS; the original indication for the products; the nature of REMS elements, including medication guide, communication programs, elements to assure safe use; and whether the REMS was approved at the time of or following drug approval.
RESULTS: All but four REMS that were identified had a medication guide and 14 included elements to assure safe use. Among indications for the products with REMS, 9 were in the biologic or immunology category, 7 were for neurological conditions, and 4 were for cardiovascular diseases. Safety concerns prompting the REMS included mental health problems such as suicidality (n¼5), conditions with infectious origin (n¼4), birth defects (n¼4), increased CV risk (n¼3), liver toxicity (n¼3), and abuse/ diversion (n¼3). All REMS aimed at preventing birth defects or abuse/diversion included elements to assure safe use. The majority of the REMS identified were established at the time of drug approval, but 10 were initiated in response to issues identified after first approval.
CONCLUSIONS: While existing REMS are highly targeted to specific events and often limited populations, some patterns are emerging. However, details of most existing programs are not readily available. The lack of publicly available information limits the knowledge base upon which new REMS are developed.
