FDA adverse event reports on statin-associated rhabdomyolysis

This article presents the results of an exploratory studyto evaluate the strengths and limitations of using the Adverse Event Reporting System (AERS) of the Food and Drug Administration (FDA) for researching information on adverse events, using statin-associated rhabdomyolysis as an example. It should be noted that, although the FDA’s database was used for this analysis, the opinions expressed in this article are solely those of the authors and not the FDA. One of the limitations of the premarketing phase of drug development is that rare adverse events go undetected, pri-marily due to the small sample size involved, the short du-ration of the studies, and the controlled setting of the trials.1 For example, to detect an adverse event that occurs in 1 out of 1000 patients with a 95 % confidence level, 3000 patients need to receive the drug, which is approxi-mately the number of patients exposed to a drug in the pre-marketing phase. Therefore, only adverse events with a higher incidence may be detected.2 Similarly, most patients in the premarketing phase are generally exposed to a drug for a chronic condition for <1 year, unlike when the drug enters general clinical use. Thus, postmarketing surveil-lance (which begins when the drug enters the general mar-ket) of drug-related adverse events plays a valuable role in early identification and signaling of rare but serious ad-verse events associated with drug therapy. This monitoring forms the foundation for such tools as revisions in product labeling,3 “Dear Health Professional ” letters, Safety Alerts, and product withdrawals from the market. These measures are in place to promote safe drug therapy, and therefore protect the health of the public. It is important to realize