FDA investigating 20 drugs submitted to new safety reporting system

The FDA is investigating the safety of 20 drugs based on an event reporting system for the first three months of this year. According to the FDA, the appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

According to the FDA , the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication.

The Associated Press reports that some of the drugs listed for potential safety problems were already publicized, including tumor necrosis factor blockers, which are being investigated for a potential link to cancer in children. Other drugs on the list include the anesthetic Suprane (desflurane)—which is being investigated for its potential to cause cardiac arrest—and the multiple sclerosis drug Tysabri (natalizumab), which may be linked to melanoma.

According to the FDA, a drug’s appearance on the list does not mean that the agency has concluded that the drug has the listed risk or that physicians should stop prescribing the medication; the agency adds that it will “issue additional public communications as appropriate” after completing evaluations. Should the FDA determine that a drug is associated with the listed risk, the agency may take a variety of actions including requiring labeling changes, mandating the development of a Risk Evaluation and Mitigation Strategy, or gathering more data to better characterize the risk.

(SOURCES: Advisory Board Daily Briefing , www.advisory.com, September 8, 2008; Alonso-Zaldivar, AP , 9/5; Brown, Washington Post , 9/6 [registration required]; Gever, MedPage Today , 9/5; FDA release , 9/5).