The appearance of a drug on this list does not mean that the FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because the FDA has identified a potential safety issue.
Biogen Idec and Elan’s multiple-sclerosis treatment Tysabri, Purdue Pharma’s painkiller Oxycontin, Eli Lilly & Co’s antidepressant Cymbalta are some of the drugs included in the FDA’s quarterly list (January 2008 to March 2008).
Drugs that appear on the agency’s new Adverse Event Reporting System (AERS)-based table are identified by FDA reviewers based on reports from the FDA’s AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, healthcare professionals and patients. The drugs for which issues have been identified are under evaluation for the listed potential 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.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said: “Patients and healthcare professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues.”