April 22, 2011 — The US Food and Drug Administration (FDA) has issued its latest list of drugs to monitor after having identified potential signs of serious risks or new safety information in the agency's Adverse Event Reporting System (AERS).
The quarterly watch list consists of 9 medications that treat conditions ranging from arthritis to schizophrenia. The agency is studying them to determine whether they are causally linked to the possible risks reported through AERS from October 1, 2010, through December 31, 2010. If a link is established, the FDA then would consider some form of regulatory action, such as revising the drug's label information, requiring a Risk Evaluation and Mitigation Strategy (REMS), or gathering more data to better characterize the risk.
The FDA cautions that a drug's appearance on the watch list does not mean the agency has determined that the drug actually poses the health risk in question. Accordingly, physicians should not stop prescribing these drugs, nor should patients stop taking them.
Since the last quarter of 2010, 1 drug on the current list — an antiarrhythmic agent called dronedarone (Multaq, Sanofi-Aventis) — has prompted increased FDA vigilance. In February, the agency alerted clinicians to cases of rare but severe liver injury, including 2 cases of acute liver failure, in patients treated with dronedarone. The agency also added information about the potential risk of liver injury to the drug's label.
Potential Signals of Serious Risks/New Safety Information Identified by AERS, October to December 2010