Multaq Makes Fifth Appearance on FDA Watch List

Each quarter, the U.S. Food and Drug Administration releases an updated list of drugs to watch for potential signs of serious side effects or safety issues. For the fifth consecutive time, Sanofi-Aventis’ Multaq (dronedarone) is included.

The FDA’s most recent watch list covers the first three months of 2011. During this span of time, the agency detected signs of renal impairment and failure associated with use of dronedarone. The drug, which was originally approved in July 2009, is used to reduce the risk for cardiovascular hospitalization for patients with persistent atrial fibrillation.

The FDA compiles their list of drugs to watch each quarter based on data collected through its Adverse Event Reporting System (AERS). It is important to note that just because a drug appears on the FDA watch list, it does not mean that the agency has determined it to be a health or safety risk. It does, however, mean that the FDA will study these drugs in order to determine any real causal links. If causal links are found, then the agency could decide to take regulatory action.

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