Avandia and Actos to Contain Black Box Warning Labels

posted on:
August 17, 2007


Health officials announced this week that the diabetes drugs Avandia and Actos will contain "black box" warnings. "Black box" warnings are the most severe warnings that a prescription drug can receive.

The new warnings will alert consumers that the drugs may cause or worsen heart problems and that patients should be carefully monitored.

The new warnings come just weeks after the Food and Drug Administration meet with experts to discuss the health risks of Avandia. One expert told the FDA that the heart attack risks associated with Avandia fail to justify the continued use of the drug. The FDA, however, has not seen enough evidence to pull the drug from shelves. Instead, Avandia and Actos labels will now include updated information about possible heart risks.

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