FDA ‘lapses' in Vioxx actions

March 2, 2005

After the Vioxx recall, the FDA was criticized for its oversight in allowing Vioxx to remain on the market as long as it had, despite the risks of heart attacks and strokes discovered. The FDA continued to maintain that it did nothing wrong, but a top agency official acknowledged there were “lapses” in the agency's actions before a Senate panel yesterday.

The deputy director of the office of new drugs, Dr. Sandra Kweder, said the agency took too long to get information regarding Vioxx heart risks into the prescribing label provided to physicians because of difficult negotiations with Vioxx maker Merck & Co. Because of the negotiations on how the specific language should be worded, the placement, etc., Kweder said it was over a year before an advisory panel's conclusion that the risks should be highlighted and label changes made went into effect.

Estimates by drug safety officials at the FDA attribute as many as 55,000 deaths from heart attacks and strokes because of Vioxx in the years after its heart risks became apparent. Kweder believes giving the FDA the power to require label changes “would be very helpful,” and most witnesses testifying before the panel agreed.

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