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FDA Opens Baycol Probe

Agency Feeling the Heat after Vioxx Withdrawal

November 29, 2004
The Food and Drug Administration (FDA) has launched a review of Bayer's August 2001 withdrawal of Baycol from the market, following reports that the drug company knew of serious risks associated with the drug but failed to inform the FDA promptly.

Baycol • FDA Opens Baycol Probe • Studies Allege Bayer Was Too Slow Withdrawing Baycol

The FDA has been under growing scrutiny since a series of articles in last week's Journal of the American Medical Association (JAMA), including a report of a new study which found that Baycol's risks were far worse than had been believed at the time Bayer withdrew the statin drug, taken to lower cholesterol.

The JAMA articles linked Baycol to at least 31 deaths involving a fatal muscle disorder called rhabdomyolysis. One article, written by University of Washington medical professor Bruce Psaty alleged that Bayer was aware of the risks of Baycol within months of its launch in February 1998, more than three years before it was withdrawn.

By the time Baycol was removed from the market, the estimated number of cases of rhabdomyolysis had reached the tens of thousands, one of the JAMA articles said. As of this fall, Bayer has settled 2,861 lawsuits involving Baycol.

The company says it has paid $1.1 billion so far, without admitting liability, in out-of-court settlements of cases related to Baycol side effects. Some 7,169 cases are still pending.

An FDA official said last week that if Psaty's charges are true, the FDA would take it "extremely seriously." Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said the agency would have its criminal investigators look into the allegations.

"Right now, we don't really know whether that's true or not. We read about it in this level of detail for the first time" in the JAMA article, Galson said in a C-SPAN appearance last week.

"Bayer kept FDA fully informed about all pertinent safety information, including adverse event reports," a company statement said. "Indeed, an FDA audit of Bayer's post-marketing practices during the time Baycol was on the market demonstrated no deficiencies."

The articles follow concern about FDA's role in the recent voluntary market withdrawal of Vioxx, a COX-2 inhibitor manufactured by Merck that has been linked to increased cardiac risks.

With increasing pressure on Congress to beef up drug safety enforcement, it's increasingly likely a separate agency will be created to police drugs after they have been approved.

Sen. Edward Kennedy (D-Mass.), who is drafting drug safety legislation, predicted that reform bills would receive "bipartisan support," noting that "the FDA gold standard has been tarnished," The New York Times reported.

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