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Reports to FDA Were Late, Watchdog Says

Reactions to Cholesterol Drug Cited

By Marc Kaufman
Washington Post Staff Writer
Wednesday, August 4, 2004; Page E02

At least 23 serious adverse reactions to the cholesterol-lowering drug Crestor were not reported to the Food and Drug Administration until weeks or months after they were legally required, a drug watchdog group charged yesterday.

In a letter to the FDA, Public Citizen's Health Research Group called for criminal investigation into the maker of Crestor, AstraZeneca PLC, for keeping the information from the agency.

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"I learned from people in the FDA that they were infuriated that it took so long to get the reports and told the company to stop doing it," said group director Sidney M. Wolfe, who has called on the agency to take Crestor off the market. "This kind of delay happens frequently, but this is a particularly extreme example."

An AstraZeneca spokeswoman said that the company had given the FDA all the required information required on a timely basis. In a statement, the company called the charge "one more false, misleading, and inaccurate report from Mr. Wolfe and his organization."

At the FDA, division deputy director Mary Parks said the company has been cooperating with the agency and she was unaware of any delays in reporting Crestor's side effects. FDA officials declined to discuss Wolfe's statement that the agency had spoken to AstraZeneca about the timing of the reports.

AstraZeneca says Crestor, which the FDA approved last year, has been used by more than 2.8 million patients. The adverse reactions reported by Wolfe, which he said came from the FDA's reporting system, involve the muscle-destroying condition rhabdomyolysis and associated kidney failure.

Wolfe said 20 of the 23 cases reported by AstraZeneca in 2004 led to hospitalizations and would be considered "serious adverse drug experiences" under federal rules. He also said the reports should be considered "unexpected adverse drug experiences" because the only mention of rhabdomyolysis in the drug's labeling refers to clinical trials of higher-than-recommended doses. Adverse reactions that are both "serious" and "unexpected" must be reported to the FDA within 15 days, he said.

But company spokeswoman Rachel Bloom-Baglin said Crestor's label lists rhabdomyolysis as a possible side effect in several places and so should not be considered "unexpected." As a result, she said, FDA rules give the company three months to report any possible cases.

In addition, she said, AstraZeneca has often told doctors and patients that smaller doses of Crestor, like all cholesterol-lowering drugs, can cause rhabdomyolysis in a small number of patients.

FDA officials said the agency will look into Public Citizen's complaint.

It is rare for reporting infractions to result in criminal charges, but it has happened at least twice. In 1985, GlaxoSmithKline (which was then SmithKline Beckman Corp.) pleaded guilty to 14 counts of failure to report adverse reactions to the blood-pressure drug Selacryn. Several months later, Eli Lilly and Co. pleaded guilty to failing to report adverse reactions associated with the arthritis drug Oraflex.

Wolfe's charges come as medical professionals are recommending that more Americans take drugs to lower their cholesterol levels. An estimated 11 million Americans are already taking the drugs, which include Zocor, Lipitor and Pravachol, and the National Institutes of Health's National Cholesterol Education Program recently said that between 36 million and 40 million Americans would benefit from taking cholesterol-lowering drugs, called statins.

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