http://bmj.com/cgi/content/full/323/7310/415/a

BMJ 2001;323:415 ( 25 August )

News

Bayer faces potential fine over cholesterol lowering drug

Annette Tuffs, Heidelberg

Bayer, the German company that was forced earlier this month to withdraw a cholesterol lowering drug from the market, might have to pay a fine of DM50000 (£16200; $23400) for withholding from the German authorities information on the drug's potentially fatal interaction with another drug.

Bayer's drug, cerivastatin (Baycol in the United States, Lipobay in the United Kingdom), was withdrawn after 52 deaths occurred in patients taking the drug; 31 of the deaths were in the United States (18 August, p 359). Now the German health ministry has accused Bayer, based in Leverkusen, between Dösseldorf and Cologne, of withholding vital information from its federal drug agency.

"We did not receive any information about a new study showing the adverse risks of Lipobay until we asked for it on 10 August," said the secretary of health, Klaus Theo Schroeder.

Schroeder criticised the regulation that pharmaceutical companies have to inform only the European agency responsible for the authorisation of the particular drug, in this case the Medicines Control Agency in the United Kingdom. Nevertheless, Bayer might have to pay a fine for withholding information, the ministry said.

Bayer denies that any information was withheld. "Relevant information was given to the German drug agency before 28 April 2001," the company says. "Furthermore, the Medicines Control Agency issued an interpretation of this information at the same time and sent it to its European partner agencies."

Bayer stated that the Medicines Control Agency received a final report on 18 June and that changes to the prescription information for Lipobay were then made.

Bayer also insists that Lipobay's adverse effects were not apparent before the introduction of the drug and that a causal relation is not proved. Patients who died had been taking a combination of Lipobay and another anticholesterol drug, gemfibrozil, which lowers blood concentration of triglycerides.

"The drug was tested in 50 studies with more than 2500 patients," said a spokesman. After the authorisation further studies were done on 15000 patients.

The German health ministry welcomed the preparation of a law that will strengthen German patients' rights to compensation for the adverse effects of drugs, even if it is not 100% certain that the drug is the cause. However, the justice ministry points out that this law was drafted independently of the recent events concerning Lipobay.

© BMJ 2001
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