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Wednesday, 8 August, 2001, 17:10 GMT 18:10 UK
Heart drug pulled after deaths
Medicines in a US shop
The drug has been taken off the shelves
German drugs giant Bayer has pulled one of its top-selling products after it was linked with 31 deaths in the US.

Bayer said it was withdrawing its cholesterol-lowering drug Baycol/Lipobay with immediate effect because of reports the drug was associated with side effects including fatal muscular weakness.

We have decided on this action in the interest of patient safety

Bayer spokesman
The US Food and Drug Administration (FDA) said it backed the decision and knew of 31 deaths in the US which were associated with the drug, also known as cerivastatin.

Bayer's shares fell 16% on the news after estimates the drug's withdrawal would lose the company more than $800m in sales this year. More than 700,000 people take it in the US alone.

Baycol, which was approved in the US in 1997, is one of several drugs available known as statins. These help lower the body's cholesterol levels.

Fatal cases

The FDA said all statins had been linked with very rare reports of severe muscle reaction, but that fatal cases associated with Baycol had been "significantly" more frequent.

Drug testing
The FDA first warned about the drug in 1999

The FDA said patients already taking Baycol should consult their doctor about switching to another product.

Symptoms of the adverse side effects include muscle pain, especially in the calves and lower back, as well as malaise and vomiting. In severe cases, the patient's liver or other organ stops working.

Patients who start to feel muscle pain should stop taking Baycol immediately and call their doctor, the FDA said.

Bayer said problems with the drug seemed to be more common among patients also taking another drug, gemfibrozil. Since gemfibrozil is not available in Japan, Bayer will continue to supply Baycol there.

The FDA, which warned about using Baycol with other products in 1999, said only 12 of the 31 patients who had died were also taking gemfibrozil.

It said Baycol's fatal side effects were also reported to be more frequent when the drug was taken in high dosages, and among the elderly.

Commerzbank's Michael O Sullivan
Bayer has now become a takeover target
See also:

08 Aug 01 | Business
Bayer shares plunge
27 Jun 01 | Business
Bayer warns on 2001 profits
22 Jun 01 | Business
Drug giant warns of lower profits
21 Jun 01 | Business
BASF shuts plants
21 Nov 00 | Business
Drugs - a high-risk business
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