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Baycol, also known as Cerivastatin is cholesterol lowering drug, recently withdrawn from United States markets because of reports of fatal rhabdomyolysis side effects, a severe muscle adverse reaction of the drug Baycol.
Baycol and Lipobay, generically known as Cerivastatin, were prescribed for treatment of hypercholesterolemia, (elevated cholesterol levels) which is a known risk factor for heart attack and coronary artery disease.
BAYCOL
On August 8, 2001 the FDA announced that Bayer Pharmaceutical Division will be voluntarily withdrawing Baycol (Cerivastatin) (also marketed under the name Lipobay) from markets in the United States. This shocking announcement came after numerous reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction linked to their cholesterol-lowering product Baycol. The FDA agrees with and supports this decision.
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Drug's Problems Raise Questions on Warnings
When Baycol, a cholesterol-lowering drug, was approved in 1997, it appeared to be a potentially lifesaving drug with few side effects. It had been tested on more than 3,000 patients, and no serious problems had turned up.
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E-mails put Bayer on the spot
Some Bayer officials were worried about growing reports of deaths associated with the company's anti-cholesterol drug 18 months before it was pulled from the market, newly disclosed company documents show. 'So much for keeping this quiet,' Patricia Stenger, a manager in Bayer's scientific affairs unit, told other executives in a February 2000 e-mail. Bayer (BAY) was then seeking critical approval from regulators to sell its Baycol drug at doses double those permitted in order to increase the drug's effectiveness and its sales, documents from lawyers suing the company show. The Food and Drug Administration gave its approval in July 2000.
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