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Baycol and Lipobay,
generically known as Cerivastatin, was approved by the FDA for sale
in the United States in 1997. It was prescribed for treatment of
hypercholesterolemia, (elevated Cholesterol levels) which is a known
risk factor for coronary artery disease and heart attacks. It is
a member of a class of cholesterol lowering drugs known as “statins.”
Statins are effective at lowering cholesterol by blocking a specific
enzyme that is involved in the body’s synthesis of cholesterol.
Statins have been known to cause muscle cell damage and, in extreme
cases, Rhabdomyolysis,
a condition that results in muscle cell breakdown and the release
of the contents of muscle cells into the bloodstream. The onset
of Rhabdomyolysis has
been significantly higher with use of Baycol than with any other
statin.
Before Baycol was introduced to the market, the manufacturer, Bayer
Corporation, had conducted clinical trials to determine any potential
complications with the drug. Despite findings that Baycol posed
serious health risks, Bayer continued to seek FDA approval for higher
dosages of the drug. As a result recommended dosages increased from
.2 mg to .8 mg., even though Bayer had knowledge of Rhabdomyolysis
causing death and kidney failure in Baycol users as early as January,
2000. The associated dangers of the drug increased as the dosage
increased. After receiving reports of an increased number of serious
Rhabdomyolysis cases,
Bayer adjusted the recommended dosage level in May of 2001.
On August 8, 2001 Bayer voluntarily recalled Baycol. This announcement
came after numerous reports of sometimes fatal Rhabdomyolisis.
At the time 31 deaths had been linked to the drug. In 12 of the
31 cases, the victims were taking Baycol in combination with gemfibrozil
(Lopid), another lipid reducing medication. Since then, at least
100 deaths have been linked to the drug.
Many Baycol victims have now brought claims or filed suit in state
and federal courts.
If you feel you have been harmed by use of Baycol, click
here to have an attorney review your case for free, with no
obligation. Or, call us toll free at 877.786.1LAW (1529). |