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Baycol
On August 8, 2001, Bayer Pharmaceutical removed the cholesterol drug Baycol from the market after reports of at least 40 deaths linked to use of the drug. According to the Food and Drug Administration (FDA), Baycol has been linked to numerous fatal cases involving an adverse muscle reaction known as rhabdomyolysis.
Baycol (cerivastatin), which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.
Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug. FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use.
Rhabdomyolysis is a life threatening condition in which muscle cells breakdown and release the contents of the muscle into the blood stream. According to the FDA, symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, fever, dark urine, nausea and vomiting. The lower back and calve areas are the most frequently impacted areas of the body. The FDA advises that in certain cases, the muscle injury is so severe that patients develop renal failure or other organ failure, which may be fatal.
700,000 Americans have taken Baycol. The FDA advises persons using Baycol to promptly consult their doctor.
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