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Lipobay, also known as Baycol is cholesterol lowering drug, recently withdrawn from United States markets because of reports of fatal rhabdomyolysis [More on rhabdomyolysis] side effects, a severe muscle adverse reaction of the drug Lipobay. Lipobay known as Baycol [More on Cerivastatin], were prescribed for treatment of hypercholesterolemia, (elevated cholesterol levels) which is a known risk factor for heart attack and coronary artery disease.
LIPOBAY
On August 8, 2001 the FDA announced that Bayer Pharmaceutical Division will be voluntarily withdrawing Baycol (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 Cerivastatin. The FDA agrees with and supports this decision.
Bayer Corporation's Pharmaceutical Division, headquartered in West Haven, Connecticut, voluntarily withdrew Lipobay from the U.S. market after reports of 31 deaths associated with use of Lipobay (Baycol) the United States. The cause of death was identified as rhabdomyolysis. Rhabdomyolysis is a severe muscle reaction that has been associated with the use of statins. According to published information, the incidence of fatal rhabdomyolysis was significantly higher for Cerivastatin users than for users of other cholesterol-lowering medications.
In 12 of the 31 cases, the victims were taking Cerivastatin in combination with gemfibrozil (Lopid), another lipid-reducing medication. Although Bayer reportedly warned against the concomitant use of Lipobay and gemfibrozil by adding new warnings to its Cerivastatin labels and Lipobay package inserts, the incidence of rhabdomyolysis continued.
Although, Bayer had knowledge of rhabdomyolysis causing death and kidney failure in Lipobay users, as early as January 2000, Bayer sought approval of higher dosages of the drug from the FDA. Bayer continued to seek higher dosages despite repeated reports of rhabdomyolysis deaths from their product. Many Lipobay victims have filed suit in state and federal courts.
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Lipobay and Rhabdomyolysis
Rhabdomyolysis is a muscle breakdown disorder where a breakdown of muscle fibers cause leakage of potentially toxic cellular contents into the systemic circulation. The final common pathway of rhabdomyolysis may be a disturbance in myocyte calcium homeostasis.
Rhabdomyolysis breaks down muscle components to be released into the blood circulation and detectable as an elevated CK level, usually five times higher than normal. These cells contain myoglobin, a toxic substance consisting of an iron containing pigment which the kidneys will try to remove from the blood stream reaction. The effects of Rhabdomyolysis may result in potentially life-threatening complications. Kidney failure can result when the myoglobin blocks or occludes the kidneys creating a toxic blockage resulting in kidney failure.
Cerivastatin Rhabdomyolysis symptoms include muscle ache and or tenderness in the back muscles, legs and arms. Other symptoms include fever, nausea, vomiting and a general feeling of weakness. Severe rhabdomyolysis symptoms may include, intense muscle pain, weakness, malaise, fever, dark urine, nausea and vomiting.
Rhabdomyolysis breaks down the muscle cells and releases the contents of the muscle cells into the blood stream.
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The greatest risk of injury or death is from Lipobay users who took it in combination with Lopid. Lopid is the trade name for Gemfibrozil, a fibrate. The two drugs alter blood fats in different ways. Other high risk groups include older patients and patients who were taking high doses of LIPOBAY (.8 milligram dose). On January 18, 2002, Bayer announced that the estimated number of worldwide deaths linked to Lipobay had risen to 100.
If you are taking Cerivastatin you should consult with your physician about switching to an alternative medication to control your cholesterol levels. Patients taking Lipobay who are experiencing muscle pain or are also taking gemfibrozil should discontinue Lipobay immediately and consult their physician.
If you or someone you know has been injured as a result of taking the prescription medication Cerivastatin, Cervistatin or Lipobay you should contact an attorney immediately. Click here to locate an attorney handing Cerivastatin Claims.
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