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BAYCOL, CHOLESTEROL LOWERING DRUG,
FOUND TO CAUSE DEADLY MUSCLE CONDITION
CALLED RHABDOMYOLYSIS
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Ashcraft & Gerel
LLP
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BAYCOL, CHOLESTEROL LOWERING DRUG,
FOUND TO CAUSE DEADLY MUSCLE CONDITION
CALLED RHABDOMYOLYSIS
[Introduction: Although our offices are located in Maryland (MD), Virginia (VA) and Washington, D.C. (DC), our drug and pharmaceutical practice is national in scope, and our lawyers are handling many drug cases around the country. Therefore, regardless of what state you're in, please complete our inquiry form on this web site or email us so that we can have an attorney from our drug litigation department contact you.]
1. What is Baycol?
Baycol (cerivastatin sodium) is a cholesterol-lowering drug that was initially approved in the U.S. in 1997. A member of the class of drugs known as statins, Baycol lowered cholesterol levels by blocking a specific enzyme in the body that is part of the synthesis of cholesterol. Studies of Baycol showed that the drug was effective in reducing total cholesterol, LDL cholesterol, and triglycerides, and increasing HDL cholesterol. The drug is used by about 700,000 Americans and about 6 million people worldwide.
2. Adverse Effects
The FDA reported that 31 people have died in the U.S. since January, 2000 due to severe rhabdomyolysis associated with the use of Baycol. Rhabdomyolysis is a rare and potentially fatal muscle reaction that causes the cells in muscles to breakdown and release the contents of the cells into the bloodstream. Symptoms can include muscle pain, weakness, malaise, tenderness, fever, nausea, vomiting, and the passing of dark urine. In rare cases, the condition can cause renal or other organ failure, which can be fatal. Twenty nine of the 31 people who died had kidney failure. The muscles of the calves and lower back are the groups most frequently involved with this condition. However, rhabdomyolysis can also cause injury symptoms. Other statins have also been connected with rhabdomyolysis, but the condition was 10 times more common in Baycol than any of the other statins.
3. Regulatory Action
Baycol has been voluntarily pulled from the market by its manufacturer, Bayer Pharmaceutical Division, on August 9, 2001. In December, 1999 Bayer changed the prescribing information for Baycol to include a contraindication to its use in combination with gemfibrozil. Then, in May, 2001 Bayer Corporation voluntarily made changes to the prescribing information of Baycol for the second time. These changes included a statement that the starting dose of Baycol should be 0.4 mg or lower and a statement in the "Warnings Section" regarding the increased risk of myopathy and rhabdomyolysis.
4. Population at Risk
The rhabdomyolysis cases have been found most frequently when used in higher doses (0.8 mg or higher), with elderly patients, and particularly when used in combination with gemfibrozil (LOPID and generics), another lipid-lowering drug. Twelve of the 31 deaths involved concomitant gemfibrozil use.
5. Precautions
Patients taking Baycol should talk to their doctors about alternative therapies to manage their cholesterol. Patients who are experiencing any of the symptoms of rhabdomyolysis or who are also taking gemfibrozil should discontinue use of the Baycol and contact their doctors. There are 5 other drugs in the statin class that are considered alternatives to Baycol.
6. Other Sources of Information
Ashcraft & Gerel is now accepting claims for injuries caused by Baycol. We have been a leader in mass tort and product liability cases and settlements, including asbestos, breast implants and tainted blood. Our lawyers have been at the forefront of the Fen-Phen diet drug claims, Rezulin litigation, Propulsid litigation and PPA litigation, and we are well situated to see the Baycol cases to a successful damage recovery for our clients. We have a toll free number to answer your questions with regard to your specific case. That number is 1-800-725-6470. If you would prefer, please feel free to e-mail us or complete the help inquiry form on this web site. Please be sure to include your name, address, telephone number (if you wish to be called), email address and the exact nature of your question so that we can provide you with the specific information you seek.
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