Drug Injury Lawyer

Baycol®

Consult with your physician if you have questions concerning this medication.

Baycol® & Kidney Failure
Baycol®, brand name for cerivastatin [“seh-RIH-va STAHtin”], is a drug in the “statin” class prescribed to help lower cholesterol. After four years on the market, Baycol was withdrawn on August 8, 2001. As of January 2002, Baycol had been linked to 100 deaths in the U.S. It can cause skeletal muscle damage leading to a condition called rhabdomyolysis [“rab-do my OHL-uh-sis”], which can result in kidney failure and death.

What is Baycol?
Baycol is one of several drugs known as "statins," which help lower the so-called "bad kind" of cholesterol (low density lipoproteins or "LDL"). It does this by promoting production of high-density lipoproteins (HDL), the "good" cholesterol that lowers the artery-clogging risk of high levels of LDL.

Why is it dangerous?
The most serious complication associated with Baycol was rhabdomyolysis. Rhabdomyolysis can damage skeletal muscle and cause kidney toxicity; this condition can lead to kidney failure and death. According to the FDA, at the time of the withdrawal of Baycol, it had received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with Baycol use.

Risk of this fatal condition increased when Baycol was used at higher doses, in elderly patients and when in combination with gemfibrozil ["jem FI-bro zil"], a drug that helps control different fatty substances in the bloodstream. Product labeling warned against possible drug interactions with gemfibrozil, but they continued to be prescribed together despite the warnings. About a third of the deaths associated with Baycol at the time involved use with gemfibrozil.

Regardless, Baycol was proven responsible for deaths and dangerous health problems by itself, and new data continues to confirm these risks. In a study published in the Dec. 1, 2004, issue of the Journal of the American Medical Association, the risk of developing the muscle disorder with Baycol was 10 times higher than for other statins; when combined with gemfibrozil, on average, 1 in 10 patients would develop rhabdomyolysis. Baycol has now been linked to over 100 deaths total.

What is rhabdomyolysis?
Rhabdomyolysis ["rab-do my OHL-uh-sis"] is a rare condition in which skeletal muscle is damaged and toxins are released into the bloodstream. It is sometimes seen in people who undergo extreme physical exertion, when muscles are pushed past the point of overwork. The muscles’ breakdown releases myoglobin (a cell protein that contains iron), which then circulates in the blood. Myoglobin builds up in the kidneys to the point of toxicity. This is how Baycol has led to deadly kidney failure in a significant number of patients who were prescribed with it.

What are the warning signs?
Rhabdomyolysis can ultimately lead to kidney failure and heart attack, so it is important to be aware of the signs and symptoms. Symptoms of rhabdomyolysis can include:

• Pain
• Muscle weakness and tenderness
• Muscle contractions.
• Fever
• Tachycardia (rapid heartbeat)
• Nausea
• Vomiting
• Dark urine
  

What has been done about this danger?
On August 8, 2001, Bayer voluntarily withdrew Baycol after four years on the market. All statins were recognized for carrying a slight risk of kidney complications, but after the FDA had received 31 reports of rhabdomyolysis deaths linked to Baycol, it was found to carry a higher risk than all other statins on the market.

What should I do if I took Baycol?
Because Baycol was withdrawn in August 2001, there should not be any people currently taking this medication. But if you took Baycol in the past and were hospitalized or your doctor took you off the drug due to muscle-related problems, you may be entitled to compensation. Contact our lawyers today for an immediate and confidential evaluation of your case.

Sources:

1. Graham, et al, “Incidence of Hospitalized Rhabdomyolysis in Patients Treated With Lipid-Lowering Drugs,” Journal of the American Medical Association, 1 Dec. 2004.
   

Consult with your physician if you have questions concerning this medication. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Baycol® is a registered trademark of Bayer Corporation. The reference to the registered trademarks of Bayer Corporation is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by or associated with Bayer Corporation or the FDA.

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