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Baycol was initially introduced onto the US market in 1997. Baycol is a member of a family of drugs known as " Statins".
Other statins include: Lipitor, Zocor, Pravachol, Crestor, Lovastatin, Advicor. Statins reduce your cholesterol by blocking the liver from producing cholesterol.
Baycol was marketed by the Bayer Corporation (a large German company) with help from GlaxoSmithKline (a large British company).
Important Background Information:
Think of your liver as being a cholesterol factory. Even if your diet was 100% fat-free, your body would still manufacture cholesterol because it is used to create certain hormones and cell membranes.
There are two types of cholesterol - LDL and HDL. HDL cholesterol is good for you. Doctors call HDL the " Good Cholesterol". LDL on the other hand is the "Bad Cholesterol". High levels of LDL cholesterol are associated with diseases such as heart attack and stroke.
Cholesterol peak production in your body takes place at night. That is why most people take their statin medication at bedtime.
How did Baycol work?
Baycol worked directly in the liver. Baycol was able to reduce the liver's ability to manufacture the bad cholesterol (LDL).
Baycol was a potent medication. The normal dose of Baycol was either 4/10 of a milligram ( 0.4 mg) or 8/10 of a milligram ( 0.8mg).
As a comparison of Baycol's potency, you should know that other statins such as Lipitor or Zocor have minimum doses of 10 milligrams; more than 10 times the number of milligrams than Baycol.
What went wrong with Baycol?
For some reason, Baycol had a higher than usual rate of producing a condition known as rhabdomyolysis.
When somebody gets rhabdomyolysis, their muscle tissue breaks down and releases toxic chemicals into the bloodstream. These toxic chemicals from the breakdown of the muscle tissue can lead to kidney failure, hyperkalemia ( abnormally high blood levels of potassium) and cardiac arrest.
Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body.
In August of 2001, the FDA reported that 31 Americans died as a result of severe rhabdomyolysis associated with taking Baycol. Of these 31 deaths, 12 of them were mixing the Baycol with another cholesterol lowering drug known as gemfibrozil.
At this point, the manufacturer of Baycol ( the Bayer Corporation) decided that it would recall Baycol from the market. People that were taking Baycol to reduce their bad cholesterol levels were switched to other medications.
The withdrawal of Baycol lead to a legal feeding frenzy. Lawyers hope to find people that were injured by Baycol. They sue Bayer for damages if they find a client who was injured by Baycol.
In September of 2003, Bayer announced that it had settled 1,342 Baycol lawsuits for $477 Million.
That's an average of $355,000 per case.
The lawyer gets 1/3 off the top. The victim gets the rest.
Baycol Information On The Internet:
Baycol Package Insert from South African database SAEPI
Baycol Information (from The FDA) ; Talk Paper (background information), Baycol Questions and answers, Dear Doctor Letter that Bayer sent out telling health professionals that it was recalling Baycol.
Baycol Edited Press Release announcing availability of 0.8mg strength…[ Doctor's Guide ]
Baycol Dear Dr. Letter, 5/21/01
Baycol Scientific Papers ( from the National Library of medicine) a listing of scientific papers in abstract form regarding Baycol.
Baycol News ( from Google) ; recently published news regarding Baycol.
Baycol Patient Information (from Rx List; the #1 drug information site on the internet) this is a flyer that many people taking Baycol got from the drugstore when they filled their Baycol prescription.
Baycol Prescribing Information ( from Rx List; the #1 drug information site on the internet) ; prescribing information; dose, mechanism of action, side effects, precautions, patient information.
Rhabdomyolysis (from Medline Plus; a service of the US Government) ; definition of rhabdomyolysis, illustrations, causes and risk factors, symptoms, tests, treatments, etc.
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