On Aug. 8, 2001, after only four years on the market, the
manufacturer of Baycol, Bayer A.G., pulled it from the U.S. market. At
its peak some 12 million people were taking Baycol (also known as
Lipobay, Cholstat or Cerivastatin). During its short life, Baycol had
become the most popular among a new and highly effective class of
cholesterol-lowering drugs called “statins”. Statins work by blocking a
liver enzyme associated with the production of cholesterol.
The Dangers of Baycol
Baycol was connected with deaths due associated with rhabdomyolysis,
a muscle disorder that can cause renal failure. The Food and Drug
Administration said testing showed a clear link between the drug and
the disease. Rhabdomyolysis destroys muscle cells and releases
byproducts into the bloodstream, which can damage the kidneys and lead
to possible renal failure.
The condition is more likely to be found in the elderly who took
higher doses of Baycol (also called Lipobay when sold in other
countries) and those who took Baycol in combination with another drug,
gemfibrozil (or Lopid by brand name).
Am I in Danger?
Symptoms of rhabdomyolysis include dark or brown colored urine,
muscle tenderness, weakness, fever, nausea, vomiting and general
malaise. Pain from the disease can be generalized throughout the body
or involve specific muscle groups, often in the lower back and calves.
Questions and Answers about Baycol from the FDA:
1. What should I do if I am taking Baycol?
If you are taking Baycol, contact your physician to discuss
alternative medications. If you are taking Baycol and experience muscle
pain, discontinue Baycol immediately and contact your physician for
2. What should I do if I am taking Baycol and gemfibrozil (Lopid)?
If you are taking Baycol and gemfibrozil (LOPID), discontinue the
Baycol immediately and contact your physician for further advice.
3. What is rhabdomyolysis?
Rhabdomyolysis is a very rare condition where serious muscle damage
results in release of muscle cell contents into the bloodstream. On
very rare instances, rhabdomyolysis may result in kidney damage and
other organ damage which may be fatal.
4. How do I know if I am having this serious reaction (rhabdomyolysis) to Baycol?
Patients who develop rhabdomyolysis often have muscle aches
involving their calves, back, or their entire body. The pain may be
accompanied by weakness, fever, nausea, vomiting, and passing of dark
5. What should I do if I think I’m having this reaction (rhabdomyolysis) to Baycol?
Stop the drug immediately and call your physician.
6. What is Baycol used for?
Baycol is a cholesterol-lowering drug belonging to a class of drugs
known as “statins”. It is prescribed to reduce your cholesterol and to
reduce your risk of heart disease.
7. Will I have any problems if I stop Baycol?
If you were prescribed Baycol to lower your cholesterol, these
levels may go back to where they were before you received the drug.
These changes will not occur immediately but will most likely occur
over a couple of days to weeks. If you stop Baycol, be sure to consult
your physician to discuss alternative therapies for lowering your
8. Are there any alternatives to Baycol?
There are five (5) other drugs in the same class (statins) available
in the U.S. market. They are atorvastatin (Lipitor), fluvastatin
(Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and
simvastatin (Zocor). There are also other drugs approved for lowering
cholesterol that are not statin drugs. You should consult you physician
to determine which treatment is right for you.
9. Do the other statins have the same safety concerns as Baycol?
All statins have been associated with very rare reports of
rhabdomyolysis. These rare cases can occur when the drugs are used
alone or in combination with another lipid-lowering drug such as
gemfibrozil. However, cases of fatal rhabdomyolysis in association with
Baycol use have been reported more frequently than other approved