What is all the fuss about with Baycol?

All the fuss is over the fact that Baycol is linked to 31 deaths in this country and 52 deaths around the world. On August 8th, 2001, Bayer AG withdrew Baycol from the market after concerns about lethal side effects related to the breakdown of muscle cells. Baycol, also called cerivastatin, is still available in Japan.

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What should you do if you take Baycol?

Patients now taking Baycol need to see their doctors about switching to a different medication. If you are taking one of the other statins that remain on the market (Zocor, Pravachol, Mevacor, Lescol and Lipitor), FDA spokespersons have said that there is no need to panic. These older drugs have been prescribed to thousands of patients for more than a decade without causing similar problems.
However, as a general rule, no statin should be used in combination with gemfibrozil, which heightens the risk of muscular disorders. Anyone taking a statin who experiences muscle pain should consult their doctor to make sure they are not at risk for certain side effects.

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Is the problem limited to Baycol, or do other statins do the same thing?

All statins have been linked to a disease called Rhabdomyolysis, a potentially life threatening disease in which muscle cells are destroyed and released into the blood stream. However, only Baycol has caused muscle problems that have resulted in fatal results. It is not yet known whether other statins can cause actual Rhabdomyolysis.
If you are taking a statin other than Baycol such as Zocor, Pravachol, Mevacor, Lescol and Lipitor, talk to your doctor or healthcare professional to make sure that you are not in danger of developing Rhabdomyolysis.

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What is Rhabdomyolysis?

Rhabdomyolysis is a disorder that involves myoglobin, a protein found in red skeletal muscle. When damage occurs to the skeletal muscle, the myoglobin is sloughed off into the bloodstream where it would normally be filtered by the kidneys. However, if enough material enters the bloodstream, it can reduce the blood flow to the kidneys and block this organ's ability to properly function and lead to kidney failure. The myoglobin can also cause kidney failure if, when it breaks down, it does so into toxic compounds. The shift of body fluids from the bloodstream into the muscle can send the body into shock. Kidney failure can certainly result in death if the necessary medical steps are not taken.

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Are there any precautions to take if you are on a statin?

Anyone who now takes Baycol will need to see their doctors about switching to another of the statins on the market. According to FDA spokespersons, patients taking the more established statin drugs should not create any additional concern. These older drugs have been used in hundreds of thousands of patients for more than a decade without causing similar problems. The FDA does not plan to strengthen the warning labels currently on statins or to ask other manufacturers to pull their products.
However, as a general rule, no statin should be used in combination with gemfibrozil, which heightens the risk of muscular disorders. Anyone taking a statin who experiences muscle pain should consult their doctor to make sure they are not at risk for certain side effects. A simple blood test can tell you if the statin drug is causing any skeletal muscle destruction and should therefore be stopped.

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How do you know if you are experiencing Rhabdomyolysis from taking Baycol?

Patients who develop rhabdomyolysis often have darker than normal urine, sore muscles (often in the lower back or calves), weakened muscle(s), stiff or aching muscles, overall body fatigue, joint pain, seizures, and unintentional weight gain.

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Are there dangers associated with discontinuing Baycol?

In all likelihood, if you stop taking the drug, your cholesterol levels will return to you pre-statin levels. It usually takes several weeks for this to occur. The best step is to see you doctor and discuss alternative statins that are still available.

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What are the alternative statins on the market?

There are five other statins currently available in the U.S. market. They are simvastatin (Zocor), atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), and pravastatin (Pravachol). There are also other drugs approved for lowering cholesterol that are not statin drugs. Consult with your doctor to find the best decision for your particular situation.

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Are there drugs that could affect Baycol?

The following medications may interact with Baycol and pose the risk of muscle damage. Talk with your doctor if you are taking any of the following:

· Gemfibrozil (Lopid)
· Clofibrate (Atromid-S)
· Fenofibrate (Tricor)
· Cyclosporine (Sandimmune, Neoral)
· Niacin (Nicolar, Nicobid, Slo-Niacin, others)
· Erythromycin (E-Mycin, E.E.S., Ery-Tab, others)
· Clarithromycin (Biaxin)
· Itraconazole (Sporanox)
· Fluconazole (Diflucan)
· Ketoconazole (Nizoral)

Drugs other than those listed here may also interact with Baycol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

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Can you drink alcohol while taking a statin?

Alcohol and cerivastatin can both damage your liver. To prevent damage to your liver, drink alcohol in moderation. Discuss the use of alcohol with your doctor so that it can be determined if cerivastatin is the best choice for lowering your cholesterol.

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Are there people who shouldn't take a statin?

Baycol and other statins should never be taken by pregnant women or nursing mothers. Cerivastatin passes into breast milk and can harm a nursing infant. As the brains and body of fetuses and infants grow, they require cholesterol for proper development. Statins such as Baycol can deprive them of these needed substances.

Statins can pose a health risk for alcoholics, anyone who suffers from liver or kidneys diseases or deficiencies, has a chronic muscular disease, or
has seizures or epilepsy.

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