BAYCOL

What is Baycol (cerivastatin)?

Baycol (cerivastatin), which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.

What are statins?

Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol.

While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.

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.

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.

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 urine.

What should I do if I think I'm having this reaction (rhabdomyolysis) to Baycol?

Stop the drug immediately and call your physician

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 cholesterol.

Are there any alternatives to Baycol?

There are five (5) other drugs in the same class (statins) available in the US 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.

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 statins.

Background: Rhabdomyolysis was first described in the victims of crush injury during the 1940-1941 London, England, bombing raids of World War II. It has many etiologies.

Pathophysiology: Rhabdomyolysis is the breakdown of muscle fibers with leakage of potentially toxic cellular contents into the systemic circulation. The final common pathway of rhabdomyolysis may be a disturbance in myocyte calcium homeostasis.

Rhabdomyolysis is a side effect to Baycol/Lipobay and is a life-threatening condition in which muscle cells breakdown and release the contents of the muscle into the blood stream. 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.

Symptoms of rhabdomyolysis include the following: muscle pain, weakness, tenderness, fever, dark urine, nausea and vomiting.