Cerivastatin (Baycol) and gemfibrozil (July 25, 2001)

Health Canada and the Bayer Corporation are reminding health care professionals that combination therapy of cerivastatin and gemfibrozil is contraindicated due to increased risk of rhabdomyolysis. Further, the US Food and Drug Administration is clarifying that starting doses above 0.4 mg per day increases the risk of rhabdomyolysis.

The drugs

Cerivastatin is a member of the statin class of medications, which inhibit HMG-CoA reductase and cholesterol biosynthesis. Gemfibrozil is another lipid-regulating agent of the fibric-acid class. Health Canada reports show that between March 1998 and June 30, 2001, there were 31 cases of rhabdomyolysis among people who had taken cerivastatin; 8 of the cases resulted in renal failure and there was 1 death. Of the 31 cases reported, 9 occurred in patients receiving concomitant treatment with gemfibrozil. Cases of rhabdomyolysis have been reported for all statin medications.

Rhabdomyolysis is characterized by marked increases in creatine phosphokinase (CPK) (> 10 times the upper limit of normal), and possible myoglobinemia and myoglobinuria, renal failure and death. Symptoms can include spontaneous myalgias, muscle tenderness, weakness, malaise and fever. For other medication adverse effects, including elevation of hepatic transaminases, consult the product monograph.

Cerivastatin is marketed in Canada under the brand name Baycol. Gemfibrozil is marketed in Canada under the brand names Apo-Gemfibrozil, Gen-Fibro, Lopid, Novo-Gemfibrozil, Nu-Gemfibrozil, PMS-Gemfibrozil.

What to do

Patients receiving cerivastatin should be made aware of the potential for rhabdomyolysis and told to report adverse symptoms as soon as possible. If myopathy is suspected or confirmed, treatment with cerivastatin and gemfibrozil should be discontinued.

The recommended starting dose of cerivastatin is 0.2 mg once daily in the evening, with an eventual dose range of 0.2 to 0.8 mg, individualized to a patient's therapy goals. The US Food and Drug Administration warns that a starting dose above 0.4 mg increases the risk of myopathy and rhabdomyolysis.

— Dr. Eric Wooltorton, eCMAJ

Copyright 2001 Canadian Medical Association or its licensors