United States of America - The manufacturer of cerivastatin sodium (Baycol®), approved for the treatment of hyperlipidaemia, has announced its decision to discontinue the marketing and distribution of cerivastatin in the United States (1).

In a letter from Bayer dated 21 May 2001 (2), the section on dosage and administration was revised to highlight 0.4 mg as the starting dose once daily, in the evening, regardless of previous lipid therapy, in response to post marketing reports of muscle weakness and rhabdomyolysis. A substantial number of these cases occurred in patients receiving cerivastatin in a manner inconsistent with product labelling, such as concomitant therapy with gemfibrozil.

Ongoing scrutiny of post marketing reports has revealed an increased reporting rate of rhabdomyolysis relative to other statins, especially when gemfibrozil is co-prescribed. The data also suggest an increased reporting rate of rhabdomyolysis at the 0.8 mg dose of cerivastatin alone. Since the co-prescription of cerivastatin with gemfibrozil has continued despite communications from the manufacturer against this practice, all dosage strengths of cerivastatin have now been discontinued and patients should be switched to an alternative therapy.

Although rare cases of rhabdomyolysis have been reported with all statins, fatal reports have been received most frequently when used at higher doses, when used in elderly patients and particularly when used in combination with gemfibrozil (3). The Food and Drug Administration has received reports of 31 deaths due to severe rhabdomyolysis associated with use of cerivastatin.

Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Patients should report to their physician unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

There are five other statins available that may be considered alternatives to cerivastatin: lovastatin, pravastatin, simvastatin, fluvastatin and atorvastatin (3).

References

1. Letter from Bayer dated 8 August 2001 http://www.fda.gov/medwatch/safety/2001/Baycol2.htm.

2. Letter from Bayer dated 21 May 2001 http://bayerpharma-na.com

3. FDA Talk Paper, T01 - 34 (2001).