Recently, Bayer Corporation has voluntarily made changes to the prescribing information for Baycol in order to provide patients with more specific guidance on initiating therapy with the product.

Bayer Corporation has made these revisions because they have received reports of muscle weakness and rhabdomyolysis during the post-marketing period. A substantial number of these cases occurred in patients receiving Baycol� in a manner inconsistent with product labeling: e.g. patients were treated with concurrent gemfibrozil therapy and/or received Baycol� 0.8mg as a starting dose. Rhabdomyolysis has been reported with all statins and is reflected in the corresponding prescribing information for all statins.

(via FDA - MEDWATCH)