Starting in 1999, Bayer and the FDA have had a shared, ongoing concern over the practice of co-prescribing statins, including Baycol, with gemfibrozil to achieve more aggressive effects on lipid levels.
Relative to other statins, the reporting rate of rhabdomyolysis with Baycol appears to be more pronounced when gemfibrozil is co-prescribed and also with high-dose therapy alone, especially when not used as directed. Rhabdomyolysis is a rare condition characterized by generalized muscle weakness.
Recently, Bayer concluded that labeling agreed upon with the FDA, as well as communication campaigns conducted by the company during the past two years, have not been effective enough to prevent rhabdomyolysis through the reduction of co-prescribing.
During recent discussions with the FDA, Bayer proposed the following actions:
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