The pullout comes in the wake of increasing reports of side effects involving muscular weakness (rhabdomyolysis), especially in patients who have been treated concurrently with the active substance gemfibrozil despite a contraindication and warnings contained in the product information.
Japan is unaffected by this move because gemfibrozil is not available there.
"We have decided on this action in the interest of patient safety. We will continue to conduct further assessments over the next few months to evaluate the benefit/risk ratio of cerivastatin," explained Dr. David Ebsworth, head of Bayer’s Pharmaceuticals Business Group.
Any possible resumption of the marketing of certain dosages of Baycol/Lipobay will be the subject of extensive consultation between Bayer and the regulatory authorities.
In view of the financial burden and loss of earnings for Bayer’s Health Care segment resulting from the withdrawal of its cholesterol-lowering drug, as well as the continuing weakness of the world economy, it is now assumed that earnings for the full year will fall substantially short of previous estimates.
The target of a 20 percent return on sales (before exceptional items) in the Health Care segment in 2002 can no longer be met.