Bayer to pull out Baycol globally

Our Corporate Bureau

Mumbai, Aug 8: German multinational, Bayer, has decided to withdraw all dosages of its cholesterol-lowering drug, branded Baycol (Lipobay in India), throughout the world, except Japan, with immediate effect.

Bayer has, in an official statement, said that this voluntary action was prompted by “increasing reports of side-effects involving muscular weakness (rhabdomyolysis), especially in patients who have been treated concurrently with the active substance gemfibrozil, despite contraindication and warnings contained in the product information.” Japan is unaffected by this move because gemfibrozil is not available there.

Bayer had launched Lipobay (cerivastatin) in India around nine months ago, though the launch was restricted to around 10 cities. Analysts peg Lipobay sales (March to June 2001) at around Rs 15 lakh, while sales of competitor Torrent’s brand, Seriva, are also in the same region. It is unclear whether Indian drug authorities are planning any preventive action locally.

“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,” Bayer head (pharmaceutical business group) Dr David Ebsworth said in an official statement. Any possible resumption of the marketing of certain dosages of Baycol/Lipobay will be subject to extensive consultations between Bayer and regulatory authorities, the statement said.