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Bayer faces shake up after Lipobay withdrawn

BMJ 2001; 323 doi: https://doi.org/10.1136/bmj.323.7317.828g (Published 13 October 2001) Cite this as: BMJ 2001;323:828
  1. Annette Tuffs
  1. Heidelberg

    Two months after the withdrawal of cerivastatin (Lipobay) from the market because of associated deaths, the German manufacturer, Bayer, is still facing possible damaging consequences. In particular, it faces a collective legal claim by patients in the United States and is also having to restructure the firm.

    In August Bayer decided to take cerivastatin off the market when several cases of deaths due to rhabdomyolysis came to light as a presumed consequence of high dose cerivastatin, especially in combination with another cholesterol lowering drug gemfibrozil (18 August, p 359).

    There was a public outcry in Germany over Bayer's information policy—shareholders were informed before doctors and patients.

    Major financial and job losses at Bayer have led to the decision to replace the firm's chief executive officer, Manfred Schneider, with Werner Wenning, currently responsible for financial affairs at Bayer. Mr Wenning will take up the post in April 2002. The health section of Bayer will become an independent unit, and Bayer is looking for strategic partners.

    However, in retrospect Bayer seems to have followed the rules of the European Drug Agency and might have just been unwise in its public communication strategy.

    The German Federal Drug Agency and the health ministry had to admit that Bayer's decision to selectively inform the United Kingdom's Medicines Control Agency that, according to relevant information, cerivastatin and gemfibrozil should not be taken together was correct as the drug had had been registered first with that agency. Consequently, other agencies in European Union countries were informed by the Medicines Control Agency.

    However, the German Drug Agency said it regretted that it did not receive information at the same time as the Medicines Control Agency and that a “Dear doctor” letter could not therefore be sent out in Germany immediately. However, the German agency had been aware of a problem with cerivastatin before. Cases of possible side effects of cerivastatin (often in combination with gemfibrozil) were increasingly being registered with the agency. It seems that some doctors did not follow the changes made in the advice issued for using the drug and carried on prescribing high doses and combinations with gemfibrozil.

    In Germany about 1000 cases of possible severe side effects have become known, seven of them leading to death. About 800 German patients joined a self help group started near Berlin and are going to join the collective legal claim in the United States. However, Bayer does not believe that the claim will succeed and will therefore fight it, a spokesperson from Bayer said.

    The European Drug Agency currently reviews the risk potential of all available statins on the market. Whether Bayer will reapply for cerivastatin provided that the analysis shows that its risks are acceptable and comparable with similar drugs has to be considered at the time, a spokesperson from the company said.

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