The British government warned the German pharmaceutical company, Bayer, in June 2001 that it needed to change the health warning labels for its anticholesterol drug Lipobay. This shows that the risks associated with the drug were well known months before Bayer withdrew Lipobay.
Under the EU’s Mutual Recognition Procedure (MRP), medicines may be approved on a European level when medicines are not manufactured by means of biotechnology. Such medicines can be approved when one or more Member States’ national agencies responsible for the regulation of human medicines unilaterally approve a drug on a national level.
In the case of Lipobay, the UK was the first Member State to approve the drug. Medicines produced with biotechnology are approved through a Centralised Procedure where the EMEA is directly involved in its approval.
The Pharmacovigilance Working Party, hosted by the EMEA, learned in June 2001 that the risk of muscle breakdown was increased, particularly when Lipobay is used in combination with gemfibrozil. And because the UK was the primary Member State to approve Lipobay, the working party immediately notified the UK’s Medicines Control Agency that the Bayer’s Lipobay needed to upgrade their health warning labels. Bayer immediately changed Lipobay’s labels in Europe.
The German Federal Department for Health will publish an analysis on 16 August 2001 that should reveal possible flaws during the approval procedure of Lipobay.
On August 8, Bayer voluntarily withdrew Lipobay, the world's fourth largest selling anticholesterol drug, after reports linking it to the deaths of 52 patients taking the drug worldwide. One day later, the European Medicines Evaluation Agency (EMEA) announced that an advisory panel would conduct a safety review of statins. Statins have been linked to rare reports of severe muscle reaction. In the case of Bayer's Lipobay, fatal cases have been much more frequent. In addition, problems with the drug occur more frequently when it is taken in conjunction with another drug called gemfibrozil or in high dosages.
The Pharmacovigilance Working Party, the EU's pharmaceutical safety watchdog, is co-ordinating the review to see if problems associated with statins are more widespread. The investigation will focus on whether or not more stringent labelling and dosage restrictions are necessary.