17/08/2001 (Agence Europe) - In a note on the affair of the withdrawal by Bayer of cerivastatin-based anti-cholesterol medicines, said to be responsible for several deaths (see yesterday's EUROPE, p.1), the European Commission stipulates that, in June, the early warning system provided for by the European Agency for the Evaluation of Medicines was triggered in time. Indeed, it was at the request of the European "Pharmacovigilance" working party, created within the Agency, that Bayer had urgently imposed restrictions on the use of this type of medicine. At the time, Bayer had not indicated the existence of an increased risk that would have justified the withdrawal of the product from the market, says the note. And, noting that European legislation demands of pharmaceutical companies a "proactive approach" in this field, it stresses that the fact of "not communicating new information is a serious matter". The note also recalls that Member States had authorised cerivastatin on the basis of the mutual recognition procedure, and that the primary responsibility for the follow-up of any new information rests with the Member States.