EU Regulators Affirm Bextra Suspension, Warn About COX-2 Inhibitors

The European Medicines Agency on Monday recommended the continued suspension of Pfizer's COX-2 inhibitor Bextra in the European Union and reiterated warnings about cardiovascular and other risks associated with all drugs in the class, Reuters/Wall Street Journal reports (Reuters/Wall Street Journal, 6/28). Pfizer in April suspended sales of Bextra in the United States and the EU after FDA and European regulators requested the market withdrawal of the medication over potential safety risks related to serious skin reactions (Kaiser Daily Health Policy Report, 4/7). The announcement on Monday concluded European regulators' review of the suspension. The EU's suspension will be reviewed again within one year, during which time Pfizer can provide additional safety data on the drug. At a hearing last week, the E.U.'s Committee for Medicinal Products for Human Use said that additional warnings and contraindications should be added to all COX-2 inhibitors because of cardiovascular risks but said that the increased risk of serious and possibly fatal skin reactions associated with Bextra outweigh the drug's benefits and merit the continued suspension. The committee also took the following actions:

Confirmed a finding in February 2005 that there is an association between duration and dose of Bextra and the likelihood of cardiovascular problems;

Recommended contraindications that COX-2 inhibitors should not be prescribed to patients with established ischaemic heart disease and/or stroke or to patients with peripheral heart disease;

Reinforced warnings to providers to prescribe COX-2 inhibitors with caution to patients with risk factors for heart disease; and

Recommended additional or stronger warnings to providers and patients that serious, sometimes fatal, skin reactions can occur with all COX-2 inhibitors.The committee said that the overall risk-benefit picture for COX-2 inhibitors remains positive if the medications are prescribed in accordance with the recommended contraindications and precautions (Wall Street Journal, 6/28).


European Medicines Agency


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