The European drugs watchdog, the European Medicines Agency, has recommended the continued suspension of the cyclo-oxygenase-2 inhibitor valdecoxib (Bextra), at the conclusion of its review on the safety of this class of drugs last week. The agency’s Committee for Medicinal Products for Human Use also strengthened its guidance for prescribers and patients and urged the companies that market COX 2 inhibitors in Europe to carefully monitor and assess adverse reactions.
In its deliberations, the committee agreed that the data for the other drugs in the same class—celecoxib, etoricoxib, lumiracoxib, and parecoxib—showed an increased risk of heart attack and stroke, as well as serious skin reactions. But it concluded that the additional risks of serious and potentially fatal skin reactions associated with the use of valdecoxib outweighed its benefits, warranting its continued suspension.
The manufacturer, Pfizer, had already agreed with the agency to withdraw valdecoxib from the European market in April this year as a precautionary measure, pending the outcome of the review. The company also took the same action in the United States at the request of the US Food and Drugs Administration.
The situation will be reassessed in a year’s time. But the decision will only be overturned if Pfizer can supply further safety and other relevant data to the committee. The type of information required had not been specified, said an agency spokesperson.
In February, the committee found a link between cardiovascular risk and dose and duration of use of COX 2 inhibitor, and advised doctors to treat patients with the shortest course at the lowest possible dose. This month it reiterated that healthcare professionals should exercise caution when prescribing COX 2 inhibitors to patients with known risk factors for heart disease and should not prescribe them to patients with established cardiovascular disease. And it warned that patients with a history of drug allergies may be at particular risk of serious skin reactions.
The European Commission called for the wholesale review of COX 2 inhibitors after the worldwide withdrawal of rofecoxib (Vioxx) in September 2004, because of its cardiovascular risk profile. The European Medicines Agency had last reviewed COX 2 inhibitors in 2003. The commission has now asked the committee to look into the safety profile of conventional non-steroidal anti-inflammatory drugs, after information gleaned during the course of the COX 2 inhibitor review. This is expected to start later this year, but might not necessarily become a full review, said an agency spokesperson.
The agency’s Pharmacovigilance Working Party has already begun a review of the safety of the most commonly prescribed drugs in this class.