Bextra to carry new safety warnings in US

pharmafile | December 10, 2004 | News story | |   

Pfizer’s painkiller Bextra will have to carry stronger warnings in the US about increased risk of potentially fatal skin reactions and its contraindication in heart bypass patients.

The drug is in the same  Cox-II inhibitor class as Merck's Vioxx, which was withdrawn in September after new evidence showed it was linked to increased risk of heart attacks and strokes in long-term users.

A storm of controversy has blown up after Vioxx's withdrawal, with the FDA on the defensive about its record on monitoring drug safety and manufacturers forced to reassure doctors and patients that the remaining Cox-IIs are safe.

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The FDA says cases of severe skin reactions to Bextra remain rare, but that the reported rate appears to be greater in the drug compared to other Cox-II's.

The agency also reviewed its contraindication in patients undergoing coronary artery bypass graft (CABG) surgery after Pfizer submitted new data showing increased risk of heart attacks, strokes and blood clots in 1,500 compared to placebo.

Pfizer's other Cox-II Celebrex is the biggest selling drug in the class and has so far escaped concerns about its cardiovascular profile, with a number of recent studies showing no significant risk compared to older treatments.

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