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FDA OKs Warning Label For Pfizer's Bextra

Dec 10, 2004 |

The federal Food and Drug Administration approved new labeling Thursday for Pfizer Inc.'s Bextra drug to warn of possible serious skin reactions and heart-related problems for those who've experienced coronary bypass surgery. The federal regulatory agency said a new “black box†warning on the label will state that some patients have reported a serious and potentially fatal skin reaction, which the agency said is most likely to occur in the first two weeks of treatment.

The agency said the label also would add a warning in bold type about possible heart attack, stroke and blood-clot problems in the legs and lungs of those undergoing coronary artery bypass graft surgery.

The FDA uses both its “black box†warnings literally warnings enclosed in a black box on the label and its bold-type warnings to provide health-care professionals and patients with important news about possible side effects of medications.

Bextra is one of Pfizer's two Cox-2 inhibitor drugs, which are used for acute pain and inflammation. Bextra is used primarily for osteoarthritis, rheumatoid arthritis and menstrual pain. In addition to Bextra, Pfizer also manufactures the best-selling Celebrex drug, which also is used for arthritis-related ailments and acute pain and inflammation. The drugs inhibit the Cox-2 enzyme, which causes pain and swelling.

New York-based Pfizer, which has extensive research, development and manufacturing operations in southeastern Connecticut, said that Bextra generated global sales of $869 million through the first nine months of this year, compared to $2.3 billion for Celebrex.

The FDA said that through November, it had recorded 87 cases in the United States of severe skin reactions associated with Bextra. It also said that 20 of those cases involved patients who had a known allergy to sulfa products in drugs. Of those 87 cases involving serious skin reactions, the FDA said 36 patients were hospitalized and four died. The new labeling will inform patients and doctors to stop use of the drug at the first appearance of skin rash, sores inside the mouth or other signs of allergic reaction.

Bextra and Celebrex are considered non-steroidal anti-inflammatory drugs, or NSAIDs. Merck & Co. also manufactured a popular anti-inflammatory drug called Vioxx, which it pulled from the shelves in late September because of increased risks of heart attacks and strokes.

The surrounding controversy over the Vioxx withdrawal and questions over the use of Cox-2 drugs led the FDA to call for hearings in February that will include outside experts testifying about the drug class. Pfizer has welcomed those hearings and has repeatedly said that its Cox-2 drugs have a different composition than Vioxx and do not pose similar problems. Arthritis patients often take the Cox-2 drugs to reduce pain or inflammation because they don't cause the stomach upset or damage that can result from use of over-the-counter medications such as aspirin, ibuprofen and acetaminophen.

The FDA said the new labeling about Bextra's possible side effects with bypass surgery patients was aided by a Pfizer study of 1,500 patients that showed an increased cardiovascular risk after such surgery with Bextra compared to a placebo. FDA officials said the risk was higher with intravenous injections of Bextra compared with patients taking the medication orally.

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