Bextra – FDA Warns of Severe Skin Reactions and Cardiovascular Risk

On April 7, 2005, Pfizer agreed to withdraw its popular prescription painkiller Bextra from the market. The decision to recall the drug was made at the FDA's request. The FDA stated that risks of the drug, including serious skin reactions and cardiovascular risks, outweighed the benefits of the drug. Pfizer has also announced that it will suspend sales of Bextra in Europe as well. The FDA and manufacturer advise Bextra patients to stop taking Bextra and consult their physicians.

Bextra Warnings:
On December 9, 2004, the Food and Drug Administration (FDA) announced important new information on side effects associated with the use of Bextra, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) which is indicated for the treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). A "boxed" warning will be added to the label, strengthening previous warnings about the risk of life-threatening skin reactions and a new bolded warning against the use of Bextra in patients undergoing coronary artery bypass graft (CABG) surgery.

The new boxed warning in the label states that patients taking Bextra have reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis. These skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur any time during therapy. In a few cases, these reactions have resulted in death. The labeling advises doctors that Bextra should be discontinued at the first appearance of a skin rash, mucosal lesions (such as sores on the inside of the mouth), or any other sign of allergic reactions. The new boxed warning also states that Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions.

As of November 2004, the FDA has received reports of a total of 87 cases in the United States of severe skin reactions in association with Bextra, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. Of these 87 cases, 36 hospitalizations were reported, including 4 deaths. The reported rate of these serious side effects appears to be greater for Bextra than for other COX-2 agents.

In addition to warning of potential serious skin reactions, the new label also highlights new data about cardiovascular risks. A recently-completed study conducted by Pfizer, showed an increased cardiovascular risk in patients treated with Bextra compared to placebo. Observed cardiovascular events included thromboembolic events such as myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung). The bolded warning specifically contraindicates Bextra for treatment of pain immediately following coronary artery bypass graft (CABG) surgery.

February 2005 : Kaiser Permanente Bans Bextra Citing Heart Attack Risk.
The nation's largest non-for-profit managed care provider, Kaiser Permanente, announced that it would stop prescribing Bextra until tests show whether the painkiller is safe. The decision is based on "compelling" evidence of increased heart risks associated with Bextra and a similar drug called Vioxx pulled from the market in September. Kaiser spokeswoman Beverly Hayon said the moratorium, represents the first time the health system's doctors had decided to stop dispensing a drug that was approved by the Food and Drug Administration. Kaiser plans to stop filling new prescriptions for Bextra on Feb. 1 and on March 1 for refills. A Kaiser memo states the moratorium will last at least six months or "until the FDA and/or Pfizer can provide substantiated evidence to support the cardiovascular safety" of Bextra.

The decision is based on numerous studies that raise concerns about the cardiovascular safety of Bextra and other drugs belonging to the same class such as Vioxx. According to Dr. Sharon Levine, who oversees medication usage for Kaiser Permanente, "This is not a drug that saves lives...It's a drug that provides a modest degree of pain relief — no better than Motrin — and the size of the risk, given the benefit provided, did not seem warranted."