April 7, 2005 Pfizer Inc. has agreed to suspend the sales and marketing of its COX-2 inhibitor painkiller Bextra, at the request of U.S. and European drug regulators, after reports of life threatening side effects.
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Bextra
Bextra Warning
Bextra Side Effects
Bextra and Strokes

Bextra (valdecoxib) is one of three federally approved COX-2 inhibitors that have been used by millions of people worldwide as an arthritis painkiller. Merck & Co. pulled its COX-2 drug Vioxx from the market in September 2004 after an increased risk of heart attacks and strokes were discovered. Following the Vioxx recall, the safety of the remaining two COX-2 drugs, Pfizer Inc.’s Celebrex and Bextra, was also questioned.

In December 2004, data was released linking Celebrex to increased risk of cardiovascular events. By January 2005, data linking Bextra to increased risks for heart attacks and strokes suggested what many safety experts were already saying – that the cardiovascular events were a class wide effect. In a three-day FDA advisory panel meeting in February 2005, the committee ultimately voted to recommend Bextra remains on the market despite associated cardiovascular risks. The panel also recommended Bextra carry a strong warning, which will probably be included in the FDA’s most severe drug warning called a “black box” warning.

In mid-October 2004, Pfizer had sent out a letter to doctors warning them about the serious skin reaction called Stevens-Johnson syndrome, saying it will likely be added as a black box warning to the label. The letter notified doctors about the Bextra side effect, saying the severe skin rashes had led to hospitalizations and deaths.

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Bextra Warning

In January 2005, new data linked Bextra to increased risks for heart attack or stroke. The Bextra warning was the third cardiovascular link made to a COX-2 drug. In September 2004, Merck & Co.’s COX-2 arthritis painkiller Vioxx was recalled after it was shown to cause increased risks of heart attacks and stroke. The Vioxx recall left just two remaining COX-2 drugs on the market – Pfizer Inc.’s Celebrex and Bextra.

In December 2004, data was released showing Celebrex also caused cardiovascular risk. In a rare public hearing, an FDA panel met for three days in February 2005 to determine the benefits and risks of the entire class of drugs, as well as to decide if additional Bextra warnings should be issued. Pfizer had defended its drug after a prominent cardiologist issued Bextra warnings. The panel ended up voting that Bextra should remain on the market despite the cardiovascular risks, noting strong Bextra warnings should be placed on labeling information.

The panel’s vote on Bextra was close, leaving many to wonder how much a Bextra warning will help clear up the confusions.

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Bextra Side Effects

Bextra side effects include potentially deadly cardiovascular events like heart attacks and strokes. In 2004, 12.9 million prescriptions were filled in the United States for Bextra, despite the serious Bextra side effects. Bextra is just one of three federally approved arthritis painkillers belonging to the family of drugs called COX-2 inhibitors.

After a clinical study showed Vioxx, another COX-2 drug, increased the risk of heart attacks and stroke, the drug was pulled off the market. The Vioxx side effects were indicative of a class wide effect, some experts argued, though Pfizer Inc. continued to defend its drug, saying Bextra side effects did not pose the same threat as Vioxx. In January 2005, a prominent cardiologist said a pooled analysis of clinical trial results showed patients taking Bextra were twice as likely to have a heart attack or stroke compared to those patients taking a placebo.

The Bextra side effects were considered so significant that Public Citizen consumer group petitioned the FDA later that month, on January 24, 2005, to immediately remove both Bextra and Pfizer’s other COX-2 drug Celebrex. In conclusion to a three-day FDA panel meeting regarding the safety of COX-2 drugs, the advisory committee voted, narrowly in favor of keeping Bextra on the market while acknowledging cardiovascular Bextra side effects. Bextra side effects warnings will likely be included in a “black box,” the FDA’s most severe drug warning.

Bextra side effects also include the risk of blood clots and a serious skin reaction called Stephens Johnson syndrome.

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Bextra and Strokes

Bextra is part of the controversial class of drugs called COX-2 inhibitors. The family of drugs includes Merck & Co.’s Vioxx and Pfizer Inc.’s Celebrex and Bextra. When a Bextra and strokes connection was made, Vioxx had been recalled from the market just months prior and Celebrex had also been tied to cardiovascular events as well. A prominent cardiologist linked data to increased Bextra and strokes and heart attacks risks in January 2005, which suggested the events were a class wide effect.

In February 2005, in a three-day panel meeting convened to discuss safety issues that surfaced among COX-2 drugs after the Vioxx recall, the advisory committee voted that Bextra should remain on the market despite the Bextra and strokes cardiovascular risks. The vote was close, just barely favoring Bextra’s stay on the market. The panel did not say the drug was safe, however, simply that despite Bextra and strokes cardiovascular risks the drug could continue to remain on the market with strong warnings.

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