Bextra Label to Include Warning on Heart Attack Risk, FDA Says

by Mario Lozano on December 9, 2004 · 1 comment

in Bextra

The “Powerful” arthritis drug Bextra from Pfizer will include a new warning about possible heart attack risk when used by patients who recently had heart bypass surgery, the Food and Drug Administration said on Thursday.

Bextra is part of the same family of drugs, COX-2 selective non-steroidal anti-inflammatory drug (NSAID), as Celebrex also made by Pfizer and Vioxx, which was withdrawn on September 30, 2004 by Merck & Company after a study confirmed that Vioxx increases a patients’ risk of heart attack and stroke after 18 months of use.

The new “boxed” warning will stregthen previous warnings about the risk of life-threatening skin reactions, and include a new warning about possible heart attack, srtoke, deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung) when used by patients who have just had coronary artery bypass graft (CABG) surgery.

Boxed and bolded warnings provide healthcare professionals and patients with important information on drugs that may be associated with serious side effects in a way that maximizes the drug’s benefits and minimizes its risks, the FDA said.

(via U.S. Food and Drug Administration)

{ 1 comment }

1 Anna W. Jones December 30, 2004 at 7:42 am

I sufferred an acute MI after taking Bextra for 2 years. I am 51 years old.

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