In April 2005, Pfizer withdrew the Bextra drug from the market after the FDA asked the pharmaceutical maker to pull the painkiller because the risk of a serious cardiovascular event outweighed Bextra’s potential benefit. The FDA also asked Pfizer to include a black boxed warning, the most serious warning a medication can receive, in the Celebrex label. The government is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular events and gastrointestinal bleeding with their use.
Bextra, also known as valdecoxib, is indicated for the treatment of pain, tenderness and swelling caused by osteoarthritis and adult rheumatoid arthritis. Belonging to a class of nonsteroidal anti-inflammatory medications (NSAIDs) called COX-2 inhibitors, Bextra blocks the action of the COX-2 enzyme, which causes arthritis pain and inflammation. Bextra was approved by the U.S. Food and Drug Administration (FDA) in 2001 and is made by Pharmacia/Pfizer.
Side effects of Bextra use include, but may not be limited to, stomach pain, diarrhea, heartburn, back pain, headache, nausea and upper respiratory infection.
In November 2002, FDA and Pharmacia/Pfizer strengthened the CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS sections of the prescribing information for Bextra. In postmarketing experience, rare reports of hypersensitivity reactions (i.e., anaphylactic reactions and angioedema) and skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme, have been received. These cases, some of which were serious and life threatening, have occurred in patients with and without a history of allergic reactions to sulfonamides.
In October 2004, Pfizer announced that two clinical trials showed heart bypass surgery patients taking Bextra increased their risk of stroke and heart attack. The news came just weeks after the FDA withdrew Vioxx, a similar COX-2 inhibitor, from the market due to an increased risk of cardiovascular events.
In November 2004, researchers presented the results of a study involving Bextra to members of the American Heart Association that showed the COX-2 inhibitor may increase the incidence of heart attacks and strokes. The study, headed by doctors at the University of Pennsylvania, pooled data from over 5,000 patients taking part in dozens of trials. The incidence of heart attacks and strokes among Bextra users was more than double that of those taking a placebo.
In December 2004, the FDA announced important new information on side effects associated with the use of Bextra. A “boxed” warning, strengthening previous warnings about the risk of life-threatening skin reactions, and a new bolded warning contraindicating the use of Bextra in patients undergoing coronary artery bypass graft (CABG) surgery were added to the label.
In January 2005, the results of two trials involving Bextra revealed that the drug triples the incidence of heart attack and stroke in coronary bypass graft surgery patients.
A study conducted by a U.S. private health insurance group has confirmed fears that cox-2 inhibitors cause serious cardiovascular events. In February 2005, Wellpoint Inc. released a study that found Bextra, Celebrex and Vioxx increase the risk of heart attack or stroke in users. According to the research, the risk of heart attack was 53 percent higher than normal for patients taking Bextra, 19 percent higher for those taking Celebrex and 23 percent higher for patients taking Vioxx. The study reportedly found no increase in cardiovascular events in patients taking traditional anti-inflammatory medications.
Concluding three days of meetings reviewing the safety of cox-2 inhibitors, advisers told FDA officials in February 2005 that Celebrex, Bextra and Vioxx, while posing an increased risk for cardiovascular events, should stay on the market because the drugs’ benefits outweigh their potential dangerous side effects. The advisory panel voted 31-1 to keep Celebrex on the market, 17-13 to keep Bextra available to patients and favored Vioxx by a vote of 17-16. Vioxx is currently not for sale after being recalled in September 2004. The FDA does not have to follow the panel’s recommendations but generally does.
See your doctor if you have concerns about the safety of Bextra or if you have experienced serious side effects associated with the drug.
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