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drug_recall bextraBextra risk factors include a number of adverse health events that can be caused by this prescription drug. Bextra risk factors include serious skin and cardiovascular complications. Pfizer, the makers of this prescription medication, have known about various Bextra risk factors for years, yet have negligently failed to take the steps necessary to adequately inform and properly protect consumers from Bextra risks.
Bextra, or valdecoxib, is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID). The FDA approved Bextra in November of 2001 to treat patients with osteoarthritis, rheumatoid arthritis, menstrual cramps, and other pain conditions. FDA approval was based on three to six month long clinical trials that did not find any significant Bextra risk associated with this drug’s use. Unfortunately several Bextra risks have been discovered since the FDA approved Bextra.
A Bextra risk that has received a lot of attention in the medical community is the skin related side effects caused by Bextra. Bextra use has been shown to cause Stevens Johnson syndrome and toxic epidermal necrolysis. Stevens Johnson syndrome is a severe inflammatory skin condition which causes the skin and mucous membranes to erupt. Toxic epidermal necrolysis is a syndrome in which the skin becomes extremely red, blisters, and peels off like a second degree burn would.
In response to this serious Bextra risk, the FDA has requested that Pfizer add a black label warning to all Bextra patient product information. A black box warning is the strongest warning that the FDA can mandate short of recalling a defective drug. The black box Bextra risk warning was order by the FDA in 2002, yet Pfizer failed to comply with their request.
In addition to skin related Bextra risk factors, clinical studies have also found that people who take Bextra risk suffering life threatening cardiovascular side effects. In one study, cardiac bypass surgery patients taking Bextra were two times more likely to suffer a heart attack, stroke, or similar adverse event compared to surgery patients in the control group. Pfizer announced this serious Bextra risk publicly in late 2004, yet the pharmaceutical giant has done nothing to adequately protect patients from serious Bextra risks.
Since the discovery of these life threatening Bextra risks, a “boxed” warning has been added to patient product information. This warning describes the life threatening skin and cardiovascular Bextra risks that threaten patient health. Skin related Bextra risks are highest during the first two weeks of treatment but can occur at any time. Cardiovascular Bextra risk factors are also highlighted in the new boxed warning.
Despite Bextra risk warnings, Pfizer has failed to protect patients from the serious side effects associated with their defective product. If you are concerned about Bextra risk factors, or have been injured as a result of Bextra side effects, you may wish to speak with an experienced attorney who can advise you of your legal rights and options.
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