The Bextra Time Bomb: Side Effects and Litigation Issues
Bextra, a prescription painkiller and anti-inflammatory, has been described by a prominent physician involved in conducting a recent study of the drug, as a “time bomb waiting to go off.”
Dr. Garret A. Fitzgerald, University of Pennsylvania cardiologist and pharmacologist participated in a double-blind study of the popular drug, which found that use of Bextra doubled patients chances of having a heart attack or stroke while on the medication.
Bextra is the brand name for a drug called Valdecoxib, manufactered by G.D. Searle and Pfizer. A popular painkilling and anti-swelling drug, Bextra was frequently prescribed to patients suffering from osteoarthritis, adult rheumatoid arthritis, and dysmenorrhea.
Studies and anecdotal data have thus far linked Bextra use to the following serious and frequently fatal conditions, among others:
- Heart attack
- Stroke
- Angina
- Stevens Johnson Syndrome
- Toxic epidermal necrolysis
Bextra Pulled From US Market
In part as a result of the study showing dangerous increases in cardiovascular problems, Bextra was pulled out of the US market in April 2005 at the request of the Food and Drug Administration (FDA). In the same request, the FDA also called for strongly worded black box warnings for other nonsteroidal anti-inflammatory drugs (NSAIDS), all of which carry similar cardiovascular risks.
The decision to pull Bextra from the market rather than simply requiring stronger warnings, however, was as a response to the additional risk, unique among this class of painkiller, of serious and even fatal skin reactions, including the conditions Stevens Johnson Syndrome (SJS), erythema multiforme (EM), and toxic epidermal necrolysis (TEN).
Both Stevens Johnson Syndrome and toxic epidermal necrolysis are severe allergic skin reactions that cause lesions and inflammation on the skin, eyes, mouth, and internal organs, often leading to organ failure, permanent skin damage, and extensive scarring. As many as 15 percent of cases of Stevens Johnson Syndrome ultimately prove fatal. A larger percentage, as many as 27 percent of cases, result in permanent or long term damage to the eyes, and vision loss.
Further, despite the increased risks, studies showed that Bextra was no more effective and produced no additional benefits over other, less dangerous medications prescribed for the same conditions. Although all COX-2 inhibitor drugs are shown to carry serious risks, Bextra has been shown to carry risks that most other similar drugs do not.
What Next?
If you or someone you love was prescribed Bextra for their condition and subsequently suffered from any of the side effects outlined here, or other unexplained medical conditions that could be related, it is important that you seek competent legal advice as soon as possible.
Pfizer and G.D. Searle chose to manufacture and aggressively market a drug that provided no additional benefits over other, similar drugs, but that carried with it additional, and frequently fatal, side effects.
If you have suffered as a result of this decision, you have a right to be compensated for your financial and emotional losses.
Consult with a qualified pharmaceutical injury attorney in your area who has experience dealing with drug company litigation and who can advise you of your rights.
Click here for detailed information on pharmaceutical injury law.
