The manufacturers of Bextra and the FDA have issued advisories to doctors about Bextra's potential skin-related side effects since 2002. In November of 2002, the FDA reported that it had received about 20 reports of such skin conditions, including reports of Stevens Johnson Syndrome and toxic epidermal necrolysis. Recently, more serious warnings have been issued, leading to Bextra receiving a "black box" label for risk factor for causing these severe skin conditions.
Stevens Johnson Syndrome is a condition which, according to Newsday, "causes the immune system to turn on itself to rid itself of a drug, in effect burning the patient from the inside out." Stevens Johnson Syndrome often involves severe blistering of the mucous membranes and skin. According to WebMD, Stevens Johnson Syndrome:
- Is characterized by inflammation of the mucous membranes of the mouth, throat, genital region, intestinal tract and membrane lining the eyelids (conjunctiva).
- Affected individuals may have abnormalities (lesions) of the skin and mucous membranes that are purplish or red in color. In some cases, the lesions may develop raised fluid-filled centers (blisters). Affected individuals may also have blisters and/or bleeding in the mucous membranes of the lips, eyes, mouth, nasal passage, and genitals.
- Abnormalities of the eyes may develop as a result of the lesions caused by Stevens-Johnson Syndrome (ocular sequelae). Such abnormalities may include infection of the delicate membrane of the eye and eyelids (conjunctiva) and inflammation associated with an abnormal discharge from the conjunctiva (purulent conjunctivitis).
These conditions can have severe, and sometimes fatal, consequences. Difficulty with breathing, urination and respiratory failure are possible results of Stevens Johnson Syndrome, which has a mortality rate of 30%.
Toxic epidermal necrolysis can result in even more serious consequences, including blisters that meld into one another to cover a substantial portion of the body (30% and more), and extensive peeling or sloughing off of the skin.
Other consequences from these conditions include permanent skin and organ damage (including extensive scarring), secondary infections of the skin and organs and even vision loss, both partial and complete.
In the wake of Vioxx's removal from the marketplace in September 2004, Bextra came under increased scrutiny. Pfizer issued a warning to doctors on October 15, 2004, stating that not only did Bextra cause severe skin-related side effects such as Stevens Johnson Syndrome, but it did so more often than any other COX-2 inhibitor. In addition, Pfizer warned that the risk of developing these conditions was greatest within the first two weeks of using Bextra.
On December 9, 2004, the FDA announced that Bextra would carry a "black box" label to warn consumers and doctors of the risk of potentially fatal skin reactions. A "black box" label is the strongest warning the FDA can give without actually recalling a drug from the marketplace. WebMD has stated that, "As of November 2004, the FDA had received reports of 87 cases in the U.S. of severe skin reactions in association with Bextra of these 87 cases, four died."
Although Bextra is now thought to cause dangers similar to Vioxx and Celebrex, Pfizer has not recalled Bextra from the market. However, those who have taken Bextra and suffered skin reactions like Stevens Johnson Syndrome or severe coronary events such as strokes or heart attacks, or their families if the coronary event resulted in death, may have legal options to recover for damages.
It now appears that the side effects caused by the entire class of drugs to which Bextra, Celebrex and Vioxx belong, COX-2 inhibitors, may be far worse than any potential benefit. In fact, no study ever showed that the COX-2 inhibitors offer significantly better relief than the traditional NSAID family of drugs that includes aspirin, ibuprofen, and naproxen.
With the FDA's recent actions on Vioxx, many experts believe it is only a matter of time before more serious efforts are taken to protect patients from Bextra's dangers. As the FDA's own David Graham stated in late December:
"The FDA is saying they can't be sure these drugs are safe. Well, if they're concerned, perhaps people shouldn't be using [the drugs] at all."
If you or a loved one have taken Bextra and have experienced any side effects, including blood clots, heart attacks, strokes, sudden death or severe skin reactions, contact us immediately at 800-966-4999 and see why our law firm has recovered over $100 million on behalf of our clients.
