What is Bextra?
Bextra was a popular NSAID medication that was used to relieve the symptoms of osteoarthritis and adult rheumatoid arthritis and for the treatment of primary dysmenorrhea (painful menstruation). The drug was manufactured by Pfizer Inc. and was approved by the U.S. Food and Drug Administration (FDA) in November 2001.
Related Article: Stevens-Johnson Syndrome Lawsuit Update
Study Analyzes SJS Following NSAID Treatment
A May 2022 study published in Frontiers in Pediatrics [2.] sought to clarify the specific differences in the adverse effects of skin and mucosal invasion associated with non-steroidal anti-inflammatory drug treatment.
For the study, the researchers data-mined the suspected incidences of SJS linked to NSAID use in the FDA's Adverse Event Reporting System (FAERS) from January 2004 to March 2021. They identified a total of 1,868 reports of SJS associated with NSAIDs.
Among 5 NSAIDs studied (acetaminophen, ibuprofen, aspirin, diclofenac, and celecoxib), ibuprofen had the strongest link to SJS based on the reporting odds ratio (ROR = 7.06, 95% two-sided CI = 6.59–7.56). However, ibuprofen-associated SJS also had the lowest fatality rate (6.87%, p < 0.0001) and the highest hospitalization rate (79.27%, p < 0.0001).
Celecoxib-associated SJS had the latest time to onset (317.56 days, p < 0.0001). Diclofenac-associated SJS cases were linked to the highest risk of death (25.00%, p < 0.0001).
The authors concluded that the analysis of FAERS data provides a more accurate profile of the incidence and prognosis of SJS after NSAID treatment, enabling continued surveillance and timely intervention in patients at risk of SJS following the use of NSAIDs.
Symptoms of SJS
- Flu-like symptoms
- High temperature
- Sore throat
- Joint pain
- Rash usually starts on the upper body before quickly spreading to the face, arms, legs, and other areas of the body, such as the genitals.
Bextra was recalled at the request of the FDA in April 2005 after it was determined that the risks of taking the drug outweighed the benefits after studies linked it to an increased risk of Stevens-Johnson syndrome (SJS)/
Toxic Epidermal Necrolysis (TEN), heart attacks, strokes, and other life-threatening cardiovascular side effects.
Study Links Bextra to Adverse Skin Reactions Separate from SJS/TEN
In June 2007, a study published in the Archives of Dermatology [1.] analyzed a series of unusual skin reactions linked to treatment with valdecoxib (the active ingredient in Bextra). The researchers looked at 5 cases of suspected Stevens-Johnson syndrome in patients who took valdecoxib after the drug was recalled in April 2005.
A review of the skin reactions found extensive erythematous, target-like skin eruptions, facial edema, and dyspnea. Histologic changes, clinical patterns, and outcomes demonstrated a distinct entity from SJS/TEN, the study found.
The researchers concluded that valdecoxib induces severe skin reactions different from those of SJS and TEN in clinical and histopathologic findings, course, and outcome.
When was SJS First Observed?
Stevens-Johnson syndrome was first described in 1922 by pediatricians A. M. Stevens and F. C. Johnson, who reported 2 cases of children who presented with a febrile, mucocutaneous eruption of a presumed infectious etiology.
The boys lived in different areas, and there was no evidence that they had any previous contact with one another. However, their symptoms, which included high fever, eye and mouth discharge, and seasonal presentation, made Stevens and Johnson suspect an infectious cause.
Both children eventually went blind from the condition (one totally and the other partially), but recovered with supportive care. Stevens and Johnson initially misdiagnosed the boys as having hemorrhagic measles or “black measles,” until the doctors recognized that the symptoms were unique and constituted a new entity.
Are There Other Names for Stevens-Johnson Syndrome?
Stevens-Johnson Syndrome is also commonly known as Lyell’s syndrome, SJS/TEN, and Stevens-Johnson syndrome toxic epidermal necrolysis spectrum. It may also be referred to as drug-induced Stevens-Johnson syndrome or mycoplasma-induced Stevens-Johnson syndrome if the condition is associated with a specific cause.
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Get a Free Bextra Stevens-Johnson Syndrome Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group Schmidt & Clark, LLP our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Bextra Stevens-Johnson Syndrome lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Again, if you or a loved one was diagnosed with Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) after taking Bextra, you should contact our law firm immediately for a free case review. You may be entitled to compensation by filing a suit for legal fees and our defective drug lawyers can help with a free case evaluation.