Table Of Contents
- What is Feldene?
- What is Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN)?
- What’s the Difference Between SJS and TEN?
- SJS/TEN Symptoms
- Feldene-Induced TEN: Case Report
- How Do Medications Cause Stevens-Johnson Syndrome?
- How Common are SJS/TEN?
- Watchdog Group Calls on FDA to Ban Feldene
- Get a Free Feldene Stevens-Johnson Syndrome Lawsuit Evaluation With Our Lawyers
What is Feldene?
Feldene is a non-steroidal anti-inflammatory drug (NSAID) that is used to reduce pain, swelling, and joint stiffness from arthritis. The drug works by blocking the body’s production of certain natural substances that cause inflammation. Feldene is manufactured and marketed by Pfizer Inc. and was approved by the U.S. Food and Drug Administration (FDA) in 1982.
What is Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN)?
Stevens-Johnson Syndrome and the related disease toxic epidermal necrolysis are 2 of the most serious adverse reactions linked to NSAID painkillers like Feldene. The conditions are characterized by high fever, malaise, and a rapidly developing, blistering exanthema of macular papules and target-like lesions, accompanied by mucosal involvement.
What’s the Difference Between SJS and TEN?
According to the World Allergy Organizations (WAO) [2.], SJS/TEN are defined by the degree of skin detachment: SJS/TEN is defined as skin involvement of <10 and >30%, respectively, and that of SJS/TEN overlap as 10–30% skin involvement.
- Flu-like symptoms
- High temperature
- Sore throat
- Joint pain
- Rash that usually starts on the upper body before quickly spreading to the face, arms, legs, and other areas of the body, such as the genitals.
Feldene-Induced TEN: Case Report
A 2015 study published in the International Journal of Current Microbiology and Applied Sciences [3.] looked at a case of a 35-year-old male who was hospitalized with complaints of swelling gums, lips, and eyelids, along with throat pain and difficulty swallowing. The patient had a history of ingestion of drugs, including Feldene.
Two days after being admitted to the hospital, the patient developed rashes over his face, neck, chest, and trunk, along with a high-grade fever. Antibiotics were escalated and a dermatology reference was given. The patient was given an IV for 5 days, along with pulse steroid therapy.
He later developed large areas of epidermal detachment with blisters and areas of denuded skin along with severe conjunctivitis, and severe stomatitis with purpuric macules. The patient ultimately died due to extensive exfoliation and septicemia due to TEN induced by Feldene tablet ingestion.
How Do Medications Cause Stevens-Johnson Syndrome?
The precise mechanism of action by which drug use leads to SJS/TEN is still not yet fully understood, but it is thought to be immune-mediated. The role of the T-cell-mediated immune response in the pathogenesis of SJS/TEN has been firmly established.
Specifically, the human leukocyte antigen (HLA) system seems to play a fundamental role in the emergence of SJS/TEN, as some medications bind directly to the HLA-complex and cause self-reactivity due to the drug-modified HLA-peptide repertoire. There are numerous reports linking HLA alleles to SJS/TEN.
How Common are SJS/TEN?
SJS/TEN are rare but life-threatening severe cutaneous adverse reactions. The conditions occur in all ages, races, and sexes, with incidences ranging from 0.4 to 1.2 and 1.2 to 6 per million person-years. A USA-based study analyzing nationwide inpatient records from 2009 to 2012 calculated an incidence per million inhabitants of 8.61–9.69 for SJS, 1.46–1.84 for SJS/TEN overlap, and 1.58–2.26 for TEN.
Watchdog Group Calls on FDA to Ban Feldene
In 1995, the Public Citizen Health Research Group asked the FDA to take Feldene off the market, according to the Washington Post [1.].
“We think that no one should be on this drug in the country,” said Sidney M. Wolfe, director of Public Citizen. Wolfe said Feldene has the potential to create severe bleeding problems in the stomach and intestinal tract, as well as damage to the kidneys.
Public Citizen had been campaigning against Feldene since 1986. The group said that the medicine was an “imminent hazard to the public health” and urged the FDA to ban prescriptions of Feldene to people aged 60 and older, who are most at risk for severe side effects.
- Daypro Stevens-Johnson Syndrome Lawsuit
- Dolobid Stevens-Johnson Syndrome Attorney
- Diflucan Stevens-Johnson Syndrome Lawsuit
See all related dangerous drug lawsuits our attorneys covered so far.
Get a Free Feldene Stevens-Johnson Syndrome Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Feldene 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 Feldene, 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.