What is Dolobid?
Dolobid is a nonsteroidal anti-inflammatory drug (NSAID) that is used to relieve mild to moderate pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis. Dolobid was approved by the U.S. Food and Drug Administration (FDA) in April 1982.
What's the Problem?
Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are severe skin reactions that have been linked to the use of NSAIDs like Dolobid. SJS and TEN involve the detachment of skin and mucosal membranes that result in painful blistering skin rashes.
Stevens-Johnson Syndrome Symptoms
Typical symptoms for SJS and TEN include peeling skin, fever, body aches, a flat red rash, and blisters and sores on the mucous membranes. Skin peeling is the primary symptom of both conditions. The skin peeling involves the entire top layer of the skin (the epidermis), which sometimes peels off in sheets from large areas of the body.
Related Article: Stevens-Johnson Syndrome Lawsuit
Adverse Skin Reactions Linked to NSAIDs: Study
A 2010 study published in the American Journal of Health-System Pharmacy [1.] looked at the rates of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis associated with the use of NSAID anti-inflammatory drugs.
The study's authors searched the available medical literature to identify studies and cases of SJS and TEN linked to NSAIDs and cyclooxygenase-2-selective NSAIDs. Several epidemiologic studies, case reports, and case series involving the conditions were found. Of the available NSAIDs, oxicam derivatives appeared to have the greatest association with SJS and TEN.
The researchers concluded that the risk of SJS or TEN caused by NSAIDs is extremely low (less than 2 per 1 million users per week for oxicam derivatives, less than 1 per 1 million users per week for other NSAIDs, and 6 cases per 1 million person-years for celecoxib). Older patients, women, and patients within the first month of treatment with NSAIDs appear to have the greatest risk of developing the conditions.
Clinical Characteristics of Drug-Induced SJS/TEN: Study
An April 2022 study published in the journal Asia Pacific Allergy [2.] investigated the differences in clinical characteristics of drug-induced SJS/TEN depending on the type of drug in a single center at Pusan National University Hospital from 2008 to 2019.
The cohort included a total of 92 patients with a mean age of 58.7 ± 20.2 years. Those aged 60-80 years accounted for the largest number of patients (42.4%). Patients with drug-induced SJS/TEN comprised 40 women (43.5%) and 52 men (56.5%).
The researchers categorized drug-induced SJS/TEN cases by culprit drugs into 6 groups: antibiotics, allopurinol, antiepileptic (AED), NSAIDs, acetaminophen, and other drugs.
The rate of NSAID-induced disease significantly increased from SJS to TEN (p = 0.016), the study found. Among the patients in the NSAID group, the proportion of TEN (40%) was higher than that in the other groups (p = 0.021). The mean body surface area was significantly lower in the AED group than in the non-AED groups (7.1 ± 9.8 vs. 23.1 ± 27.3, p = 0.020) and higher in the NSAID group than in the non-NSAID groups (47.5 ± 39.5 vs. 15.7 ± 20.0, p = 0.010).
The study's authors concluded that the clinical characteristics of each causative drug group may be different in drug-induced SJS/TEN. Their findings were intended to help clinicians better understand drug-induced SJS/TEN.
What's the Difference Between SJS and TEN?
Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were first described in 1922 and 1956, respectively. Originally thought to be different diseases, both SJS and TEN are now considered part of the same spectrum, differing only in their severities. SJS affects nearly 10% of body surface area, TEN affects over 30%, and SJS/TEN overlap affects 10-30%.
Other Causes of Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis
In addition to being caused by medications like Dolobid, SJS / TEN may occur as a result of a bacterial infection, vaccination, or graft-versus-host disease. In some cases, a cause cannot be identified. In children with Stevens-Johnson syndrome, infections are the most likely cause.
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Get a Free Dolobid 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 Dolobid 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 Dolobid, 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.