What is Remicade?
Remicade (infliximab) is a prescription tumor necrosis factor (TNF) blocker drug that is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and severe or disabling plaque psoriasis in adults. The drug works by reducing the effects of a substance in the body that can cause inflammation. Remicade is manufactured and marketed by Janssen CarePath and was first approved by the U.S. Food and Drug Administration (FDA) on August 24, 1998.
What's the Problem?
Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are severe dermatologic conditions that are caused by an adverse reaction to medications like Remicade. Although it is still unclear exactly how drug interactions lead to SJS/TEN, one theory holds that altered drug metabolism in some patients triggers a T-cell–mediated cytotoxic reaction to drug antigens in keratinocytes.
What is SJS/TEN?
In its early stages, the symptoms of Stevens-Johnson syndrome (SJS) are typically flu-like, including fever, sore throat, fatigue, and eye irritation. As the condition progresses, a red or purplish rash often appears on the skin and begins to spread and blister. This rash causes the outermost layer of skin to die and shed from the body, usually just a matter of days after the rash appears.
Toxic Epidermal Necrolysis is a more advanced, severe, and life-threatening form of Stevens-Johnson syndrome. When more than 30% of the total body surface area is covered in blisters or significant rash, the disease is considered to be Toxic Epidermal Necrolysis. TEN is severe and life-threatening, carrying a mortality rate of 30%-80%.
Related Article: Stevens-Johnson Syndrome Lawsuit
Stevens-Johnson Syndrome Symptoms
- 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.
Identification and early withdrawal of the offending medication is the most important action in caring for patients with Stevens-Johnson syndrome or Toxic Epidermal Necrolysis. Many cases of SJS/TEN require supportive care in a burn intensive care unit, with a focus on assessment and management of the airway, renal function, fluid and electrolyte balance, nutrition, skin and ocular surfaces, pain control, and prevention of infection.
Remicade and Cancer
In 2004, a warning letter was sent to healthcare professionals stating that Remicade had been linked to cases of lymphoma in patients who had taken the medication. A study published in the May 2006 issue of JAMA concluded that Remicade side effects could triple the risk of cancer.
The Food and Drug Administration FDA June 2008 released a statement about an ongoing safety review involving Remicade and its potential link to the development of lymphoma and other cancers in children and young adults. A black box cancer warning was added to the labeling of Remicade in August 2009.
Remicade Fungal Infections
According to the FDA, many patients who took TNF blockers like Remicade subsequently developed fungal infections, such as histoplasmosis, blastomycosis, and coccidioidomycosis. In several of these cases, the infections resulted in the death of the patient.
In Sept. 2008, FDA issued an alert to healthcare providers to provide new information about the risk of fungal infections associated with Remicade. At the time, the agency also indicated that additional information would be added to the Remicade black box warning to ensure that doctors and consumers were aware of the fungal infection risk. Unfortunately, many cases of Remicade fungal infections go undiagnosed, since the symptoms are similar to the flu.
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Get a Free Remicade 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 Remicade 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 Remicade, 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.