Common OTR Painkillers May Cause Stevens-Johnson Syndrome
Stevens-Johnson Syndrome (SJS) is a skin disorder associated with the use of a variety of medications, including Tylenol and Motrin, which have the active ingredient of acetaminophen. Acetaminophen is a common active ingredient to treat pain and reduce fever, included in many prescription and over-the-counter (OTC) drug products.
Both Tylenol and Motrin may cause severe allergic reactions that affect skin and mucous membranes, triggering severe burning and blistering of tissue. In the most serious cases, blindness and death may occur.
A search of the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System uncovered over 100 severe cases, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products; the cases were categorized as either probable or possible cases associated with acetaminophen.
Joe Lyon is a highly-rated Cincinnati personal injury lawyer and Ohio pharmaceutical attorney representing plaintiffs nationwide in a wide variety of toxic tort and product liability claims.
Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are both life-threatening skin reactions that can result in death. They are medical emergencies that usually require hospitalization.
The conditions usually begin with flu-like symptoms, followed by rash, blistering, and detachment of the upper surface of the skin. While much is still unknown, specialists believe the diseases are caused by allergic reactions to common medications such as Tylenol and Motrin.
As the condition progresses untreated, symptoms can increase and worsen over time. Such signs and symptoms include:
• Mouth ulcers
• Swollen eyelids
• Flu-like symptoms
Further complications can include:
• Permanent blindness
• Dry-eye syndrome
• Lung damage
• Chronic obstructive pulmonary disease (COPD)
• Permanent loss of nail beds
• Scarring of the esophagus and other mucous membranes
• Chronic fatigue syndrome.
Because many physicians and medical personnel are not familiar with the symptoms, treatment of SJS is frequently delayed, worsening the condition. Severe cases may lead to serious health consequences. SJS can cause blindness and results in death in up to 30 percent of severe cases.
A serious skin reaction can occur at any time, even if you’ve taken acetaminophen (Tylenol or Motrin) previously without a problem. There is currently no way of predicting who might be at higher risk. These reactions can occur with first-time use of acetaminophen.
According to researchers at the Mayo Clinic Medical Center, about 70 percent of the adult population, or almost 170 million Americans are prescribed at least one drug.
Accounting for approximately 150,000 deaths per year in the U.S., drug reactions are one of the leading causes of death in the United States.
Because less than one percent of adverse drug reactions are reported to the FDA, and although SJS is considered a rare disease, it may be more prevalent than previously thought.
In 2005, the U.S. Food and Drug Administration instructed Johnson & Johnson, the makers of Tylenol, Motrin and other common painkillers to amend the warning labels on their products.
The FDA informed the public that acetaminophen is associated with Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). An FDA senior official stated, “It is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”
Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions.
Perhaps because they are more sensitive to drugs, a large number of Stevens-Johnson victims are children. In one devastating case, a family was awarded $63 million after a young girl was left permanently blind. Plaintiffs said the condition was directly caused by Motrin.
The jury determined that Johnson & Johnson failed to provide sufficient warnings about the serious side effects of Motrin. In fact, as of 2003, the over-the-counter medication for children contained no warning at all.
Johnson & Johnson has also been found liable in other major Motrin-related cases. In 2011, a California jury awarded a $48 million judgment, and in Philadelphia a court awarded $10 million to the family of a young victim.
If you or a loved one has suffered an injury caused by Tylenol or Motrin use, you may be able to seek compensation from a chemical or pharmaceutical company to help cover the resulting expenses. If you have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.