What is Motrin?
Motrin (generic: ibuprofen) is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain in the body. The medication is used to reduce fever and treat pain or inflammation associated with many conditions such as headache, toothache, back pain, arthritis, menstrual cramps and minor injuries. Motrin is manufactured by Johnson & Johnson.
What’s the Problem?
Lawsuits are being filed against J&J for failing to adequately warn consumers that Motrin can increase the risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), severe skin reactions that cause rash, skin peeling, and sores on the mucous membranes.
FDA Ibuprofen Warning
In May 2006, the FDA announced that a number of OTC and prescription medications would have their labeling updated to include a warning about Stevens-Johnson syndrome. Drugs affected by this action included Motrin, Children’s Motrin, Advil Migraine, Advil Liqui-Gels, Advil Cold & Sinus, and Tolectin.
- Facial swelling
- Tongue swelling
- Skin pain
- A red or purple skin rash that spreads within hours to days
- Blisters on your skin and the mucous membranes of your mouth, nose, eyes and genitals
- Shedding of your skin
Motrin SJS Lawsuits
- A 2008 lawsuit filed by Christopher Trejo of Los Angeles, CA., claimed that J&J failed to provide adequate warning in October 2005, when he was 15 and developed SJS/TEN after taking OTC Motrin. The California Court of Appeal ruled that Trejo’s case could go forward on the issue of “failure to provide adequate warnings of SJS and Tens.” A jury awarded Trejo $48 million in damages in September 2011.
- In February 2013, the family of a 7-year-old girl who nearly died and was left legally blind after taking Children’s Motrin was awarded $63 million by a Massachusetts jury that found Johnson & Johnson failed to adequately warn of the drug’s potential side effects. Samantha Reckis was given Children’s Motrin after showing signs of fever around Thanksgiving in 2003. However, her condition worsened as she continued to take the drug, and within days she was diagnosed with toxic epidermal necrosis. The condition left Reckis with severe respiratory damage, blindness and the loss of 90% of her skin.
- In July 2014, a jury awarded the family of Brianna Maya $10 million in damages after it was found that she was severely injured by SJS after taking Motrin. Maya was just 3-years-old in 2000, when her parents gave her Children’s Motrin and Children’s Tylenol to treat a cough and fever, at the recommendation of their pediatrician. Within days, Maya developed a rash all over her body and redness in her eyes. She ultimately lost 84% of her skin, suffered brain damage, and went blind in one eye.
SJS and TEN require hospitalization, typically in an intensive care or burn unit. The first step in treating the conditions is to discontinue use of offending medications (such as Motrin). A combination of supportive care and prescription drugs will then be administered to nurse the patient back to health.
Which Other Drugs Have Been Linked to SJS/TEN?
In addition to Motrin, other medications that have been linked to Stevens-Johnson syndrome and/or toxic epidermal necrolysis include:
- Sulfa-based medications
- Any other NSAIDS or ibuprofen-containing drugs
New Regulations to Improve Safety Reporting in Clinical Trials
In June 2011, the New England Journal of Medicine (NEJM) reported that the FDA had published a regulation establishing a new safety-reporting paradigm for medications for the purpose of improving consumer protection. Researchers have acknowledged that not only are SJS and TEN severe and unexpected allergic reactions, but also strongly correlated with Motrin and many other common household medications.
1974 – Approved by the FDA
Prescription Motrin first approved by the FDA.
1984 – Approved for OTC use
Ibuprofen becomes first NSAID approved for OTC use.
May 2006 – Product labeling updated
FDA orders manufacturers of Motrin and other ibuprofen-containing medications to update their product labeling with an SJS warning.
2009 – Warning added
SJS/TEN warning added to the labeling of OTC Motrin.
2011 – New protocol established
July 7, 2011 – FDA establishes new protocol to improve safety reporting in clinical trials.
2011 – $48 million awarded
September 2011 – $48 million awarded to a Christopher Trejo, a man who used Motrin as a teenager in October 2005 and developed TEN.
2013 – Jury awards $63 million
February 13, 2013 – Massachusetts jury awards $63 million to the family of a girl who developed toxic epidermal necrosis after taking Children’s Motrin.
2014 – $10 million in damages awarded
July 2014 – Family of Brianna Maya awarded $10 million in damages after it was found that she was severely injured by SJS after taking Children’s Motrin.
- “Stevens-Johnson Syndrome Symptoms”. Mayo Clinic. April 22, 2014.
- “Family awarded $63 million in Motrin case”. Boston Globe. February 13, 2013.
- “New FDA Regulation to Improve Safety Reporting in Clinical Trials”. New England Journal of Medicine (NEJM). July 7, 2011.
- “Motrin Lawsuit: Jury Awards Girl $10 Million for Burns and Blindness”. ABC News. June 3, 2011.
- “Docket No. 2005P-0072/CP1”. U.S. Department of Health and Human Services. June 22, 2006.
- “Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)”. Merck Manual.