Ibuprofen found immediate popularity with Physicians and the general public when it was approved for over-the-counter (OTC) sales in the United States. In many cases it exhibits the milder stomach effects of Acetaminophen (over Aspirin, a powerful stomach irritant) without as much liver and kidney toxicity, supposedly allowing for higher dosing and longer use.
Stevens Johnson Syndrome and Toxic Epidermal Necrosis (SJS/TENS) are serious and life threatening skin disorders believed by many to be the result of an adverse reaction to drugs, including NSAID medications including Ibuprofen, Cox-2 Inhibitors and others. While viral infections and some forms of cancer can also cause the condition, the Stevens Johnson Syndrome Foundation states that the leading cause of SJS/TENS can be traced back to adverse drug reactions.
The symptoms of SJS/TENS include painful blistering of the skin and mucous membranes, which in many cases is preceded with flu-like symptoms and a high fever. As it evolves, the skin can literally slough off the victim's body. In addition, it tends to affect the eyes with mild to severe conjunctivitis, all the way up to severe corneal perforations. Left untreated, SJS/TENS is life threatening. In many cases, SJS/TENS patients are treated in Intensive Care Units and in Burn Units.
Stevens Johnson Syndrome Symptoms
In February 2005 a group of physicians and victim's families called on the FDA to warn the public about the potentially fatal skin condition associated with Advil and other Ibuprofen based formulations. About four in every one million users develop the condition and Ibuprofen remains one of the most popular and regularly available OTC painkiller/NSAIDS in the world today, used by billions of people worldwide. Reports of SJS/TEN reactions due to Ibuprofen have been increasing, according to the FDA's Medwatch Program.
Advil Ibuprofen SJS FDA Warning
Many Ibuprofen medications are sold with no warning about the potential for SJS/TENS. In fact, most, like Children's Advil, did not contain any label warning until May 2006. Currently, SJS warnings are required on prescription-strength ibuprofen and other prescription drugs linked to SJS, but the FDA has not yet required ibuprofen drug manufacturers, such as Wyeth, the maker of over-the-counter Children’s Advil, to include the life-threatening disease or its symptoms on non-prescription labels.
Many patients took this medication without knowing the potential for this dangerous side effect, and many developed SJS/TENS as a result.
Children's Advil and Children's Motrin are commonly utilized painkillers for children between two and eleven years of age. While this allergic reaction has been reported in adults, it has been noted that there may be a trend where SJS/TENS reactions are increasing in children due to the use of Ibuprofen based pain formulas.
The following Advil medications contain a Stevens Johnson Syndrome warning to parents:
- Children's Advil Suspension
- Children's Advil Cold
- Infants' Advil Concentrated Drops
- Skin reddening
- Facial swelling
- Asthma (wheezing)
A three-year-old girl died in 2003 one week after taking Children’s Advil. In 2005 the parents of Heather Rose Kiss of New Jersey filed a lawsuit against Wyeth, Inc., accusing the health-care giant of accuse Wyeth of wrongful death, negligence, defective design, breach of express warranty, breach of implied warranty, and failure to warn consumers and doctors of the potential health risks—including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)—of taking over the counter (OTC) Children's Advil.
Advil Ibuprofen Lawsuit
The lawsuit further alleges that Wyeth knew of an association with Advil and SJS from their own clinical tests in the late 1980s, but failed to warn physicians and consumers about the increased risks of SJS and TEN. As well, Wyeth documented cases of SJS that occurred in a study to support the approval of the OTC Children's Advil, but failed to disclose this information to physicians or consumers.
Register your Ibuprofen SJS/TENS ComplaintIf you or a loved one has suffered from SJS or TENS, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please click the link below to submit your complaint and we will have a lawyer review your Advil complaint.
Last updated on May-12-14