Advil, an ibuprofen based medication, is one of the most common drugs associated with Stevens Johnson Syndrome (SJS) in children. SJS is typically an allergic reaction to a drug and can be life-threatening. Advil (Ibuprofen) was approved for public use by the FDA in 1973 and is considered the first non-Aspirin, non-Acetaminophen based non-steroidal anti-inflammatory (NSAID) medication. It is sold under various other brand names including Motrin, Children's Advil, Children's Motrin, Medipren, Nuprin, Pediacare Fever, etc.
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.
Stevens Johnson Syndrome Symptoms
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)
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.