Black Box Warning from the FDA
FDA Medication Guide for NSAIDs
SJS/TEN and NSAID's
Non-steroidal anti-inflammatory pain drugs, NSAID's, are some of the most prescribed medications, and in general are used to relieve pain and inflammation. They are also available in many over-the-counter medications containing Ibuprofen such as Advil Cold and Sinus, Advil Cold, Advil Allergy Sinus, Children’s Advil Allergy Sinus, Ibuprofen Cold and Sinus, Sine-Aid IB, and Children's Motrin Cold.
Based on the citizen repetition submitted in February, 2005, the Food and Drug Administration (FDA) has directed drug manufacturers to make labeling changes to Ibuprofen and other non-steroidal anti-inflammatory drugs that include additional warnings regarding the risks of Stevens - Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).
We tirelessly supported the citizen petition filed with the FDA to make the public aware of the possible risks related to these drugs and SJS/TEN.
In addition to the labeling changes for NSAID's, the FDA has published a user-friendly Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on their website. This FDA document lists life-threatening skin reactions as one of the possible serious side effects of NSAIDs.
The document is available on the FDA website in HTML and PDF format at: