Group Asks FDA For Ibuprofen Warnings

A group of physicians and families called on US regulators Tuesday to warn the public about a rare but potentially fatal set of skin reactions linked to taking the painkiller ibuprofen. The group filed a petition with the US Food and Drug Administration asking it to strengthen labels on Advil and other ibuprofen-based drugs to warn doctors and consumers that the widely sold products can increase the risk of skin reactions, including serious conditions like Steven Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). SJS occurs in approximately four in every one million ibuprofen users. Those who continue taking the drug can develop TEN, which causes severe skin sloughing and is fatal in nearly one third of affected patients.