Doctors want stronger warning on ibuprofen bottles; group tells FDA the painkiller can cause serious skin reactions

• 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).
• Three families that are suing drug companies, alleging that their children were injured or killed after using ibuprofen, also signed the document.
• The petition also calls on the FDA to launch an investigation into allegations that ibuprofen manufacturers withheld information on the risks of dangerous reactions to their products.
• Ibuprofen does not generally cause the disorder in adults but can in children, said Dr. Roger E. Salisbury, a professor of surgery at Westchester Medical Center in Valhalla, New York, who also signed the petition.
• Some ibuprofen products marketed in Europe carry label warnings of rare severe skin reactions, though their American counterparts do not, the group said.
• "We're merely asking the FDA to look at this and tighten up the warnings," Salisbury said.
• "If my doctor and my husband and I had known about these risks of SJS and TEN we would have never given her Children's Advil," said Darlene Kiss, who sued Advil maker Wyeth Consumer Healthcare last month alleging that the drug caused the death of her 3-year-old daughter Heather in March 2003.
• McNeil Consumer & Specialty Products, a division of Johnson & Johnson that markets several child and adult forms of ibuprofen under the brand name Motrin, issued a statement stressing that SJS is rare and can have a variety causes.