FDA: Acetaminophen may trigger serious skin problems

摘要

The US Food and Drug Administration (FDA) has added acetaminophen to the list of pain relievers that may in rare cases trigger life-threatening skin reactions. The FDA issued a warning in August that pain and fever reducer acetaminophen may cause Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthema-tous pustulosis (AGEP), conditions that may be fatal, based on a review of the literature and the FDA Adverse Event Reporting System (FAERS) database (http: //1.usa.gov/13fvMbR). These conditions may emerge with flu-like symptoms, a rash, blisters, or shedding of layers of skin after a first or repeat dose of acetaminophen, the agency notes. If an individual experiences such symptoms after taking acetaminophen, the drug should be stopped immediately and medical attention sought. Once a patient has had such a reaction, he or she should never take acetaminophen or acetaminophen-contain ing products again, according to the FDA. These 3 skin conditions are very rare, according to the FDA, but are typically triggered by medication exposure. The agency noted that SJS and TEN are potentially fatal and may require weeks or months of recovery. AGEP is not usually life threatening, but causes the emergence of hundreds of pustules over an area of skin or the whole body; symptoms usually resolve within 2 weeks of stopping medication. Previously, other nonsteroidal anti-inflammatory drugs, including popular painkillers ibuprofen and naproxen, have been linked to serious skin reactions and carry warnings on their labels. The FDA will require makers of prescription acetaminophen products to add a warning to the drugs' labels and will request a similar warning label for over-the-counter products containing acetaminophen.