FDA Requires Changes to Fentanyl Pain Patch Warnings

To reduce the risk of accidental exposure, FDA has announced new requirements that change the appearance of fentanyl pain patch warnings to make them more visible. The change will also require new language in the warning that emphasizes the risk of death from accidental exposure, particularly in children. The announcement coincided with a Consumer Update that stressed the potential danger of improperly discarded fentanyl patches to children and pets. FDA reminded consumers of the agency’s previous advice for securely storing unused patches and disposing of used fentanyl patches by folding the sticky sides together and then flushing them down the toilet. The agency also advises patients to cover in-use patches with an adhesive film to keep them from coming loose, and to regularly check patches to ensure they are securely in place. FDA offers additional information for health care providers on the “Fentanyl Transdermal System (marketed as Duragesic) Information” page. (Source: NABP e-News)
http://www.fda.gov/Drugs/DrugSafety/ucm368902.htm