FDA call for added labeling on OTC pain relievers

The US Food and Drug Administration issued a final rule that requires manufacturers of over-the-counter pain relievers and fever reducers to  revise their labeling to include warnings about potential safety risks,  such as internal bleeding and liver damage, associated with the use of  these popular drugs.

Products covered by the FDA action include acetaminophen, and a class  of drugs known as the nonsteroidal anti-inflammatory drugs. NSAIDs  include aspirin, ibuprofen, naproxen and ketoprofen. Acetaminophen is in  a class by itself. The revised labeling applies to all OTC pain  relievers and fever reducers, including those that contain one of these  ingredients in combination with other ingredients, such as in cold  medicines containing pain relievers or fever reducers.

"Acetaminophen and NSAIDs are commonly used drugs for both children and  adults because they are effective in reducing fevers and relieving minor  aches and pain, such as headaches and muscle aches," said Charles  Ganley, Director of the FDA's Office of Non-prescription Drugs in the  Center for Drug Evaluation and Research. "However, the risks associated  with their use need to be clearly identified on the label so that  consumers taking these drugs are fully aware of the potential harm they  can cause. It is important that they know how to take these medications  safely to reduce their risk," he added.