Most Americans assume over-the-counter (OTC) painkillers are relatively safe and that dosage limits listed on their labels are mere recommendations, OK to ignore if the pain doesn’t immediately go away. This, unfortunately, is not the case and the US Food and Drug Administration (FDA) is particularly concerned about the risk of liver damage when acetaminophen is taken in excess. The agency will meet with outside advisers in June to discuss the possibility of issuing requirements for stronger warning labels on all forms of acetaminophen, whether sold as a prescription or an OTC medication.
Also under consideration is the possibility of lowering the daily maximum dose for the popular painkiller. Current dose recommendations limit the drug to 4,000 milligrams (mgs) per day for adults but the FDA is calling for a maximum limit of only 3,250 mgs. The agency has also expressed concern about the amount of acetaminophen in immediate-release formulations and dose limits on liquid medicines formulated for children.
Acetaminophen is best known as the active ingredient in the OTC painkiller, Tylenol, but it is available in prescription strength and is often an ingredient in combination products that offer pain relief along with other benefits, such as cough or allergy relief. One particular danger cited by the FDA is that consumers may not be aware of how much acetaminophen they are actually taking, especially when combo products are used.
A report describing FDA concerns, issued on Wednesday, cites ‘extensive evidence’ that a lack of consumer awareness about the effects of acetaminophen on the liver heightens the risk of toxicity. When used in excess and in individuals particularly susceptible to liver toxicity (hepatotoxicity), liver damage can be severe.