Product News and Recalls

FDA: discontinue high-dose acetaminophen

The FDA is asking health professionals to discontinue prescribing acetaminophen products that contain over 325 mg per dose. A recent FDA statement reports that there is no data proving that doses over this amount provide any benefit to negate the increased risk. Acetaminophen is often found in prescription drugs taken as pain relievers and is often found in conjunction with other active ingredients.

Acetaminophen can be harmful to the liver in large doses. It has been known to cause liver failure, liver transplant, and even death. Inadvertent overdose can occur, especially when patients do not realize that they are taking more than one acetaminophen-containing product. Overdose can also be caused when alcohol is combined with acetaminophen, or when more than a prescribed dose is taken in a 24-hour period.

The recent FDA action to limit the concentration of acetaminophen is directed towards prescription products. Regulation of over-the-counter acetaminophen products is expected in the future because consumers sometimes do not realize they are taking both prescription and over-the-counter acetaminophen.

A list of the affected products can be found on the FDA website. Pharmacists are also recommended to contact prescribers who are recommending more than 325 mg and discuss a different option with lower dose.

Although more than half of the manufacturers have complied with this recommendation, some products still remain available that do not meet these requirements. In the future, the FDA is looking to withdraw its approval of products that contain more than 325 mg of acetaminophen due to the unwarranted risk that they present.

You should contact a medical professional if you are experiencing health concerns. If you believe you of a loved one has suffered liver injury from acetaminophen contact Lopez McHugh for a free initial consultation by calling us, toll free, at (877) 737-8525.