On January 14, 2014, the Food and Drug Administration released a statement asking all healthcare professionals to discontinue prescribing and dispensing prescription combination formulations with more than 325 mg acetaminophen per tablet, capsule, or any other dosage unit. In January 2011 the FDA asked manufactures of acetaminophen containing prescription drugs to limit the amount of acetaminophen in their formulations to 325 mg or less by January 14, 2014. This latest recommendation came as the deadline for manufacturers to comply with the FDA request expired and some manufacturers have not reduced the amount of acetaminophen in their formulations.
The FDA hopes that reducing the amount of acetaminophen in prescription products will reduce the risk of liver injury due to acetaminophen overdose. Acetaminophen is one of the most used medications in the United States for pain and fever and has been associated liver failure, liver transplantation, and death. There are nearly 26,000 hospitalizations and 458 deaths related to acetaminophen associated overdose annually. Liver injury caused by acetaminophen most often occur when patients exceed the recommended dose of 4000 mg/day; combine alcohol with acetaminophen; or combine acetaminophen containing products. There is no good evidence that formulations with higher doses of acetaminophen per dose unit are more effective for pain.
According to the FDA more than half of manufacturers have changed their formulations. Abbott was the first manufacturer to limit the amount of acetaminophen in their combination product. They reduced the amount of acetaminophen in Vicodin to 300 mg in 2012. Norco, manufactured by Watson has 325 mg of acetaminophen. Lortab and many generic brands still contain 500 mg of acetaminophen.
The FDA is essentially asking healthcare providers to help reduce the risk associated with using acetaminophen by recommending that health care providers prescribe products with 325 mg of acetaminophen or less.
The FDA urges pharmacists to ask prescribers to switch to a product with less acetaminophen when they receive a prescription for a product with more than 325 mg of acetaminophen per dosage unit. A two tablet or two capsule dose (650 mg) may still be prescribed if appropriate. Interestingly, a few months ago pharmacists attempted to contact physicians about over prescribing of narcotics or suspicious narcotic prescribing and there was a backlash from the American Medical Association. Hopefully, pharmacists and physicians learned their lessons from that interaction and will work together to reduce prescribing and dispensing of large acetaminophen doses.
All healthcare providers that prescribe pain medicines should educate patients about the risks associated with acetaminophen and provide them with lists of products containing acetaminophen. Although widely used, and has few side effects when used appropriately, acetaminophen is a very dangerous drug when used inappropriately.
Comment on this article or post an article by joining the RxEconsult community.
Please Share on Your Social Networks