FDA: Prescribers, dispensers should stop use of combination painkillers with more than 325 mg of acetaminophen

FDA is recommending healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit. 

There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury, according to FDA. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death. 

 Cases of severe liver injury with acetaminophen have occurred in patients who:

• Took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period; 
• Took more than one acetaminophen-containing product at the same time; or 
• Drank alcohol while taking acetaminophen products.

“This is a major issue as most manufacturers of acetaminophen make the 500-mg strength. Now all manufacturer’s will have to cut back,” said James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City. 

“It is interesting that such a commonly used drug can cause such a severe problem,” Dr. Wooten added.  “We have known for years why acetaminophen causes hepatotoxicity but FDA is now re-assessing the risk to the public. I do believe with a lower dosage unit the risk will be reduced.  I agree with FDA in this case.”

In January 2011 FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. FDA requested this action to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, postoperative pain, or pain following dental procedures.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. FDA will address OTC acetaminophen products in another regulatory action. Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.

More than half of manufacturers have voluntarily complied with the FDA request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. FDA intends to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.

“Providers have been preparing for the reduction in acetaminophen content since the announcement in 2011,” said Michelle Hilaire, PharmD, clinical pharmacist at the Fort Collins Family Medicine Center, a service of University of Colorado Health, in Fort Collins, Colo. “Patients often don’t look at acetaminophen content in everyday medication-cough and cold products, sleep agents-but considered them safe since they didn’t require a prescription.  Since the announcement in 2011, providers have become better about asking patients about acetaminophen content in everyday products.”

Limiting the amount of acetaminophen in narcotic combinations has not reduced the effectiveness of combination products, but will allow for increased patient safety, according to Dr. Hilaire. 

“These restrictions have opened dialogue between providers and patients when choosing pain medication options,” she said.

For more information visit: www.fda.gov/acetaminophen