FDA Puts More Restrictions on APAP Prescribing

The FDA no longer wants healthcare professionals to prescribe or dispense prescription combination drug products containing more than 325mg of acetaminophen per tablet, capsule or other dosage unit. 

The recommendation is substantiated by the lack of available data to show that doses greater than 325mg of acetaminophen per dosage unit provide any additional benefit to the patient.

Acetaminophen is a widely used pain and fever medication available both by prescription and over-the-counter. As a prescription, acetaminophen is typically added in combination with other pain relievers, namely opioids.

At high-doses, acetaminophen has the potential to cause serious liver injury. The FDA hopes that by limiting the amount of acetaminophen in these prescription combination products, the risk of severe liver injury will also be reduced.

Limiting the amount of acetaminophen in combination products has been on the FDA’s agenda since its initial communication with manufacturers back in January 2011

At that time, manufacturers were asked to stop producing products containing greater than 325mg of acetaminophen per dosage unit.  

As of yesterday, all manufacturers were expected to make the necessary changes, however some products with higher doses still remain on the market.

For all healthcare professionals, the FDA recommends the following:

  • Prescribers should only write prescriptions for combination products that contain 325mg or less of acetaminophen
  • Pharmacists who receive prescriptions for products containing more than 325mg of acetaminophen per dosage unit should contact the prescriber to discuss products that contain a lower dose
  • A two tablet or two capsule dose may still be prescribed (total dose of 650mg), if appropriate
  • Always consider the amounts of both acetaminophen and opioid components when prescribing combination products

For more information call (888) 463-6332 or visit FDA.gov