FDA Issues Reminder on Combo APAP Drugs
The FDA has issued a reminder that healthcare professionals should cease prescribing or dispensing prescription combination products containing more than 325mg of acetaminophen per tablet, capsule, or other dosage unit due to the potential risk of liver toxicity.
Manufacturers of prescription combination products were initially requested to limit the amount of acetaminophen to no more than 325mg per dosage unit in 2011 and to add a warning label regarding the potential risk for severe liver injury. In January 2014, the FDA also recommended the discontinuation of prescribing and dispensing these combination drug products by healthcare professionals.
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. Currently, there is no available data showing that taking >325mg of acetaminophen provides additional benefits that outweigh the risk of 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.
If pharmacists receive a prescription for a product containing >325mg of acetaminophen per dosage unit, the FDA advises that they contact the prescriber to discuss a product with a lower dose. Because these products are no longer considered safe by the FDA, they have been voluntarily withdrawn and should be returned to the wholesaler or manufacturer.
For more information call (888) 463-6332 or visit FDA.gov.