What's Behind the FDA's New Limits on Acetaminophen?
In a safety alert earlier this week, the FDA recommended that health care providers discontinue prescribing and dispensing combination drug products that contain more than 325 mg of acetaminophen in each tablet, capsule, or dosage unit.
The FDA also recommends that pharmacists who receive a prescription to be filled for a combination product with more than 325 mg of acetaminophen per dosage unit contact the prescriber to discuss a lower dose. A 2-tablet or 2-capsule dose still may be prescribed if appropriate, however.
According to the FDA's statement, taking more than 325 mg of acetaminophen per dosage unit provides no additional benefits that outweigh the risk of liver injury. What's more, limiting dosage units stands to reduce number of acute acetaminophen overdose events and decrease the number of cases of acetaminophen-induced hepatotoxicity.
While acetaminophen is found in prescription and over-the-counter products, the FDA's recommendation covers only prescription acetaminophen-containing products. "FDA will address OTC acetaminophen products in another regulatory action," the statement said.
In January 2011, the FDA specified that manufacturers of prescription acetaminophen combination products must limit the maximum quantity of acetaminophen to 325 mg per dosage unit. Manufacturers had been required to make this dosage change by Jan. 14, 2014. In addition, the FDA required the inclusion of a package warning to alert consumers about the potential risk for severe hepatic injury. More than half of manufacturers voluntarily complied with the FDA’s request. However, some prescription combination drug products containing more than 325 mg of acetaminophen remain on the market, and the FDA intends to begin proceedings to withdraw approval of these drugs.
—Michael Gerchufsky
Reference:
US Food and Drug Administration. Acetaminophen prescription combination drug products with more than 325 mg: FDA statement - recommendation to discontinue prescribing and dispensing. http://www.fda.gov. Published January 14, 2014. Accessed January 16, 2014.
More on acetaminophen from Consultant for Pediatricians:
• Acetaminophen Toxicity in Children: Diagnosis, Clinical Assessment, and Treatment of Acute Overingestion, by Germaine L. Defendi, MD, MS, FAAP