In advance of eliminating the availability of prescription combination drugs that contain more than 325 milligrams of acetaminophen per dosage unit, the U.S. Food and Drug Administration (FDA) on Tuesday recommended that physicians stop prescribing medications that exceed this limit, citing a risk of liver damage.
Acetaminophen is the leading cause of drug-induced acute liver failure in the United States, and no data exists demonstrating that taking more than 325 milligrams of acetaminophen per dosage provides additional benefits, the FDA said in its recommendation Tuesday.
Some prescription combination drugs that contain both acetaminophen and another ingredient, such as hydrocodone, have as much as 750 milligrams of acetaminophen per dose and are most commonly prescribed to manage pain from acute injuries and following surgery.
In 2011 the FDA began asking manufacturers to voluntarily limit the amount of acetaminophen in prescription combination drugs to no more than 325 milligrams per dosage by Jan. 14, 2014. “FDA requested this action to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen,” the statement said.
About half of manufacturers complied with the request. Prescription drug products that don’t meet the FDA requirement remain on the market temporarily, but the FDA plans to withdraw approval of these noncompliant prescription combination drugs “in the near future.”
In the meantime, the agency recommends physicians prescribe combination drugs that comply with the FDA limit. "A two-tablet or two-capsule dose may still be prescribed, if appropriate,” the FDA said. “In that case, the total dose of acetaminophen would be 650 milligrams (the amount in two 325 milligram dosage units)."
Physicians who prescribe larger doses of acetaminophen can expect calls from pharmacists. The agency recommended that pharmacists who receive a prescription for combination painkillers with more than 325 milligrams of acetaminophen contact the prescriber to discuss switching to a product containing lower doses of acetaminophen.
The FDA said it will address over-the-counter (OTC) acetaminophen products in a separate regulation. Warnings about the potential for liver damage already are required on labels of the hundreds of OTC products containing the drug.
“Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to take too much,” the agency said.
Questions can be directed to the Division of Drug Information at (888) INFO-FDA or via email.
