The US Food and Drug Administration (FDA) is asking healthcare professionals to stop prescribing combination prescription pain relievers that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit, citing the risk for liver damage.
The action targets prescription analgesics that contain both acetaminophen and another ingredient, typically opioids such as codeine, oxycodone, and hydrocodone. Some of these combination products now have as much as 750 mg of acetaminophen per dose.
In a statement, the FDA said, "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."
"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," they added.
The FDA said 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 1 acetaminophen-containing product at the same time; or combined alcohol with acetaminophen products.
Following Up on Request
As reported by Medscape Medical News, in January 2011, the 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.
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," the FDA said.
"In the near future FDA intends to initiate proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market," the agency said.
In the meantime, the FDA recommends that healthcare providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen.
The regulator also recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. "A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units)," the FDA said.
"When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product," they add.
OTC Products on Radar
The FDA said it will address over-the-counter (OTC) pain relievers and cold, sinus, and cough medicines that contain acetaminophen in a separate regulatory action. Normally, the maximum level allowed for these products is 500 mg, although a few extended-action pain relievers that are taken less frequently can go up to 650 mg.
"Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much," the FDA warns.
Healthcare providers and pharmacists who have questions about these products are encouraged to contact the Division of Drug Information at 888.INFO.FDA (888-463-6332) or email@example.com.
To report problems with these or other products, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online athttps://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.