FDA considers new recommendations on acetaminophen use

Washington鈥擳he U.S. Food and Drug Administration is weighing advisers’ recommendations for new guidance on products containing acetaminophen because of concerns about potential liver damage.

Acetaminophen is an aspirin substitute used in products prescribed by dentists and physicians and available over the counter to reduce pain and fever.

The FDA convened a public advisory committee meeting June 29-30 regarding acetaminophen use in over-the-counter and prescription products, the potential for liver injury and potential interventions to reduce the incidence of liver injury. The committee recommended new standards for acetaminophen-containing products, according to media reports.

For many years, the dental and medical professions have relied on acetaminophen as a valuable primary or alternative analgesic, including its availability in prescription-product combinations of the drug with opioids such as Percocet and Vicodin. Recent systematic reviews have supported the prescription of doses of 500 to 1,000 mg of acetaminophen, alone or in combination with a single opioid, oxycodone 5 mg for example, for short-term management of dental pain.

As long as appropriate dosages and dose intervals are observed, prescribing acetaminophen can still be considered relatively safe for patients without a history of liver disease or in individuals otherwise not at-risk for hepatic complications given the short-term manner in which it is generally utilized in relieving dental pain, according to the ADA Council on Scientific Affairs.

Additional information on acetaminophen is available at www.ada.org.

The FDA-convened advisory panel recommended changes in packaging and dosage for products containing acetaminophen. FDA generally follows an advisory committee’s recommendations but is not required to.