Join ADAMember Log In




FDA issues acetaminophen safety recommendation

The U.S. Food and Drug Administration recommends that dentists and other health care providers stop prescribing and dispensing combination drugs that contain more than 325 milligrams of acetaminophen.
 
In safety information on its website, www.FDA.gov, the FDA said that there is no available data showing it is beneficial, in relation to risks, for anyone to take more than 325 milligrams of acetaminophen per dosage unit. Risks for taking more than 325 milligrams of acetaminophen per dosage unit include liver injury, the FDA said. The FDA also said that limiting the amount of acetaminophen per dosage unit reduces the risk of severe liver injury from inadvertent overdose, which can lead to liver failure, liver transplant and death.
 
Three years ago, the FDA asked drug manufacturers to limit the amount of acetaminophen in combination drugs to 325 milligrams per tablet or other dosage unit by Jan. 14, 2014. The FDA said that more than half of manufacturers voluntarily complied with the request. This means that prescription combination drugs containing more than 325 milligrams per dosage unit remain available. The FDA intends to withdraw approval of prescription combination drugs containing more than 325 milligrams of acetaminophen per dosage unit.
 
The FDA also recommends that pharmacists, after receiving a prescription for a drug combination product containing more than 325 milligrams of acetaminophen per dosage unit, contact prescribers to discuss alternative products with a lower dose of acetaminophen.
 
Dentists and other health care providers with questions can contact the Division of Drug Information at 1-888-463-6332 or druginfo@fda.hhs.gov. Providers and patients may also report adverse drug events or side effects related to the use of acetaminophen combination drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Call 1-800-332-1088 to request a reporting form.