The Food and Drug Administration is warning against prescription combination drugs with more than 325 mg of acetaminophen, citing the risk of liver damage.
“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,” the FDA said in a statement Tuesday.
It is recommending health professionals stop prescribing or dispensing combination drugs that contain more than 325 mg of acetaminophen per dose. A combination drug contains two or more drugs.
Acetaminophen is often used in combination with opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine).
The warning does not apply to over-the-counter drugs such as Tylenol, which contains acetaminophen. But the FDA said it will address over-the-counter acetaminophen products in another regulatory action.
“Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much,” the FDA said.
Those who have suffered severe liver damage from acetaminophen include people who took more than the prescribed dose, those who took more than one acetaminophen product at the same time, and those who drank alcohol while taking acetaminophen products, the FDA said.
An acetaminophen overdose can lead to liver failure or death.
In 2011, the FDA started asking manufacturers to limit the amount of acetaminophen in prescription combination drugs to 325 mg per capsule or tablet by January 2014. While more than half of the manufacturers agreed, some combination drugs with higher amounts of acetaminophen remain on the market.
The agency says it plans to start the process of withdrawing approval of prescription combination drugs with high amounts of acetaminophen per dose.