Acetaminophen Warning: FDA Says Limit Dose to 325 MG


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The Food and Drug Administration (FDA) issued an acetaminophen warning on Tuesday and recommends that healthcare professionals stop prescribing drugs that contain more than 325 milligrams of acetaminophen. Acetaminophen is a pain medicine that you may recognize from taking Tylenol. The FDA says that prescribing more than 325 mg of acetaminophen per dosage unit can put people at risk for liver injury.

Many people may not realize it, but a number of prescription and over-the-counter drugs contain acetaminophen. According to a statement released by the FDA at the beginning of the cold and flu season, "more than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever." For example, oxycodone (Percocet), hydrocodone (Vicodin) and codeine are combination drugs that contain acetaminophen. Sometimes these drugs may contain more than 325 mg of acetaminophen, which prompted the FDA to issue a warning.

"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 warning read.

Since people often don't realize that these combination drugs contain acetaminophen, they sometimes combine them with OTC drugs such as Tylenol or cold medications that contain acetaminophen. "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.

This acetaminophen warning is nothing new. In 2011, the FDA asked manufacturers to stop producing combination prescription drugs that contain more than 325 mg of acetaminophen. At the time of the current warning, the FDA notes that more than half of manufacturers have complied with the request. Since some manufacturers are still producing these pills three years later, the FDA now plans to begin working on withdrawing approval for medications containing more than the recommended level of acetaminophen because of the possible health risks.

The FDA plans to address the current recommended acetaminophen dosage for Tylenol and other OTC drugs in another regulatory action. The maximum daily amount of acetaminophen is 4000 mg, which may be taken in 1000 mg doses in products such as Extra Strength Tylenol. Since the FDA now advises against prescribing combo drugs that contain more than 325 mg of acetaminophen, it will be interesting to see if the FDA decides to reduce the current OTC dosage in the forthcoming regulatory action.

Check out the FDA's video acetaminophen warning below.

Image via YouTube