FDA recommends health professionals prescribe no more than 325 mg of acetaminophen per dose

Agency promises action to come concerning acetaminophen OTC formulations

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit. 

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 agency noted. 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. 

"We recommend that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. We also recommend 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," the agency stated. "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). 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." 

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. "We requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain or pain following dental procedures," the FDA noted.

More than half of manufacturers have voluntarily complied with the request, FDA reported. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. "In the near future we intend to institute 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 stated. 

Acetaminophen is also widely used as an over-the-counter pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. The FDA plans to address OTC acetaminophen products in another regulatory action.

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