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FDA Urges Doctors To Respect Acetaminophen Dosage Limits

The Food and Drug Administration cautioned doctors about the increased risks of liver damage, while warning manufacturers over non-compliance.

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By John Lavitt

01/16/14

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The U.S. Food and Drug Administration (FDA) is urging doctors to stop prescribing painkillers that contain more than 325 milligrams of acetaminophen after reports of severe liver damage. The active ingredient in the over-the counter pain reliever Tylenol, acetaminophen is a secondary ingredient in many prescription opioid painkillers, including Vicodin and Percocet.

On account of its toxicity, acetaminophen dosages over 325 mg can lead to liver failure. Highlighting the danger, the FDA is trying to halt the prescribing of these combination products that often have as much as 750 mg per dose. "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 safety statement. "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.”

Although half of the painkiller manufacturers have voluntarily complied with the FDA, the other half have yet to heed their request. Since many of the opioid combination products still contain more than 325 mg of acetaminophen per dosage, the FDA is ready to take action. "In the near future FDA intends to initiate 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 FDA said.

To protect patients, the FDA also recommends that pharmacists alert physicians when they encounter a prescription with an acetaminophen dosage above the 325 mg limit. The implication being if doctors are unable protect their patients, then pharmacists should be the second line of defense.

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