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FDA Recommends Limiting Acetaminophen in Prescription Medicines

acetaminophenThe United States Food and Drug Administration (FDA) has recently asked healthcare professionals to cease prescribing combination prescription pain relievers that contain more than 325mg of acetaminophen per tablet, citing the increased risk for liver damage.[1]

This action specifically targets prescription analgesics that contain both acetaminophen and an opioid, such as codeine, oxycodone, and hydrocodone.1 Some of these combination products are available with as much as 750mg of acetaminophen per dose.1

The FDA released a statement that said “There are no available data to show that taking more than 325mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. 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.”1

According to the FDA, cases of severe liver damage due to acetaminophen overuse has occurred in patients who regularly take more than the prescribed dose of acetaminophen in a 24-hour period, those who take more than one acetaminophen-containing product at the same time, and those who drink alcohol with acetaminophen products.1

In January of 2011, the FDA has asked manufacturers of prescription combination drugs to limit the amount of acetaminophen to no more than 325mg per dosage unit by January 14, 2014.1 While more than half of manufacturers have voluntarily complied with the FDA request, some products containing more than 325mg of acetaminophen per dosage unit will remain available.1

The FDA said, “In the near future, the FDA intends to initiate proceedings to withdraw approval of prescription combination drug products containing more than 325mg of acetaminophen per dosage unit that remain on the market.”1

Not only has the FDA recommended that healthcare providers consider prescribing combination drug products that contain 325mg or less per dose, but they have also recommended that pharmacy staff contact the prescriber to discuss a product with a lower dose of acetaminophen if they receive a prescription with a higher dose.1

“A two tablet or two capsule dose may still be prescribed, if appropriate,” the FDA said. “In that case, the total dose of acetaminophen would be 650mg, or the amount in two 325mg dosage units. However, when making individual dose determinations, healthcare providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.”1

As for over-the-counter (OTC) pain relievers and cold, sinus, and cough medicines that contain acetaminophen, the FDA will address those dosages in a separate regulatory action.1 While normally, the maximum level allowed for these products is 500mg, a few extended-action pain relievers that are taken less frequently give up to 650mg.1

The FDA said, “Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.”1

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