The U.S. Food and Drug Administration is advising health-care professionals to stop prescribing or dispensing pain relievers that contain more than 325 miligrams of acetaminophen per tablet due to concern over liver damage.
The Cayman Islands Public Health Department released an advisory Tuesday stating it would make this recommendation to all health-care workers locally.
Two years ago the FDA advised drug companies that manufacture combination medicines, which include acetaminophen, to limit acetaminophen to 325 mg per tablet, capsule, or other dosage unit by January 2014.
The FDA has not yet ruled on over-the-counter medications, but is advising the public to read labels to confirm if medications contain acetaminophen. Where this is the case, dosage should be kept within the recommended guidelines of 325 mg per tablet, capsule, or other dosage unit. The maximum dose for adults is 4,000 mg per day.
“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. “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.”
The FDA is advising doctors to prescribe combination drug products that contain 325 mg or less of acetaminophen, while pharmacists who receive a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit are being asked to contact the prescriber to discuss a product with a lower dose of acetaminophen.
“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,” the FDA said.
Cautions about liver damange
In January 2011, the FDA initially asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount to no more than 325 mg in each tablet or capture by Jan. 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.
“More than half of manufacturers have voluntarily complied with our request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available,” the FDA said.
The watchdog organization said it intends in the near future 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.
Cases of severe liver injury with acetaminophen have occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period; took more than one acetaminophen-containing product at the same time; or drank alcohol while taking acetaminophen products.
“Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death,” the FDA said.
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