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FDA Warns Against Acetaminophen Doses over 325 mg

Update Date: Jan 15, 2014 09:22 AM EST
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Acetaminophen is a prescription drug that has been used for years in reducing fevers and relieving pains and aches. Despite how long acetaminophen has been on the market the United States' Food and Drug Administration (FDA) just recommended physicians to consider limiting combination drugs prescriptions of acetaminophen to no more than 325 milligrams. According to the FDA, too much acetaminophen increases the risk of liver damage.

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The National Institutes of Health states, "Acetaminophen overdose is one of the most common poisonings worldwide."

The FDA is warning physicians against prescribing combination drugs, which would be two or more drug prescriptions of acetaminophen. Acetaminophen can be found in drugs with brand names, Percocet, Vicodin and Tylenol with Codeine. The FDA states that over-the-counter Tylenol does not fall under this new warning. However, the agency plans on addressing acetaminophen in over-the-counter drugs in a different 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 FDA wrote according to CNN. "Many consumers are often unaware that many products [both prescription and OTC] contain acetaminophen, making it easy to accidentally take too much."

The agency reported that taking too much acetaminophen can lead to liver failure and even death. Reported cases reveal that people who suffered from liver damage took more than their prescription dose, took more than one drug containing acetaminophen or drank alcohol while taking prescription drugs with acetaminophen. Currently, the maximum limit for adults is 4,000 mg of acetaminophen per day.

In January 2011, the FDA asked drug-manufacturing companies to limit the amount of acetaminophen to 325 mg per capsule or tablet. Even though the majority of companies decided to comply, there are still combination drugs, such as Tylenol with Panadol, that get prescribed. In order to prevent the cases of liver damage related to acetaminophen from increasing, the FDA has stated that it aims to prohibit prescription combination drugs that contain high levels of acetaminophen.

The press release can be found here.

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