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FDA: Acetaminophen Doses Over 325mg Linked to Liver Damage

Filed January 15th, 2014 Eric

The U.S. Food and Drug Administration (FDA) is recommending that healthcare professionals stop prescribing combination drugs that contain high doses of acetaminophen due to an increased risk of liver failure.

The FDA said combinations should not occur with doses that have 325 milligrams of acetaminophen per tablet or capsule, Reuters reported. By reducing the quantity per dosage unit, the risk of inadvertent overdose will decrease, according to the agency. An overdose of acetaminophen can lead to liver failure, liver transplant and death, the FDA said. The agency also said that there is no available data that shows taking more than the recommended dose provided benefits that outweighed the added risks, Reuters reported.

Accidental overdose of combination drugs containing acetaminophen is a major problem in the U.S. According to the FDA, this type of overdosing makes up close to half of all cases of acetaminophen-related liver failure in the country. The agency reported that an estimated 800 cases of liver failure are linked to acetaminophen overdose each year. In many cases, the overdoses prove fatal.

Acetaminophen – commonly sold as Tylenol – is one of the most commonly used drugs in the U.S. It is taken to reduce pain and fever and is available by both prescription and over-the-counter. The National Institutes of Health recommends that people should not go over 4,000 milligrams of acetaminophen a day, CBS News reported.

Combination acetaminophen products are often prescribed to patients to treat pain resulting from acute injuries, post-operative pain, or pain following dental procedures, Reuters reported.

This is not the first time the FDA has addressed the dangers of high doses of combination drugs containing acetaminophen. In January 2011, the FDA asked manufacturers of these drugs to limit acetaminophen doses to no more than 325 mg in each tablet or capsule by Jan. 14, 2014, Reuters reported. The FDA also suggested that pharmacists who receive a prescription for a combination product with a higher than recommended dose get in touch with the prescriber to converse about switching to a lower dose. The agency also mandated that all prescription combination acetaminophen products include black box warnings on their labels, highlighting the risk of liver damage.

In 2011 the agency said in a statement, β€œmost of the cases of severe liver injury 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.”

According to Reuters, at some point in the near future the FDA plans to institute actions to withdraw approval for any combination drugs that remain on the market, it said in a statement.

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