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U.S. FDA asks doctors to limit acetaminophen in combination drugs

Source: Reuters - Wed, 15 Jan 2014 12:55 AM
Author: Reuters
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Jan 14 (Reuters) - U.S. health regulators recommended on Tuesday that healthcare professionals stop prescribing combination drugs that contain more than 325 milligrams of acetaminophen per tablet, capsule, or other dosage unit, citing the risk of liver damage.

Limiting the quantity per dosage unit will reduce the risk of inadvertent overdose, which can lead to liver failure, liver transplant and death, the Food and Drug Administration said. It cited the fact that no available data showed that taking more than the recommended dose provided benefits that outweighed the added risks. (http://link.reuters.com/nen95v)

Inadvertent overdose from combination drugs containing acetaminophen, also known as paracetamol in most countries outside the United States, accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, the agency said.

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

In January 2011, the FDA asked manufacturers of combination drugs containing acetaminophen, sold globally under trade names such as Tylenol and Panadol, to limit acetaminophen doses to no more than 325 mg in each tablet or capsule by Jan. 14, 2014. (http://link.reuters.com/hyn95v)

Some of these products still remain available, the agency said.

The FDA also suggested that pharmacists who receive a prescription for a combination product with more than the recommended dose contact the prescriber to discuss using a lower dose.

In the near future, the FDA plans to institute proceedings to withdraw approval for combination drugs that remain on the market, it said in a statement.

Acetaminophen, one of the most commonly used drugs in the United States, is widely used in both prescription and over-the-counter products to reduce pain and fever. (Reporting by Natalie Grover in Bangalore. Editing by Andre Grenon)

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