asks doctors to limit acetaminophen in combination drugs
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[January 15, 2014]
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
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 January 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.
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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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