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Acetaminophen Alert from FDA

Timely Insights on Laws, Issues and New Developements

TylenolA Jan. 15, 2014 Acetaminophen Alert from FDA announced that half of Acetaminophen product makers have failed to meet the new 325 mg requirements. Half the makers of prescription painkillers have missed a January 14 deadline to restrict doses of acetaminophen to 325 milligrams per pill or capsule. The FDA had ordered, in Jan. 2011, that any company making medicine containing acetaminophen restrict doses to just 325 mg. by Jan. 14, 2014.

Acetaminophen Approval withdrawn

For its next move, the FDA will withdraw approval for prescription painkillers exceeding 325 milligrams of acetaminophen.

The agency took this action under the assumption that limiting the size of acetaminophen doses will reduce the risk of accidental overdoses. Excess acetaminophen can cause severe liver damage, liver failure, even death. There is also no evidence to demonstrate that acetaminophen dosages in excess of 325 milligrams provide any additional benefits that could outweigh the risks of potential liver damage.

More than half of all acetaminophen-related liver injuries are caused by accidental overdoses involving prescription painkillers.

Among several hundreds of painkillers containing acetaminophen, Vicodin ranks No. 1 for prescribed painkillers since 1997, though it also contains an opioid.  Most products containing acetaminophen are used to treat the most common human ailments: moderate aches and pains, coughs, colds, fevers, flu. Acetaminophen problems occur usually because many people do not know that acetaminophen is an ingredient in these commonly used  products.

Acetaminophen Alert for Liver Failure

Acetaminophen can raise the risk of life-threatening liver failure if one takes more than the prescribed amount in a 24-hr. period. This can often occur when one takes multiple acetaminophen products simultaneously. Consuming alcohol while also taking acetaminophen can also overtax the liver and cause it to fail from the toxic burden overloading the liver.

Acetaminophen Lawsuits

Matthews & Associates Law Firm is handling acetaminophen injury cases in all 50 states and Puerto Rico. If you or someone you love has been injured by acetaminophen, email a Tylenol Lawyer for a potential Tylenol lawsuit against the maker, or call us toll free at (888) 923-7001.


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by Matthews & Associates

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