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FDA tightens acetaminophen recommendations

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Reaffirming the link between taking too much acetaminophen and developing liver disease, the U.S. Food and Drug Administration on Jan. 14 escalated its recommendations on the use of the pain reliever.

“FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit,” the agency wrote in its safety alert. “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. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.”

The recommendations for health care professionals comes two years after the FDA told manufacturers of the drug to “limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. FDA requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen.”

Acetaminophen can be found in pain and fever medications. One of them is Tylenol, the maker of which has been a defendant in pharmaceutical injury Tylenol lawsuits.

The U.S. Judicial Panel on Multidistrict Litigation has consolidated 120 pending Tylenol lawsuits filed either by or on behalf of acetaminophen victims. The panel centralized those cases in the federal Eastern District of Pennsylvania in April 2013.

In its order establishing the MDL, the panel wrote, “[The] personal injury and wrongful death actions before us involve allegations that ingesting acetaminophen – specifically, over-the-counter Tylenol in its various forms – can cause serious liver damage, including liver failure, even when taken as directed. … The actions share factual issues concerning the design, manufacture, labeling, marketing, and sale of Tylenol.”

Until recently, plaintiffs in Tylenol lawsuits may assert, one could have taken Tylenol as directed and still could have suffered liver damage, the risk of which the manufacturer, Johnson & Johnson, allegedly either knew or should have known.

Many victims and victims’ families have decided not to let J&J off the hook.

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