January 13, 2011

FDA Wants To Limit Acetaminophen In Medicines

The FDA is ateempting to limit the amount of acetaminophen in prescription pain medicines in an effort to curb the risk of liver damage.

The move, announced on Thursday, is an ambitious attempt to limit combination drugs like the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and calls for them to carry a "black box" warning about potential liver failure.

Some of these medicines now contain as much as 750 milligrams of acetaminophen, which is a drug that is sold over the counter as a generic painkiller by Johnson & Johnson.

"This change will provide an increased margin of safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem," the FDA wrote in a public notice.

The move affects products made by Johnson & Johnson, Endo Pharmaceuticals Holding Inc., Watson Pharmaceuticals Incorporated and Boehringer Ingelheim's Roxane Laboratories unit.

The FDA said it was asking affected companies to comply.

Acetaminophen has long been known to cause liver damage if patients overdose or take multiple products that contain the ingredient.

The FDA started to re-examine the issue in 2002, but its outside advisers at that time cited a lack of data to target dosing.  Another advisory panel in 2009 recommended some of the changes requested on Thursday.

According to the FDA, acetaminophen is one of the most commonly used U.S. drugs and is often combined with other medications.  It also said that prescription versions often include it along with opioid painkillers.

According to FDA, while about 80 percent of the acetaminophen market is nonprescription products, about 20 percent includes prescription combination products.


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