Regulatory

FDA seeks less acetaminophen in prescription drugs

Last Updated: 2011-01-13 17:12:22 -0400 (Reuters Health)

By Susan Heavey

WASHINGTON (Reuters) - U.S. health regulators are requesting a limit on the amount of acetaminophen in prescription pain medicines in an effort to curb the risk of liver damage.

The move announced on Thursday aims to limit combination drugs such as the opioids Percocet (based on oxycodone) and Vicodin (based on hydrocodone) to 325 mg 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 mg of acetaminophen.

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

The FDA said it was asking affected companies to comply but stopped short of ordering the actions. Changes would be phased in over three years.

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

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

While about 80% of the acetaminophen market is nonprescription products, about 20% includes prescription combination products, according to the agency.