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Pain Management Health Center

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FDA May Restrict Acetaminophen

Advisers Tell the Agency to Lower Over-the-Counter Dose of Popular Pain Drug

Call to Eliminate Some Acetaminophen Products continued...

The combination of hydrocodone and acetaminophen, for instance, has been the most frequently dispensed drug since 1997, according to the FDA.

Richard DeNisco, MD, MPH, medical officer at the National Institute of Drug Abuse and a panel member, said that so much acetaminophen is going out to people in hydrocodone/acetaminophen mixes that he is uncertain why there is not more liver damage.

Prohibiting these combined products “would rock the system,” he said, but the two products should be prescribed separately, if necessary.

The combination prescription products, which have rapidly increased in use in the last five years, are clearly the biggest cause of the acetaminophen overdose, said Marie Griffin, MD, professor of preventive medicine at Vanderbilt University. But she worried that people will simply turn to plain narcotics, if the combinations are eliminated. “We need a broader answer to chronic pain, because these drugs are being used extensively in the older population," Griffin said during the meeting. "And I am not sure that practitioners feel like they have many other choices.”

On the other hand, the committee declined to vote for eliminating combination acetaminophen products that are sold over the counter.

Karl Lorenz, MD, who is with the VA Los Angeles Healthcare System, said that many people are being creative in managing low level chronic pain. “I just think we have to be cautious about eliminating an entire category of products that many people find useful,” he said.

Black Box Warning Advised for Acetaminophen Combination Products

The advisory committee also voted overwhelmingly to recommend that the FDA require a boxed warning -- often called a black box warning -- on the labels of prescription acetaminophen combination products, with members noting this is considered the highest precaution the agency can give.

They also called for limiting formulations of liquid over-the-counter acetaminophen to only one concentration level in order to reduce confusion when people give the medicine to children.

Linda Suydam, president of the Consumer Healthcare Products Association, which represents companies that make over-the-counter products, objected to the committee’s recommendations for new limits on acetaminophen in over-the-counter products.

“CHPA strongly believes that patients and physicians need to have a wide range of dosing available for patients who need their acetaminophen-containing products,” she said, asserting there is little data to support the idea that patients are harmed at current levels.

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