Panel advises FDA to decrease doses of acetaminophen in over-the-counter medications, ban two painkillers

An FDA advisory panel recently made several recommendations regarding the use of acetaminophen, including banning two prominent pain-relieving drugs and limiting the maximum dosage of acetaminophen in over-the-counter (OTC) medications.

In a two-day joint meeting, members of the FDA advisory committees for drug safety and risk management, anesthetic and life support drugs and nonprescription drugs convened to examine liver injury associated with the use of acetaminophen in OTC and prescription drugs and to formulate methods to prevent acetaminophen overdose.

According to the New York Times, the panel recommended banning Percocet (Endo Pharmaceuticals) and Vicodin (Abbott Laboratories) in a 20-17 vote.

In a 24-13 vote, they also suggested lowering the maximum allowed dosage of acetaminophen in OTC medications from 500 mg to 325 mg.

The group also called for decreasing the maximum daily dosage to less than 4,000 mg. However, the panel voted against recommendations to limit the number of pills contained in each bottle and banning combination medications that include acetaminophen.

Orthopedics Today Rehabilitation Section Editor Mary Ann E. Keenan, MD, applauded the panel for taking a closer look at anecdotal reports regarding liver dysfunction in patients taking acetaminophen.

“I think one of the challenges will be for us to find appropriate analgesics when we just need mild analgesics in some of our patients who are taking anticoagulants such as Plavix and Coumadin, because then you have a concern about bleeding if you begin adding the nonsteroidal anti-inflammatory medications as you bring in ibuprofen and things like that,” Keenan told Orthopedics Today.

She added, “The other thing is making sure that people are aware of not just saying, ‘Do not take acetaminophen,’ but looking at some of the commonly used analgesics that contain acetaminophen, like Tylenol with [codeine].”

Keenan also said that physicians should be aware of patients who are at-high risk for liver disease or have a history of the condition.

David Cooper, MD, noted that guidelines issued by the American Academy of Orthopaedic Surgeons recommend using acetaminophen as an initial treatment for osteoarthritis.

“I think that [the panel recommendations] will impact orthopedic surgeons in terms of not giving it as a first-line treatment for osteoarthritis,” Cooper said.

Since the news of the FDA advisory panel’s recommendations has been released, Cooper has received questions from patients regarding acetaminophen use.

“Patients who are taking Tylenol for their osteoarthritis [are] now calling me and wanting to know whether they should consider taking as much, and I tell them no,” he said.

Reference:
Harris G. Panel recommends ban on two popular painkillers. NYTimes.com. July 1, 2009.