If 2 Painkillers Are Banned, What Next?

THURSDAY July 2, 2009 -- Banning the popular painkillers Percocet and Vicodin, which a U.S. health advisory panel has urged, would not be as drastic as it sounds, some medical experts contend.

The reason, they say, is that other options are available.

A U.S. Food and Drug Administration advisory panel made its recommendation Tuesday. It followed the release in May of an FDA report that found that many consumers aren't aware that severe liver damage, and even death, can result from overuse of acetaminophen, which is easier on the stomach than such painkillers as aspirin and ibuprofen.

Vicodin and Percocet combine acetaminophen with an opiate narcotic in one pill. Vicodin contains the narcotic hydrocodone, and Percocet contains oxycodone. Both drugs are prescribed to treat moderate to severe pain.

But acetaminophen is the active ingredient in such popular over-the-counter pain relievers as Tylenol and Excedrin. And consumers may also not know that acetaminophen is present in many other over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose.

And that's what's prompting the FDA's concern.

"It really makes sense to do what the panel is suggesting," said Dr. Scott Fishman, chief of the pain medicine division and a professor of anesthesiology at the University of California, Davis, and president of the American Pain Foundation. "The key is that the public needs to understand that they [the FDA] are not voting to ban the drugs [contained in the pill: the opiate and acetaminophen]. The drugs are fine. It's the combination of the drugs in one pill. Each drug has its own problems but, used separately, can be used safely."

Narcotic painkillers such as hydrocodone and oxycodone run the risk of being abused. "We want to get tighter control," Fishman said.

Using two pills instead of one, if needed, would enable physicians to better fine-tune the amount of each drug that their patients would be getting, reducing the risk of an overdose of acetaminophen. An estimated 42,000 Americans are treated in hospitals each year for acetaminophen overdoses, half of which are accidental.

"I agree in theory with what they [the FDA advisers] are doing because ... even though experts say 4,000 milligrams [of acetaminophen] is a toxic dose, some people believe as little as 2,000 can cause liver problems," said Dr. Joseph Shurman, chairman of pain management at Scripps Memorial Hospital in La Jolla, Calif.

And some people can achieve pain relief from just one of the components in Percocet, he explained.

Oxycodone alone is "probably just as effective for pain," Shurman said. "Tylenol [acetaminophen] theoretically is for pain and fever, but some people question if it has an anti-inflammatory effect. We're not sure of the exact mechanism."

Currently there is no pill that contains hydrocodone alone, but Shurman said that a slow-release version is close to arriving on the market.

Patients and doctors do need to guard against using too much of either the narcotic or the acetaminophen if only one is being taken at a time, Shurman said.

But an even bigger concern, he said, is use of over-the-counter acetaminophen products, of which Tylenol and Excedrin are among the most popular.

"People can walk into [a store] and buy a bottle of Tylenol and take 10 pills of 500 milligrams each so it's over the toxic level," Shurman said. "We know that a significant number of patients don't follow doctor's directions, especially if they're in pain."

The FDA panel called for lowering the recommended maximum daily dose of nonprescription acetaminophen, which is currently 4 grams -- equal to eight 500-milligram pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.

The panel also voted to limit the maximum single dose of acetaminophen to 650 milligrams (two pills of 325 milligrams each). The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams (two 500-milligram pills). The 1,000-milligram dose should be available only by prescription, the panel said.

The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so, and Fishman predicted it would in this case as well.

"While it's very convenient to have them in one pill, safety trumps convenience," Fishman said.

Dr. Sandra L. Kweder, deputy director of the FDA's Office of New Drugs at the Center for Drug Evaluation and Research, gave a strong hint Tuesday of what the agency might do with the advisory panel's recommendations.

"I think the top recommendation of this committee was that the agency needs to do something to address and decrease the usual dose of acetaminophen, both for over-the-counter products and also prescription combination products," Kweder said during a press conference.

She added, "There was a clear message that there is a high likelihood of overdose from prescription narcotic/acetaminophen combination products. If we don't eliminate these combination products, we should certainly at least lower the usual acetaminophen dose patients receive in those prescription combination products."

At the very least the FDA should require new warning labels on these prescription combinations that alert patients to the potential of liver damage if they take too much acetaminophen, she said.

More information

The U.S. National Library of Medicine has more on acetaminophen.

Posted: July 2009


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