Painkillers at a crossroads as FDA decision looms
Pain is such a common problem in the United States that Vicodin is the most widely prescribed drug in the country. It alleviates the pain of surgery, soothes aching joints, and beckons to Gregory House, the misanthropic TV doctor played by Hugh Laurie.
Pain is such a common problem in the United States that Vicodin is the most widely prescribed drug in the country. It alleviates the pain of surgery, soothes aching joints, and beckons to Gregory House, the misanthropic TV doctor played by Hugh Laurie.
Vicodin and similar painkillers are so tightly woven into daily American life that if the Food and Drug Administration takes the advice an expert panel issued Tuesday and prohibits them, doctors and patients will scramble for alternatives, experts said.
"If they were to ban those, what do you think would happen tomorrow? It would be a mess," said Timothy Ives, associate professor at the University of North Carolina's Eshelman School of Pharmacy.
Ives said he had fielded several calls yesterday from patients who asked: "You're not cutting off my Percocets, are you?"
The FDA advisory panel recommended banning Vicodin and Percocet because they contain acetaminophen, which can cause liver damage if taken at higher-than-recommended doses. The panel also urged the FDA to lower maximum doses for acetaminophen, best known as the branded drug Tylenol.
The FDA still must decide whether to follow the panel's advice. The agency is not required to, but typically follows such recommendations.
Vicodin, made by Abbott Laboratories, of Illinois, and Percocet, made by Endo Pharmaceuticals Holdings Inc., of Chadds Ford, were recommended for a ban because some research has showed greater evidence of liver damage with these drugs.
That may be because many patients take painkillers over the long term, while also taking other medicines they do not realize contain acetaminophen, such as NyQuil and Theraflu.
Should the FDA ban Vicodin and Percocet, several experts said, doctors will have to explore other, more complicated ways to manage their patients' pain.
Percocet contains oxycodone and acetaminophen, and doctors could prescribe each of those independently, said Michael Ashburn, director of pain medicine and palliative care at the University of Pennsylvania Health System.
But many patients fail to take their medicine properly when they start taking more pills, a downside of that option, Ashburn said.
Vicodin contains hydrocodone and acetaminophen. Hydrocodone is not available as a separate drug in the United States, so doctors cannot prescribe the two ingredients as a substitute, Ashburn said.
Acetaminophen was included as an ingredient in the two drugs because it acts on different pain receptors than do hydrocodone and oxycodone.
"This is a cornerstone of pain-management therapy," Ashburn said.
Other painkillers, including aspirin and nonsteroidal anti-inflammatory drugs, or NSAIDs, come with their own risks, including kidney problems and gastrointestinal bleeding.
Despite the challenges a ban might pose, Ashburn, who has served on other FDA advisory panels, said he was confident the medical community could cope with any changes.
"The biggest concern for me would be how and when, not if," he said. Finding a source of a drug that contained only hydrocodone would be crucial to making such a transition, he added.
Several experts said solutions other than an outright ban could reduce the chance of acetaminophen overdose.
Eugene Viscusi, director of pain management at Thomas Jefferson University, said some drug labels are marked "APAP," an acronym for the chemical name for acetaminophen. Making sure all labels list acetaminophen could reduce the possibility that a patient might take too much of the drug, he said.
Doctors need to spend more time asking questions about which drugs patients are taking, Ashburn said. Many patients mention only prescription drugs when asked that question. When acetaminophen is involved, doctors also need to know how often a person takes Tylenol and NyQuil, as well as how much alcohol he or she consumes.
Ives said doctors also should consider running tests to gauge the health of a patient's liver and kidneys when they prescribe drugs containing acetaminophen.
"The real question ought to be, 'How well do you monitor these folks?' " Ives said.
The pharmaceutical industry likely will fight the proposed ban. Prescription drugs containing acetaminophen generated $1.4 billion in 2008 sales, according to data provider IMS Health Inc. Percocet accounted for about $130 million of that figure, roughly 10 percent of Endo's annual revenue.
Blaine Davis, the company's vice president of investor relations, said Endo already had taken steps to address concerns about possible overdose. About five years ago, the company introduced new Percocet formulations with less acetaminophen.
Endo plans to work with the FDA to find a way to keep the drug on the market, she said.