The government announced Thursday that it would sharply restrict some of the nation’s most popular prescription painkillers, saying they cause many patients to poison themselves with overdoses of the drug acetaminophen.
The decision by the Food and Drug Administration fell short of the ban on pills like Percocet and Vicodin recommended by an advisory panel in 2009. Instead, manufacturers of these drugs, which combine narcotics with acetaminophen, have three years to reformulate them or stop making them altogether.
Under the new limit, the pills may contain no more than 325 milligrams of acetaminophen – less than half the amount found in many of them now.
The action does not apply to over-the-counter pills like Extra Strength Tylenol, which also have more than 325 milligrams of acetaminophen and which the advisory panel also recommended banning. But more actions could be ahead, officials said.
The F.D.A. will require more explicit warning labels on the prescription medicines about the risk of overdosing with acetaminophen.
“F.D.A. is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Dr. Sandra Kweder, deputy director of the agency’s new drug office.
Acetaminophen, which relieves pain and fever and is also known as paracetamol and APAP, is one of the world’s most popular medicines. In 2005, Americans bought 28 billion doses of remedies that contained it. And drugs that combine acetaminophen with opioids like codeine, oxycodone and hydrocodone are prescribed more than 200 million times each year.
The problem, the drug agency said, is that many patients, unaware of the pills’ acetaminophen content, also take over-the-counter painkillers like Tylenol, exposing themselves to side effects that can be life-threatening.
Even recommended doses of acetaminophen can cause liver damage in some people. More than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.
Often the overdose results when a patient takes one acetaminophen-based medicine for back pain, another for migraines, and perhaps a third for cough and cold symptoms.
Federal drug regulators have tried for decades to cut down on acetaminophen’s toll, but little changed until June 2009, when the F.D.A.’s panel of experts voted by a bare majority to call for a ban on drugs that combine acetaminophen with narcotics.
Dr. Kweder said Thursday that a ban would have meant “disruption for patients in pain” and that the 325-milligram limit would not weaken the medicines’ painkilling power.
“We don’t believe we’re making these products less effective,” she said. “The amount of acetaminophen in these products has gradually crept up over the years.”
Dr. John Markman, director of the Neuromedicine Pain Management Center at the University of Rochester Medical Center, applauded the decision and said an outright ban would have led patients to take other, equally risky drug combinations. Now the F.D.A. will be able to study whether this more moderate step prevents drug-induced liver injuries.
But Dr. William M. Lee, a professor of internal medicine at Southwestern Medical School in Dallas, said he hoped the F.D.A. would eventually ban the combined pain medicines like Percocet and Vicodin because patients in chronic pain end up taking more and more of the pills as they gain tolerance of the opioid component, not realizing that the resulting higher doses of acetaminophen are dangerous.
Half of all acetaminophen overdoses are in patients taking prescription medicines, and many over-the-counter medicines will soon contain more acetaminophen than prescription pills.
The agency has delayed action against the over-the-counter remedies, which would require a far more time-consuming and burdensome regulatory process than the one for prescription pills.
“We have not made a decision about what action or actions to take with regard to over-the-counter products,” Dr. Kweder told a news conference. “We’re continuing to consider our options along that line.”
While waiting for the F.D.A. to decide whether and how to act, drug manufacturers “can voluntarily choose not to make the extra strength” formulations, Dr. Kweder said.
But Marc Boston, a spokesman for Johnson & Johnson, said Extra Strength Tylenol and other high-dose formulations provided “many consumers with a safer alternative to other pain medicines.”
Dr. Sidney Wolfe, director of Public Citizen’s health research group, said the government’s inaction against high-dose, over-the-counter pills was inexcusable. “It’s been a year and a half since the advisory meeting,” he said. “What are they doing?”
Abbott Laboratories manufacturers Vicodin with doses of acetaminophen at 500, 650 and 750 milligrams – all of them over the new limit. “Abbott is evaluating the F.D.A.’s guidance and will determine how best to comply,” said Elizabeth Hoff, a company spokeswoman.