FDA panel recommends smaller doses of painkillers
Posted June 30, 2009
ADELPHI, Md. — Government experts say the maximum dose listed for Tylenol and dozens of other painkillers should be reduced to help curb deadly overdoses.
In a series of votes Tuesday, a Food and Drug Administration panel endorsed lowering the maximum dose of over-the-counter acetaminophen – the key ingredient in Tylenol, Excedrin and other medications. But panelists rejected a proposal to pull NyQuil, and other cold and cough medicines that combine acetaminophen with other drugs, off the market because of their role in overdosing.
Acetaminophen is one of the most widely used drugs in the U.S. Many patients find it easier on the stomach than other painkillers like ibuprofen and aspirin, which can cause ulcers.
But despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.
“We see patients all the time with Tylenol toxicity,” said. Dr. Theodore Bania, of St. Luke’s Roosevelt Hospital Center in New York.
Bania said taking too much acetaminophen is an easy to make the mistake. For example, if a patient takes Tylenol for a headache as well as a cold medicine with acetaminophen they are overdosing.
FDA's experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.
The group was not asked to recommend an alternative maximum daily dose.
The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson's Extra Strength Tylenol is 1,000 milligrams, or two tablets.
In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.
However, some experts complained the measure would create unnecessary work for doctors and patients.
"I think the drain on the health care system, which is already strained, would be enormous," said Dr. Robert Kerns of Yale University.
The FDA is not required to follow the group's advice, though it usually does.
Panelists are scheduled to vote later Tuesday on a series of safety restrictions for the drugs – including changes to packaging and labeling.
The experts rejected a proposal to pull certain cold and cough medicines off the market. The FDA says patients often pair combination drugs, like Procter & Gamble's NyQuil or Novartis' Theraflu, with pure acetaminophen treatments, like Tylenol, exposing themselves to unsafe levels of the drug.
But panelists cited FDA data that said the medications play a minor role in acetaminophen overdoses, with only 10 percent of acetaminophen-related deaths involving a cold and cough product.
"I don't think we should be advocating a solution to a problem that really is not there," said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.
The panel voted 24-13 to keep the products on the market.
A recall of combination cold medicines could have cost manufacturers hundreds of millions of dollars in revenue. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products, according to IMS Health, a health care analysis firm.