From the
Associated Press:
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.
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.
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.
And from
msnbc.com:
Government experts say prescription drugs like
Vicodin and
Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.
A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.
But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain.
In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.
Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to FDA data. Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.