WASHINGTON — Federal health regulators are limiting a key ingredient found in Vicodin, Percocet and other prescription painkillers that has been linked to thousands of cases of liver damage each year.
The Food and Drug Administration said Thursday that it will cap the amount of acetaminophen in the drugs at 325 milligrams per capsule. Current products on the market contain doses of up to 700 milligrams.
Acetaminophen is a ubiquitous pain reliever found in Tylenol, Nyquil and thousands of other medicines used to treat headaches, fever and sore throats. The ingredient is also used at larger doses in prescription combination drugs that mix it with narcotic drugs like oxycodone.
Those products are not dangerous by themselves but can cause toxic overdoses when patients combine them with a second acetaminophen-containing drug such as Tylenol.
FDA officials said the labeling on prescription drugs often does not make it clear that they contain acetaminophen, instead using abbreviations for the ingredient like “APAP.”
“One of the real challenges we have is that patients taking these products don’t know they’re taking acetaminophen at all,” said FDA deputy director for new drugs, Dr. Sandra Kweder, in a telephone briefing with reporters. “They don’t realize that they are overdosing.”
The FDA said it is working with pharmacies and other medical groups to develop standard labeling for acetaminophen, though that is not part of Thursday’s action.
Agency officials said the drugs will still be effective at lower doses.
“The amount of acetaminophen in these products has gradually crept up over the years,” Kweder said. “If you look at these products 20 to 30 years ago, many did not contain high doses of acetaminophen.”
Over-the-counter products
The restrictions announced Thursday will not affect over-the-counter products such as Tylenol and Theraflu. The FDA said it is still considering limits on those products, which involves a more complicated rule- making process than prescription products.
For now, over-the-counter products will actually be permitted to contain higher doses of acetaminophen — up to 500 milligrams per pill or capsule.
