WASHINGTON — Federal health regulators are limiting a key ingredient found in Vicodin, Percocet, and other prescription painkillers that have been linked to thousands of cases of liver damage each year.
The Food and Drug Administration said yesterday that it will cap the amount of acetaminophen in the drugs at 325 milligrams per capsule.
Acetaminophen is a ubiquitous pain reliever found in Tylenol, Nyquil, and thousands of other medicines used to treat headaches, muscle aches, and sore throats. The ingredient is also used at larger doses in prescription combination drugs that combine it with other 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 like Tylenol.
“The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a twenty-four hour period,’’ said FDA deputy director for new drugs, Dr. Sandra Kweder.
The restrictions announced yesterday will not affect over-the-counter products like Tylenol and Theraflu.
The FDA restrictions come more than a year and a half after a high-profile meeting in which a panel of 37 expert physicians narrowly voted to eliminate drugs like Vicodin completely.