02 Jul 2009 02:00 PM
FDA Panel Votes To Restrict Acetaminophen
An advisory committee to the US Food and Drug Administration (FDA) voted on Tuesday to recommend new restrictions on the popular pain
relief drug acetaminophen (known in many other countries as paracetamol), which is found in many US top selling over the counter medications such
as Tylenol, aspirin-free Anacin, Excedrin, and also in prescription drugs such as Vicodin and Percocet.
The FDA does not have to follow the recommendation of its advisory committees, but it usually does.
Altogether, the committee voted on 10 ways to restrict use of acetaminophen, including reducing the single adult dose and reducing the maximum daily dose of over the counter acetaminophen.
However, the most radical vote was to eliminate altogether some prescription products that combine acetaminophen with certain other drugs like narcotics, which means if the FDA follows this advice Vicodin and Percocet will no longer be available on prescription in the US.
The committee was also in favour of recommending the FDA require drug companies to put a black box warning, the highest there is, on labels of prescription drugs that contain acetaminophen combination products.
In another vote, the committee voted in favour of allowing only one concentration of acetaminophen to be sold in liquid over the counter formulations, as this should reduce the chances that parents will give their children the wrong dose.
The committee met earlier this week to discuss how to address the public health problem of liver injury linked to the use of acetaminophen over the counter and prescription products.
The FDA said there is no intention to remove the drug from the market altogether, since it plays an important role in treating pain and fever, and the risk of liver injury to people who use the drug in line with the product label instructions is very low.
But the widespread use of products containing the compound means that the number of people taking more than the recommended dose is high enough to be an important public health concern…
The FDA does not have to follow the recommendation of its advisory committees, but it usually does.
Altogether, the committee voted on 10 ways to restrict use of acetaminophen, including reducing the single adult dose and reducing the maximum daily dose of over the counter acetaminophen.
However, the most radical vote was to eliminate altogether some prescription products that combine acetaminophen with certain other drugs like narcotics, which means if the FDA follows this advice Vicodin and Percocet will no longer be available on prescription in the US.
The committee was also in favour of recommending the FDA require drug companies to put a black box warning, the highest there is, on labels of prescription drugs that contain acetaminophen combination products.
In another vote, the committee voted in favour of allowing only one concentration of acetaminophen to be sold in liquid over the counter formulations, as this should reduce the chances that parents will give their children the wrong dose.
The committee met earlier this week to discuss how to address the public health problem of liver injury linked to the use of acetaminophen over the counter and prescription products.
The FDA said there is no intention to remove the drug from the market altogether, since it plays an important role in treating pain and fever, and the risk of liver injury to people who use the drug in line with the product label instructions is very low.
But the widespread use of products containing the compound means that the number of people taking more than the recommended dose is high enough to be an important public health concern…

