FDA on the Option to Reduce Painkiller Overdoses
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Jessica SmagaczJuly 01, 2009 12:57 AMThis past Monday, AP reported that the makers of Tylenol, Excedrin and other medications attempted to dissuade regulators from placing new restrictions on painkillers, including the possibility of removing some of them from store shelves.
35 experts were organized by the FDA to attend a two-day meeting in order to discuss ways to prevent overdose with acetaminophen.
Acetaminophen is the pain-relieving, fever-reducing ingredient in Tylenol and some other prescriptions and over-the-counter medications.
Currently, acetaminophen is “the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.”
Please see our past post: FDA will Discuss Liver Risks with Tylenol & other Painkillers.
FDA asked its experts to consider a range of options:
-Adding a “black box” warning label to the products
-Lowering the drug dosage in some products or
-Pulling certain types of medications off the market
Companies such as the industry group that represents Johnson & Johnson defended the products “saying they pose a relatively small risk to patients.”
“Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.”
Although the FDA is not required to follow the advice of its panels, it usually does. This panel vote was supposed to occur earlier today.
According to AP, FDA is making it clear that it “will not play king-maker in the market for over-the-counter medications.”