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FDA proposes more visible warning labels on pain relievers to prevent overdoses
The new labels would contain information on liver damage, stomach bleeding and alcohol warnings.
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Over-the-counter pain relievers could carry stronger warnings under a recent FDA proposal.
Raymond Woosley, MD, president of the Critical Path Institute in Tucson, Ariz., said the data on the risks associated with over-the-counter (OTC) pain relievers has been in the literature since the 1970s.
"People have known that overdose of these drugs would just melt your liver," Woosley said in an interview. "The FDA is saying that although they have not had the resources to look at these things before, the data are now crystal clear."
The FDA will amend labeling regulations on internal analgesic, antipyretic and antirheumatic drug products. These agents are commonly known as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs).
Liver toxicity warnings
Under the new regulations, products containing acetaminophen would require new warnings that highlight the potential for liver toxicity, particularly when using acetaminophen in high doses, when taking more than one product with acetaminophen and when taking acetaminophen products with the intake of moderate amounts of alcohol.
"Clearly the more you drink, the more risk you are going to have from acetaminophen, but nondrinkers have a risk of liver disease as well," Woosley said.
A further regulation would require that the ingredient acetaminophen be prominently displayed on the product's principal display panel of the immediate container and the outer carton, if applicable.
For NSAIDs, the regulations will require highlighting the potential for stomach bleeding among people aged 60 and older, as well as among patients who have had prior bleeding or ulcers, take a blood thinner, are taking multiple nonsteroidal anti-inflammatory products or take these products for an extended period. Risks associated with alcohol use must also be highlighted.
The name for the nonsteroidal anti-inflammatory ingredients must also be prominently displayed on the principal display panel of the immediate container and the outer carton, if applicable.
The new labeling would apply to all OTC drug products that contain only an internal analgesic, antipyretic and antirheumatic ingredient with other ingredients, such as cold symptom relievers.
According to documents provided by the FDA, consumers may also be taking internal analgesic, antipyretic and antirheumatic ingredients in their prescription medications, which makes it important to alert them to the contents of their OTC medications.
"This decision will be a big help, because many times patients do not even understand that when they take two different products they may have the same active ingredient. The number of products that contain acetaminophen is huge," Woosley said. "If nothing else, changing the font size would help."
This article also appeared in Infectious Disease News, a SLACK Incorporated publication.
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