A Healthesystems publication

Spring 2014

FDA Actions Address Acetaminophen Toxicity Risks

The FDA recognized the risks of high doses of acetaminophen by asking prescription drug manufacturers to lower the maximum content per pill or capsule by January 2014. The request did not apply to over-the-counter preparations, so risks will remain until all the supplies of all high-content formulations are depleted.

In high doses, acetaminophen can cause toxicity and lead to serious liver damage or even death. In 2011, the National Council for Prescription Drug Programs (NCPDP), FDA and other interested parties focused attention on patient safety issues with the formation of the Acetaminophen Best Practices Task Group.1

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SOURCES

1 -U.S. Food and Drug Administration. Rockville, MD. Acetaminophen Information. http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm165107.htm. February 22, 2014.
2 -U.S. Food and Drug Administration. Rockville, MD: FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure. http://www.fda.gov/drugs/drugsafety/ucm239821.htm. February 22, 2014.
3 -U.S. Food and Drug Administration. Rockville, MD. FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers. http://www.fda.gov/Drugs/DrugSafety/ucm381644.htm. February 22, 2014.
4 -U.S. Food and Drug Administration. U.S. Food and Drug Administration. Rockville, MD. Acetaminophen Information. http://google2.fda.gov/search?q=acetaminophen&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*. February 22, 2014.
5 -U.S. Food and Drug Administration. Rockville, MD. Questions and Answers on Final Rule for Labeling Changes to Over-the-Counter Pain Relievers. http://www.fda.gov/drugs/newsevents/ucm144068.htm.
6 -U.S. Food and Drug Administration. Rockville, MD. Questions and Answers on Final Rule for Labeling Changes to Over-the-Counter Pain Relievers. http://www.fda.gov/drugs/newsevents/ucm144068.htm. February 22, 2014.
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