The amount of acetaminophen found in prescription painkillers like
Vicodin and Percocet presents a serious risk of liver damage for
patients who take too much of these medications, and the U.S. Food and
Drug Administration (FDA) is taking action. The agency is ordering
manufacturers of these drugs to limit the per-pill level of
acetaminophen to 325 milligrams, which is the same amount of
acetaminophen that can be found in one regular-strength Tylenol pill,
available over the counter. The new restrictions apply to a number of
popular prescription painkillers -- including Vicodin and Percocet, and
their generic versions -- which may contain as much as 700 milligrams of
acetaminophen per dose.
Patients who are prescribed these drugs
(often in the short term as part of recovery from an injury or medical
procedure) put themselves at serious health risk if they take too much
at once, because an overdose of acetaminophen can cause severe liver
damage. According to the FDA, the greatest danger to patients occurs
when they take more than the prescribed dose of acetaminophen, take more
than one acetaminophen-containing product at once (e.g. combine
prescription and over-the-counter drugs), or when patients drink alcohol
while taking acetaminophen. The dangers presented by overdose of
acetaminophen have been under the microscope for some time, since liver
failure caused by acetaminophen accounts for about 400 deaths each year
in the United States. In 2009, after looking at the dangers of
acetaminophen-combination prescription drugs, an FDA advisory panel
recommended that Vicodin and similar drugs be removed from the market
altogether.
As part of the new restrictions on
acetaminophen-combination painkillers (the changes will be implemented
over the next three years), the FDA is also requiring manufacturers of
these drugs to include a black box warning label on packaging materials
advising patients of the risk of severe liver injury associated with the
medications.
For everything you need to know about acetaminophen and the new FDA restrictions, visit the FDA website at www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm. And to learn more about legal issues related to drug safety, check out Nolo's articles Product Liability Claims Involving Pharmaceutical Drugs and FDA Drug Recalls.
Effective Date: January 13, 2011
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