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FDA Panel Recommends Removal of VicodinTM and PercocetTM
On June 30, 2009, a government advisory panel recommended the elimination of prescription
drugs that combine acetaminophen with narcotics, such as Vicodin™ and
Percocet™. The panel, assembled by the Food and Drug Administration,
voted 20 to 17 to advise the FDA to remove these combination prescription drugs
from the market due to their risk for overdose and severe liver injury (http://www.cnn.com/2009/HEALTH/06/30/acetaminophen.fda.hearing/index.html).
The FDA panel’s meeting involved recommendations for reducing the risk of adverse
events with acetaminophen, a drug found not only in combination prescription drugs
but also in over-the-counter medications such as Tylenol® and NyQuil® . The panel
also focused on the daily doses of acetaminophen in over-the-counter and prescription
medications in addition to the formulations and dosing recommendations for children.
A second panel vote involved the recommendation for including boxed warnings on
the prescription combination drugs. Although the FDA is not required to follow the
recommendations of its advisory panels, the agency typically does.
Cerilliant offers certified reference standards of native and labeled acetaminophen,
hydrocodone, and oxycodone, components of the combination prescription drugs Vicodin™
and Percocet™. We also provide a wide selection of over-the-counter (OTC) drugs,
including their metabolites and internal standards, as well as a new certified multi-component
spiking solution standard of 6 common drugs found in OTC medications (O-034). These
pharmaceutical and clinical drug solutions are suitable for a variety of uses, such
as pharmaceutical, clinical or toxicology analysis, system suitability, urine drug
testing, isotope dilution methods, or calibrator preparation. Click on the links
below to view our comprehensive list of OTC and opiate certified spiking solution
standards:
Cerilliant Certified Reference Solutions of OTC Drugs
Cerilliant Certified Reference Solutions of Opiate Drugs
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