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Prescription Acetaminophen/Opioid Combinations: Making Pain Medicines Safer

March 5, 2020

This is an important drug
safety update from the U.S. Food and Drug
Administration. FDA announced that
prescription combination pain medicines
containing an Opiate and Acetaminophen can no
longer contain more than 325 milligrams of
Acetaminophen per tablet or per capsule. In addition, manufacturers
of these medicines must update their labels to
include warnings about the potential risk of
severe liver injury. Acetaminophen is one of
the most commonly used drugs for treating
pain and fever. It’s in many prescription
products in combination with Codeine and
other Opiates. You might know some of
these as Percocet or Vicodin; it’s also in many
prescription medicines to treat cough and migraines. Most cases of severe liver
injury in association with Acetaminophen occurred in
patients who took more than the recommended
amount in a 24 hour period or they took more than
one product containing Acetaminophen at the
same time or they took Acetaminophen
with alcohol. FDA is taking this action
to make medications containing Acetaminophen
safer for patients. Overdoses from
prescription products containing Acetaminophen
account for nearly half of all cases of Acetaminophen
related liver failure in the United States, many
of which result in liver transplant or death. This is the first in a
multi-step approach to this important
public health issue. Prescription combination
medications containing an Opiate and 325 milligrams
of Acetaminophen are effective in treating pain
and are already widely used. You can find more
information about this announcement including
a Q&A for consumers by visiting our website at

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