THURSDAY, Jan. 13 (HealthDay News) -- U.S. health officials
announced Thursday that they will lower the maximum amount of the
pain reliever acetaminophen allowed in prescription opioid products
such as Vicodin and Percocet because of reports of severe liver
Over a period of three years, the upper threshold of
acetaminophen in prescription drugs containing opioids such as
codeine will be set at 325 milligrams per dose. Right now, such
products can contain up to 750 milligrams of acetaminophen, Dr.
Sandra Kweder, deputy director of the Office of New Drugs in the
Center for Drug Evaluation and Research (CDER) at the U.S. Food and
Drug Administration, said during a Thursday news conference.
The FDA will also be mandating that such prescription
combination products include "black box" warnings on their labels
alerting users to the potential for liver damage.
"We're taking a major step in the agency's overall strategy to reduce the risk of intentional and unintentional liver damage that can occur if a patient takes too much of the common painkiller acetaminophen," Kweder said. "[But] let me also be clear that, when taken as directed, acetaminophen is a very safe product. Our goal is to make it even safer."
Patients already taking such products should not stop taking
them without consulting a health-care provider, she emphasized.
"There is no immediate threat to patients, even at the higher
dose," she said.
The new actions do not affect over-the-counter (OTC) products
containing acetaminophen such as Tylenol and Nyquil, although
Kweder said the agency is considering taking action in that area as
Right now, OTC products can contain up to 500 milligrams of the
ingredient with a limit of four doses per 24-hour period. These
products already carry warnings of possible liver damage on their
Overdoses from these prescription combination products account
for nearly half of all cases of acetaminophen-related liver damage
in the United States, according to Dr. Gerald Dal Pan, director of
CDER's Office of Surveillance and Epidemiology. "Many of [the cases
of liver damage] result in liver failure or death," he added.
Many of the 800 acetaminophen-related cases of liver injury each
year in the United States occur because a person is taking two
acetaminophen products at one time, often for two different
conditions such as back pain and migraine, and this can exceed the
recommended daily limit, he said. Combining acetaminophen with
alcohol can also be dangerous.
Although over-the-counter medications containing acetaminophen
clearly state the ingredients, prescription products are less
clear. Many patients may not know that the drug they're taking
contains acetaminophen and often they aren't warned to avoid other
Some 200 million prescriptions were dispensed for
acetaminophen/opioid prescription products in 2008, said Kweder,
who added that lower-dose versions of the drugs "won't be any less
These latest actions follow the advice of an FDA expert advisory
committee issued in June of 2009.
The FDA is encouraging patients to:
For more on the
affected acetaminophen-containing products, visit the FDA.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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