FDA adds addiction, overdose, death to opioid warning labels

The new label requirements come a week after the CDC issued restrictive new guidelines meant to caution doctors who prescribe the highly addictive painkillers.

By Stephen Feller

BETHESDA, Md., March 22 (UPI) -- The U.S. Food and Drug Administration announced it will now require immediate-release opioid painkillers such as OxyContin and Vicodin to carry enhanced warnings about addiction, overdose and death as a result of misuse or abuse of the drugs.

The requirement is the second action a government agency has taken in a week against the growing epidemic of opioid abuse and addiction.


The new warnings include advice against suddenly stopping treatment because patients can easily develop a dependence on the drugs, as well as against use of the drugs by pregnant women because of concerns of neonatal opioid withdrawal syndrome.

The Centers for Disease Control and Prevention announced new guidelines for doctors on March 16 aimed at scaling back use of the drugs, including recommendations to use non-opioid painkillers unless they are not effective for patients.

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"Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids," Dr. Robert Califf, FDA commissioner, said in a press release. "Today's actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic."


The new rule requires opioids to be reserved for severe pain where non-opioids or opioid combination products are inadequate or not tolerated by patients. The labels also must include more details on patient dosing, changes to dosage, and not abruptly stopping the drug in patients who have developed a physical dependency.

Additionally, labels will include information on neonatal opioid withdrawal syndrome, which results from extended exposure to the drugs during pregnancy and requires newborns to be treated for a dependency.

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The FDA said it plans to revise label requirements as new research is presented on interactions with other drugs, including benzodiazepines.

"The FDA has taken an important step here," Dr. Bruce Psaty, a drug safety researcher at the University of Washington, told the New York Times. "This should help improve prescribing practices in the near term."

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