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FDA to require more warning labels to prescription pain medications

Staff writer |
The U.S. Food and Drug Administration (FDA) announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications.

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Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Those actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications.

The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications.

This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.

“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,” said Robert Califf, M.D., FDA commissioner.

The updated indication clarifies that because of these risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated.

The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient.

As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts.

NOWS may occur in a newborn exposed to opioid drugs for a prolonged period while in utero.

Additionally, the FDA is requiring updated labeling for all opioids to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome.


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