Warnings Added to Immediate-Release Opioids

"We know that there is persistent abuse, addiction, overdose mortality, and risk of NOWS associated with IR opioid products," said Dr. Douglas Throckmorton, M.D., deputy center director of regulatory programs at FDA's Center for Drug Evaluation and Research. "Today, we have taken an important next step in clarifying and making more prominent the known risks of IR opioid medications."

The U.S. Food and Drug Administration is requiring safety labeling changes for immediate-release (IR) opioid pain medications, including a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death. Its March 22 actions are part of FDA's plan to reassess its approach to opioid medications and reverse the epidemic of opioid medication abuse while still providing patients pain relief.

FDA is also requiring several additional safety labeling changes across all prescription opioid products that warn of the risk in these medications. "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 Dr. Robert Califf, M.D., FDA's commissioner. "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 updated indication clarifies that because of the risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (non-opioid pain relievers 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.

In 2013, the FDA required class-wide labeling changes for ER/LA opioid analgesics, including modifications to the products' indications, limitations of use, and warnings to more effectively communicate to prescribers the serious risks associated with them. FDA now is requiring similar changes to the labeling of IR opioid analgesics. "We know that there is persistent abuse, addiction, overdose mortality, and risk of NOWS associated with IR opioid products," said Dr. Douglas Throckmorton, M.D., deputy center director of regulatory programs at FDA's Center for Drug Evaluation and Research. "Today, we have taken an important next step in clarifying and making more prominent the known risks of IR opioid medications."

FDA also announced it is carefully reviewing available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids and, once the review is finished, will take necessary actions to ensure prescribers and the public are informed of the risks involved with their use.

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