FDA announces strongest warnings for opioid pain medications

The US Food and Drug Administration has announced class-wide safety labelling changes for immediate release (IR) opioid pain medications. The FDA now requires a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death.

These changes reflect the agency’s new policy regarding opioid medications, with the aim of reversing the risks associated with opioids while still providing patients in pain access to effective relief.

The FDA is also requiring several additional safety labelling changing across prescription opioid products to include information on the risks associated with these treatments.

Robert Califf, the recently appointed commissioner of the FDA, comments: “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. 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.”

This update clarifies the FDA’s position on opioids, which indicates that IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options 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.

Additionally, the FDA now requires a boxed warning on IR opioid analgesics that indicates that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life threatening if not recognised and treated using protocols developed by neonatology experts. NOWS can occur in a newborn exposed to opioid drugs for a prolonged period while in utero.

Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, says: “The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board. We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids.”

The FDA indicates that this is the latest step in its commitment to combat an emerging public health crisis which has a profound impact on individuals, families and communities across the country. A full list of the opioids, including Tylenol, Demerol and Vicodin, can be found here.

Sean Murray