FDA expands the opioids covered by risk mitigation strategy

So-called "immediate-release" opioid pain medications will now be subject to more stringent requirements by the U.S. Food and Drug Administration (FDA) to help stem the tide of opioid misuse and abuse, according to a statement from FDA Director Scott Gottlieb, MD.

Of all opioid pain medications prescribed in the U.S. (160 million prescriptions a year), 90% are for immediate-release formulations, such as combinations of hydrocodone and acetaminophen or oxycodone and acetaminophen, Dr. Gottlieb noted. These pharmaceuticals are used to treat acute pain and are used in dental settings.

The FDA sent letters to 74 manufacturers of immediate-release opioid analgesics used in outpatient settings that their drugs will now be subject to a more stringent set of requirements under a Risk Evaluation and Mitigation Strategy, Dr. Gottlieb wrote.

This strategy requires that training be made available to healthcare providers who prescribe these pharmaceuticals. This training includes safe prescribing practices and consideration of nonopioid alternatives. While not mentioned explicitly in the statement, it is expected that dentists will be included in this mandatory training.

Previously, the FDA had set these requirements for extended-release opioid medications.