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FDA moves to strengthen safety labeling for potent opioids

The FDA has announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting opioid analgesics intended to treat pain.

When finalized, the class-wide labeling changes will include important new language to help healthcare professionals tailor their prescribing decisions based on a patient’s individual needs, according to the FDA.

“The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” FDA Commissioner Margaret A. Hamburg, MD, said in a news release.

Hamburg said the FDA is resolved “to reduce the serious risks of long-acting and extended-release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.”

The updated indication states that extended-release and long-acting opioids are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The updated indication further clarifies that, because of the risks of addiction, abuse and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (such as non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.

Extended-release and long-acting opioid analgesics are not indicated for as-needed pain relief, the FDA noted.

“The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate prescribing, monitoring and patient counseling practices involving these drugs.”

Recognizing that more information is needed to assess the serious risks associated with long-term use of ER/LA opioids, the FDA is requiring the drug companies that make these products to conduct further studies and clinical trials. The goal of these postmarket requirements is to further assess the known serious risks of misuse, abuse, hyperalgesia, addiction, overdose and death.

The FDA also is requiring a new boxed warning on ER/LA opioid analgesics to caution that chronic use of these products during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening and require management according to protocols developed by neonatology experts. NOWS symptoms may include poor feeding, rapid breathing, trembling and excessive or high-pitched crying.

In addition, the FDA is notifying extended-release and long-acting opioid analgesic application holders of the need for changes to the following sections of drug labeling: Dosage and Administration; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information; and the Medication Guide.

Once the safety labeling changes are finalized, modifications will also be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy to reflect the updated information. Originally approved in 2012, the ER/LA Opioid Analgesics REMS requires companies to make available to healthcare professionals educational programs on how to safely prescribe extended-release and long-acting opioid analgesics and to provide medication guides and patient counseling documents containing information on the safe use, storage and disposal of such opioids.

The safety labeling changes “reflect the FDA’s current understanding of the risks and benefits of these products,” Throckmorton said. “The FDA will evaluate the results of the postmarket studies, continue to monitor relevant safety data and take further safety action, as warranted.”

More information: www.fda.gov/ForConsumers/ConsumerUpdates/ucm367660.htm.

By | 2013-09-11T00:00:00-04:00 September 11th, 2013|Categories: National|0 Comments

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