FDA: New Indication, Boxed Warning for All ER/LA Opioids

The FDA announced that class-wide safety labeling changes and new postmarket study requirements are in place for all extended-release (ER) and long-acting (LA) opioid analgesics intended to treat pain.

The finalized class-wide labeling changes will include new language to help healthcare professionals guide their prescribing based on patients’ individual needs.

RELATED: Pain Management Resource Center

Some of the major updates include:

Indications: ER/LA 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

  • Drugs should be reserved for use in patients for whom alternative treatment options (eg, non-opioid analgesics, or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management
  • ER/LA opioid analgesics are not indicated for as-needed pain relief

New Boxed Warning: Chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening and require management

  • Symptoms of NOWS include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying

Other affected fields: Dosage and Administration, Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information, and the Medication Guide

Further changes will also be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) to reflect the updated information.

Drug companies that manufacture ER/LA opioids will be required to conduct further studies and clinical trials to assess the serious risks associated with long-term use of these drugs (eg, hyperalgesia, addiction, overdose, death).

For more information call (888) INFO-FDA or read the New Safety Measures Announced for ER/LA Opioids.