Regulatory Focus™ > News Articles > Legislators Press FDA to Add Black Box Warning to Immediate-Release Opioids

Legislators Press FDA to Add Black Box Warning to Immediate-Release Opioids

Posted 08 June 2015 | By Alexander Gaffney, RAC 

Legislators Press FDA to Add Black Box Warning to Immediate-Release Opioids

A group of nearly two dozen Democratic legislators is calling on the US Food and Drug Administration (FDA) to label immediate-release opioids with more serious warnings meant to reflect "the serious risks of abuse" associated with the drug.

In a letter sent on 4 June 2015 to FDA Acting Commissioner Stephen Ostroff, the legislators said their concerns are driven by "the national public health crisis of prescription drug overdoses." Opioid-related overdoses and deaths have increased four-fold since 2000, the legislators noted, citing data from the Centers for Disease Control and Prevention (CDC).

The legislators also said they were concerned about the significant increase of neonatal abstinence syndrome (NAS), which is caused when a child is born addicted to opiates due to drug use by the mother during pregnancy.

Black Box Warning Proposals

In response to these ongoing problems, the legislators' letter proposes strengthening the labeling for immediate-release (IR) opioids to make them more similar to the labeling for extended-release (ER) opioids.

At present, FDA requires all ER and long-acting (LA) opioid analgesics to bear a black box warning indicating the serious risks associated with use of the drug. It reads:

"WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTION."

"However," the legislators explain, "FDA chose to apply this black box warning only to ER and LA opioid analgesics"—not IR opioids. The letter goes on to argue that new evidence now supports extending the black box warning to IR opioid analgesics as well.

"A recent systematic review by the Agency for Health Research and Quality (AHRQ) did not identify a single study that found statistically significant differences between short versus long-acting opioids on the risks of overdose, addiction, abuse or misuse in patients with chronic pain," the legislators wrote.

The lawmakers also noted that, by some recent estimates, 91% of all outpatient opioid prescriptionss are for IR formulations.

"Given the established risk of addiction, abuse and overdose from all opioid analgesics, as well as the emerging public health threat of NAS, we believe that the FDA should ensure that all IR opioid formulations bear the same black box warning as the ER/LA formulations," the legislators concluded. "We believe that this information is crucial to patients and prescribers."

 

Letter to FDA

Categories: Regulatory News

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