Immediate-Release Opioids Should have Boxed Warning, Lawmakers Say

A boxed warning, the most serious type of warning, should be placed on immediate-release (IR) opioids, legislators say. Regulatory Affairs Professionals Society (RAPS) reports that a group of two dozen Democratic legislators sent a June 4, 2015 letter to FDA Acting Commissioner Stephen Ostroff proposing a stronger label to reflect “the serious risks of abuse” associated with the pain killers. Concerns were fueled by “the national public health crisis of prescription drug overdoses.” the letter said.

Legislators cited data from the Centers for Disease Control and Prevention (CDC) showing that opioid-related overdoses have gone up four-fold since 2000. There are also concerns related to neonatal abstinence syndrome (NAS); this is when opioid use during pregnancy causes newborns to be born addicted to the drugs.

The FDA already requires a boxed warning for extended-release (ER) opioids and long-acting (LA) opioids, RAPS reports. The label reads: “Warning: Addiction, abuse and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; interaction with alcohol; and cytochrome P450 interaction.” The letter points out that “FDA chose to apply this black box warning only to ER and LA opioid analgesics” and not IR opioids.

The lawmakers point to new evidence in support of a stronger warning for IR opioids. “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 letter states. According to the legislators, some estimates indicate that IR formulations account for 91 percent of all outpatient opioid prescriptions.

“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 lawmakers stated. “We believe that this information is crucial to patients and prescribers.”

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