Lawmakers Call on FDA to Add Boxed Warning for Immediate-Release Opioids

Immediate-release (IR) opioids should carry a boxed warning on their labels, a group of nearly two dozen legislators said in a letter to the U.S. Food and Drug Administration (FDA). According to Regulatory Affairs Professionals Society (RAPS), the lawmakers want the label to reflect “the serious risks of abuse” associated with the painkillers. A boxed warning, also referred to as a black box warning, is the strongest type of warning.

Lawmakers sent a June 4, 2015 letter to FDA Acting Commissioner Stephen Ostroff indicating that their concerns are prompted by “the national public health crisis of prescription drug overdoses.” The letter cited data from the Centers for Disease Control and Prevention (CDC) showing that opioid-related overdoses have gone up four-fold since 2000. Additionally, there are concerns about babies being born addicted to opiates due to use during pregnancy; this is referred to as neonatal abstinence syndrome (NAS).

The letter points out that the FDA mandates boxed warnings 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.” Legislators point out that “FDA chose to apply this black box warning only to ER and LA opioid analgesics” and not IR opioids.

The legislators propose a stronger warning, and point to new evidence as support. “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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