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Lawmakers Urge FDA to Add Boxed Warning to Immediate-Release Opioids

Jun 11, 2015

Legislators are calling on the U.S. Food and Drug Administration (FDA) to add a boxed warning, or black box warning, to the label of immediate-release opioids. Regulatory Affairs Professionals Society (RAPS) reports that nearly two dozen Democratic legislators want a stronger warning to reflect "the serious risks of abuse" of the painkillers.

Lawmakers said their concerns are prompted by "the national public health crisis of prescription drug overdoses." according to a letter sent to FDA Acting Commissioner Stephen Ostroff on June 4, 2015. The legislators cited data from the Centers for Disease Control and Prevention (CDC) showing that opioid-related overdoses have risen 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).

A black warning is the strongest type of warning. The FDA currently requires a boxed warning for extended-release (ER) opioids and long-acting (LA) opioids, according to RAPS. The label on these drugs states: "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 and propose a stronger warning.

"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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