House Panel Seeks Black Box Warning for Opioid Prescriptions

June 12, 2015

Democratic members of the House Energy & Commerce Committee are pressing the FDA to expand the black box warning on extended-release opioids to include immediate-release versions of the painkillers as well.

In a letter to FDA Acting Commissioner Stephen Ostroff, the 22 committee Democrats argue that the evidence linking opioid prescribing to serious health risks does not distinguish IR formulations from the ER formulations in terms of health outcomes.

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

The congressmen also note a four-fold rise from 2004 to 2013 in the incidence of babies born addicted to opioids as a result of their mothers’ use. The legislators cite recent estimates that 91 percent of all outpatient opioid prescriptions are IR formulations. One of those, hydrocodone acetaminophen, was the most widely prescribed drug to Medicare beneficiaries in 2013, the June 4 letter says.

The lawmakers want Ostroff to respond by June 29. Read the letter at www.fdanews.com/06-15-letter.pdf. — John Bechtel