The FDA announced enhanced safety warnings for opioid pain medications related to the risks of misuse, abuse, addiction, overdose and death by requiring class-wide safety labeling changes for immediate-release (IR) opioid pain medications. These are among a number of steps the agency recently outlined in a plan to reassesses its approach to opioid medications. Among the required changes:

• A new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death.

• As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution for the chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening.

• Several additional safety labeling changes across all prescription opioid products will include additional information on the risk of these medications.

Citation: US Food and Drug Administration. FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death. March 22, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491739.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed March 28, 2016.

Commentary: Previously in this column we have discussed that deaths from prescription drug abuse have exceeded deaths from car accidents for young adults in many of the states in the United States. Recently the FDA released new guidelines (see http://www.familypracticenews.com/clinicaledge/clinical-guidelines/single-article/prescribing-opioids-for-chronic-pain/576519020cbcc0681b76511daec7f770.html) on the use of opioid medications for chronic pain. This new FDA warning underscores the need to be cautious in the use of opioid medications and the need to communicate the dangers of opioids to patients prior to use. —Neil Skolnik, MD