FDA adding warnings to opioids

FDA released new class-wide labeling changes for immediate-release (IR) opioid pain medications, including a boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. On a conference call Tuesday, Deputy Center Director of Regulatory Programs Douglas Throckmorton of FDA's Center for Drug Evaluation and Research said IR opioids represent 90% of the U.S. opioid market.

The new labeling will state that IR opioids should be prescribed only "for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated," FDA said. ...