FDA Mandates Major Labeling Changes on Opioid Pain Medication

The Food and Drug Administration is requiring pharma companies selling opioid pain medications to “better emphasize and explain the risks associated with their long-term use” on medication labels, the Department of Health and Human Services (HHS) said in a July 31 statement.
“These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients who use opioids over long periods,” the department said.
Drug labels must now show clearer risk information, describing a summary of study results showing estimated risks of addiction, overdose, and misuse of the medication over the long term….