Opioid Warnings: Label Restrictions, Abuse Deterrence Guidance
FDA Brief: Week of Mar 21, 2016
Enhanced warnings for immediate-release (IR) opioid pain medications related to risks of misuse, abuse, addiction, overdose and death
- Continuing effort to educate prescribers and patients about the potential risks related to opioid use
- Class-wide safety labeling changes for IR opioid pain medication
- New boxed warning : serious risks of misuse, abuse, addiction, overdose, death
- Safety risk additional information
Draft Guidance on Abuse Deterrence Evaluation of Generic Oral Opioids
- For approval with ‘abuse deterrence’ in labeling
- Assessment of
- Routes of abuse
- Comparative in vitro studies and others(multiple strengths, PK)
- Data analysis
- Additional studies – Mechanical manipulation, Abuse by injection, ingestion, insufflation, smoking
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