Label Changes for:
Exalgo (hydromorphone HCl) Extended-Release Tablets
Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2012
- Avinza (morphine sulfate) Extended-Release Capsules
- Butrans (buprenorphine) Transdermal System
- Dolophine (methadone hydrochloride) Tablets
- Duragesic (fentanyl) Transdermal System
- Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules
- Exalgo (hydromorphone HCl) Extended-Release Tablets
- Kadian (morphine sulfate) Extended-Release Capsules
- Methadone hydrochloride Oral Solution and Concentrate
- MS Contin (morphine sulfate) Controlled-Release Tablets
- Nucynta ER (tapentadol) Extended-Release Oral Tablets
- Opana ER (oxymorphone hydrochloride) Extended-Release Tablets
- Oxycontin (oxycodone hydrochloride controlled-release) Tablets
FDA approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications. The REMS consists of a Medication Guide, elements to assure safe use, and a timetable for submission of assessments of the REMS. This REMS will use a single, shared system for the elements to assure safe use and the REMS assessments. This single shared system is known as the ER/LA Opioid REMS.
The updated labels include information on ER/LA prescription opioid analgesics abuse potential and risk of life-threatening respiratory depression, and consumer-friendly information on the safe use and disposal of ER/LA opioid analgesics.