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Label Changes for:

Nucynta ER (tapentadol) Extended-Release Oral Tablets

July 2012

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.


[July 2012 - Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids - FDA]