FDA approves Risk Management and Mitigation Strategy for Extended-Release and Long-Acting Opioids

by Charles Miller

This July, the FDA approved a risk management and mitigation strategy (REMS) for extended-release and long-acting opioids used to treat chronic pain.

One of the goals of the REMS is the reduce serious adverse outcomes, including overdose deaths, from the inappropriate prescribing of ER/LA opiods.  Serious adverse reactions of ER/LA opioid analgesics include life threatening respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and death.  The REMS included a “blueprint” for prescriber education for ER/LA opioids.  A key feature of the blueprint is educating prescribers about proper initiation and modification of ER/LA opioids.  According to the blueprint:

  • Prescribers should have awareness of federal and state regulations on opioid prescribing.
  • Prescribers should be aware that:
    • Dose selection is critical, particularly when initiating therapy in opioid non-tolerant patients.
    • Some ER/LA opioid analgesics are only appropriate for opioid-tolerant patients.
    • Dosage should be individualized in every case.
    • Titration should be based on efficacy and tolerability.
  • Prescribers should be knowledgeable about when and how to supplement pain management with immediate-release analgesics, opioids and non-opioids.
  • Prescribers should be knowledgeable about converting patients from immediate-release to ER/LA opioid products and from one ER/LA opioid product to another ER/LA opioid product.
  • Prescribers should understand the concept of incomplete cross-tolerance when converting patients from one opioid to another.
  • Prescribers should understand the concepts and limitations of equianalgesic dosing and follow patients closely during all periods of dose adjustments.
  • Prescribers should understand the warning signs and symptoms of significant respiratory depression from opioids.
  • Prescribers should understand that tapering the opioid dose is necessary to safely discontinue treatment with ER/LA opioid analgesics when therapy is no longer needed.

Numerous patients have died from fatal respiratory depression when doctors started prescribed an initial dose of narcotic pain medications that exceeded the patient’s tolerance, increased the dose too quickly, or prescribed multiple pain medications that depress the central nervous system.

Examples of commonly prescribed extended release-and long-acting (ER/LA) opioids include:  Avinza (morphine sulfate ER capsules); Butrans (buprenorphine transdermal system); Dolophine (methadone HCl tablets); Duragesic (fentanyl transdermal system); Embeda (morphine sulfate ER-naltrexone capsules); Exalgo (hydromorphone HCl ER tablets); Kadian (morphine sulfate ER capsules); MS Contin (morphine sulfate CR tablets); Nucynta ER (tapentadol HCl ER tablets); Opana ER (oxymorphone HCl ER tablets); and OxyContin (oxycodone HCl CR tablets). (http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf.)

Pharmaceutical Liability Lawsuits Filed by Heygood, Orr & Pearson

If a loved one died from an accidental prescription drug overdose, you may be entitled to compensation from the prescribing doctor. The lawyers at Heygood, Orr & Pearson are available for a free legal consultation about your case. To find out if you are eligible, call us toll-free at 1-877-446-9001, or fill out our free online case evaluation form, and one of our representatives will contact you for more information.


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by Charles Miller

Charles Miller is a licensed attorney and a partner at Heygood, Orr & Pearson. Charles focuses his practice on areas of complex commercial litigation and personal injury litigation.