The Rheumatologist
COVID-19 News
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Ankylosing Spondylitis Resource Center
    • Gout Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Systemic Lupus Erythematosus Resource Center
      • Rheumatoid Arthritis Resource Center
      • Gout Resource Center
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / The Risks of Opana Extended Release

The Risks of Opana Extended Release

April 17, 2017 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

At a two-day joint meeting of the U.S. Food and Drug Administration‘s (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSARM), committee members voted 18–8, with one abstention, that the benefits of Opana ER (oxymorphone hydrochloride) do not outweigh its public health risks.1 The health risks include recent HIV and hepatitis C virus (HCV) outbreaks, as well as vascular issues, related to intravenous abuse of this drug. An HIV outbreak in Scott County, Ind., which resulted from needle sharing among patients co-infected with HCV and HIV, has been linked to intravenous Opana use.2

You Might Also Like
  • FDA Requests Removal of Opana ER; Plus Abatacept’s New Dosing Option
  • Opana ER Pulled from U.S. Market
  • FDA Asks Endo to Withdraw Opana ER Opioid
Also By This Author
  • Drug Updates: EULAR 2012

Opana has a turbulent FDA regulatory history. The treatment was originally approved in 2006 to treat chronic pain. In 2011, the manufacturer, Endo Pharmaceuticals, reformulated the drug to make it harder to abuse. However, the new formulation never won abuse-deterrent labeling from the FDA. The manufacturer was also unable to stop generic versions of its initial formulation from becoming available, despite claiming the new version was safer. After the reformulation, 15 cases of thrombotic thrombocytopenic purpura were reported among injection-drug users who had recently injected reformulated Opana ER. This outbreak occurred in Tennessee in 2012 and was evaluated by and reported on by the Centers for Disease Control and Prevention.3 Additional case reports have been published.4

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

A number of FDA Advisory Committee members expressed their preference that the drug remain on the market with additional regulatory restrictions to mitigate its risks. Most of the panelists felt that revising and resubmitting the drug’s New Drug Application may resolve these issues. The manufacturer remains committed to reducing the potential abuse, misuse and diversion of its products.5


Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

References

  1. Fiore K. FDA joint panel votes down Opana ER: Too many risks with reformulated version tied to HIV, TTP clusters. 2017 Mar 15.
  2. Centers for Disease Control and Prevention. Community Outbreak of HIV Infection Linked to Injection Drug Use of Oxymorphone—Indiana, 2015. MMWR. 2015 May 1;64(16):443–444.
  3. Centers for Disease Control and Prevention. Thrombotic thrombocytopenic purpura (TTP)-like illness associated with intravenous Opana ER abuse-Tennessee, 2012. MMWR. 2013 Jan 11;62(01):1–4.
  4. Miller PJ, Farland AM, Knovich MA, et al. Successful treatment of intravenously abused oral Opana ER-induced thrombotic microangiopathy without plasma exchange. Am J Hematol. 2014 Jul;89(7):695–697. doi: 10.1002/ajh.23720. Epub 2014 Apr 15.
  5. Endo International Plc. News release: Endo statement on FDA advisory committees’ vote related to Opana ER. 2017 Mar 14.

Pages: 1 2 | Multi-Page

Filed Under: Analgesics, Drug Updates Tagged With: FDA, Food and Drug Administration, Opana ER, Opioid abuse, Opioids, public health

You Might Also Like:
  • FDA Requests Removal of Opana ER; Plus Abatacept’s New Dosing Option
  • Opana ER Pulled from U.S. Market
  • FDA Asks Endo to Withdraw Opana ER Opioid
  • The FDA Denies Approval for Remoxy Extended Release; Plus Knee OA Pain Treatment Moves into Phase 3 Trials

Simple Tasks

Learn more about the ACR’s public awareness campaign and how you can get involved. Help increase visibility of rheumatic diseases and decrease the number of people left untreated.

Visit the Simple Tasks site »

Meeting Abstracts

Browse and search abstracts from the ACR Convergence and ACR/ARP Annual Meetings going back to 2012.

Visit the Abstracts site »

Rheumatology Research Foundation

The Foundation is the largest private funding source for rheumatology research and training in the U.S.

Learn more »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2021 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.