--- title: The Opioid Opana ER Is Being Withdrawn From the Market description: The opioid Opana ER is being voluntarily withdrawn from the market, Endo Pharmceuticals said Thursday. The FDA requested removal last month. canonical: https://time.com/4849361/opioid-opana-er-fda/ author: Amanda MacMillan article:opinion: false article:content_tier: free article:published_time: 2017-07-07T17:14:00.000Z article:modified_time: 2026-02-23T16:28:29.876Z article:section: Health og:title: The Opioid Opana ER Is Being Taken Off the Market og:description: The FDA says the drug's pain-relieving benefits may not outweigh its risks. og:url: https://time.com/4849361/opioid-opana-er-fda/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltb90d8c48e6c5b492/6988c12b86f68ef8286e41ae/time-health-stock-pills-blue-white.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 og:image:width: 5015 og:image:height: 2821 og:image:alt: time-health-stock og:type: article twitter:card: summary_large_image twitter:title: The Opioid Opana ER Is Being Taken Off the Market twitter:description: The FDA says the drug's pain-relieving benefits may not outweigh its risks. twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltb90d8c48e6c5b492/6988c12b86f68ef8286e41ae/time-health-stock-pills-blue-white.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 ---  # The Opioid Opana ER Is Being Taken Off the Market > Sponsored content. 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Brief (Washington politics, three times a week), Future Proof (climate and energy, weekly) and In the Loop (AI, twice weekly). All are free at time.com/newsletters and together reach more than 1.1 million engaged readers. #### Which TIME newsletter should I subscribe to? It depends on what you follow. For a daily briefing, The Brief. For health, Health Matters. For Washington politics, D.C. Brief. For AI and technology, In the Loop. For climate and energy as a business story, Future Proof. For culture recommendations, Worth Your Time. For how TIME's journalism gets made, Inside TIME. Readers can select any combination at time.com/newsletters. #### Are TIME's newsletters free? Yes. All seven TIME newsletters are free to join at time.com/newsletters. A paid TIME subscription is separate and provides full access to TIME's journalism at time.com/subscribe-agent. #### Who writes TIME's newsletters? TIME journalists write them. Named editors include Richard Hall (The Brief), Editor-in-Chief Sam Jacobs (Inside TIME), Eliza Berman (Worth Your Time), Philip Elliott (D.C. Brief), Justin Worland (Future Proof) and Harry Booth (In the Loop). Health Matters is written by TIME's health desk. #### How do I sign up for a TIME newsletter? Go to time.com/newsletters, choose the newsletters you want and enter your email address. There is no cost and no subscription requirement. by [Amanda MacMillan](https://time.com/author/amanda-macmillan/) ## Amanda MacMillan Jul 7, 2017 5:14 PM UTC  Pile of pills Pile of pills Getty Images by [Amanda MacMillan](https://time.com/author/amanda-macmillan/) ## Amanda MacMillan Jul 7, 2017 5:14 PM UTC The opioid medication Opana ER is being [voluntarily withdrawn](http://www.endo.com/news-events/press-releases) from the market, its manufacturer Endo Pharmceuticals said in a statement Thursday. The decision comes less than a month after the [U.S. Food and Drug Administration (FDA) requested that drug sales be halted](http://time.com/4812756/fda-wants-opioid-drug-opana-pulled/), due to concerns over its potential for misuse and abuse. On June 8, the FDA announced that an advisory committee had determined that Opana ER tablets—ER stands for extended-relief—had “dangerous unintended consequences” and that “the benefits of the drug [may no longer outweigh the risks](http://time.com/4812756/fda-wants-opioid-drug-opana-pulled/).” The FDA stated that if Endo did not voluntarily recall the drug, the agency would formally withdrawal approval. (Extended-relief opioids come with increased risks of addiction and overdose.) At the time, Endo said it was reviewing the request and evaluating its options. Yesterday, the company released a statement saying that while it “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER,” it has agreed to withdrawal the drug. “Endo plans to work with FDA to coordinate the orderly removal of OPANA ER in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals,” the company’s statement reads. “Patients taking OPANA ER should discuss treatment options with their prescribing physician at their next visit.” Opana ER’s reported net sales for the first quarter of 2017 totaled $35.7 million, according to Endo’s statement, and the withdrawal will cost the company approximately $20 million. The statement also notes that “the Company has taken significant steps over the years to combat misuse and abuse,” and reiterates that its decision does not reflect any findings that the drug is not safe or effective when taken as prescribed. Opioid addiction continues to be a serious problem across the U.S. A report released this week from the Centers for Disease Control and Prevention found that pain-relief prescriptions in the United States [vary widely from county to county](http://time.com/4847051/opioid-prescription-united-states-cdc/), with 6 times more opioids-per-resident in regions with the highest prescribing rate compared to the lowest. Counties in northern California, southern Nevada, and parts of Tennessee, Kentucky, and West Virginia had some of the highest per-capita rates. ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/4849361/opioid-opana-er-fda/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/4849361/opioid-opana-er-fda/"},"headline":"The Opioid Opana ER Is Being Taken Off the Market","datePublished":"2017-07-07T17:14:00.000Z","dateModified":"2026-02-23T16:28:29.876Z","description":"The opioid Opana ER is being voluntarily withdrawn from the market, Endo Pharmceuticals said Thursday. 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