The opioid medication Opana ER is being voluntarily withdrawn from the market, its manufacturer Endo Pharmceuticals said in a statement Thursday.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, 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.” 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, 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.
Discover How Laminine™ Can Improve Your Health... Watch The Video Above!
Laminine™ Will Help Anyone. The Benefits, When Taken Regularly May Include...
Make 2017... the Year You Improve Your Health!
Join Thousands in 42 Countries
(shown at the bottom of this page) Who Are Already Seeing Amazing Health Benefits from
Regular Use of Laminine™ & Laminine™ Omega Plus!
"The Happy Pill"
Laminine™ is a
Natural, Synergistic SuperFood
that contains 22 amino
acids, trace minerals, vitamins and Fibroblast Growth Factor (FGF)
The perfect combination of life-giving sustenance sourced from land, sea
Its source is from the "Miracle of
Clinical Studies have been conducted which showed Laminine's™ positive effects on Physical, Mental, Emotional Strengths and Overall Health. Laminine™ is an all Natural Product
CLICK HERE To Join My Group & Order (Wholesale) & Choose the "Laminine™ Activation Pack"
After Clicking on One of the Links Below, Just CLICK the "Click Here to Agree and Continue" Button in the "Informed Consent and Participation Agreement" Form... to Begin Your Own Personal Q & A Session on How Laminine and Laminine Omega +++ Can Help You Achieve PERFECT Health.