FDA wants painkiller Opana ER pulled off market
The US Food and Drug Administration said Thursday that drugmaker Endo Pharmaceuticals must remove its powerful opioid Opana ER from the market. The agency says this the first time it has asked that an opioid pain medication be pulled due to "the public health consequences of abuse." (Source: CNN.com - Health)
Source: CNN.com - Health - June 8, 2017 Category: Consumer Health News Source Type: news
' Wow.' In A First, FDA Requests An Opioid Be Pulled From The Market
In a dramatic first, the Food and Drug Administration is requesting that Endo Pharmaceuticals remove the opioid Opana ER from the market because of its potential for causing abuse. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - June 8, 2017 Category: Pharmaceuticals Authors: Matthew Herper, Forbes Staff Source Type: news
FDA Asks Endo Pharma to Take Opana ER Off the Market FDA Asks Endo Pharma to Take Opana ER Off the Market
For the first time, the FDA has asked a company to remove a currently marketed opioid pain medication from the market because of the public health consequences of abuse.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 8, 2017 Category: Consumer Health News Tags: Neurology & Neurosurgery News Alert Source Type: news
FDA Wants Opana ER Off the Market
(MedPage Today) -- Marks first time agency has sought to pull an opioid due to abuse potential (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - June 8, 2017 Category: Psychiatry Source Type: news
FDA asks Endo to withdraw Opana ER opioid; shares fall
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Thursday it has asked Endo International Plc to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company's shares down more than 12 percent. (Source: Reuters: Health)
Source: Reuters: Health - June 8, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
FDA Requests Removal of Opana ER for Risks Related to Abuse
June 8, 2017 -- Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 8, 2017 Category: Pharmaceuticals Source Type: news
Endo shares plummet as FDA requests removal of pain drug Opana ER
(Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - June 8, 2017 Category: Pharmaceuticals Source Type: news
FDA asks Endo to withdraw Opana ER opioid, shares fall
(Reuters) - The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company's shares down as much as 13 percent. (Source: Reuters: Health)
Source: Reuters: Health - June 8, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
FDA requests removal of Opana ER for risks related to abuse
Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 8, 2017 Category: American Health Source Type: news
FDA Calls On Drugmaker To Pull A Powerful Opioid Off The Market
The U.S. Food and Drug Administration (FDA) is calling on Endo Pharmaceuticals to stop selling a specific opioid painkiller, Opana ER, due to the "public health consequences of abuse." This is the first time the FDA has acted to remove an opioid from the market, citing the frequent misuse of the drug and associated outbreaks of HIV, hepatitis C, and another serious but less well-known blood disorder called thrombotic microangiopathy. Endo Pharmaceuticals released a statement highlighting their efforts to prevent abuse of the drug and stating that they are reviewing the FDA's request. (Source: News stories via the Rural Assistance Center)
Source: News stories via the Rural Assistance Center - June 8, 2017 Category: Rural Health Source Type: news
FDA Panels Say Risks of Opana ER Outweigh Benefits FDA Panels Say Risks of Opana ER Outweigh Benefits
Members of the FDA ' s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees conclude the abuse-deterrent oxymorphone ' s risks now outweigh its benefits.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - March 17, 2017 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news
FDA Advisers: Opana's Benefits Don't Outweigh Its Risks (FREE)
By Amy Orciari Herman
Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM
The benefits of the opioid painkiller Opana ER — an extended-release version of oxymorphone — do not … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - March 15, 2017 Category: Primary Care Source Type: news
FDA panel: Endo opioid painkiller's risks outweigh its benefits
A Food and Drug Administration panel found, in an 18-8 vote, that the benefits of a newer formulation of Endo International ’s Opana ER — an extended-release, opioid pain medicine — no longer outweigh its risks.
The FDA’s Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees is reviewing oxymorphone products such as Opana ER because of the high abuse rate of such medicines. The FDA will make the final decision on whether to take any regulatory action… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - March 15, 2017 Category: Health Management Authors: John George Source Type: news
FDA Panel: Painkiller Opana ER Benefits No Longer Outweigh Risks
The benefits of an opioid painkiller linked to a 2015 HIV outbreak in Indiana no longer outweigh the risks, a panel of advisers to the U.S. Food and Drug Administration concluded Tuesday. (Source: WSJ.com: Health)
Source: WSJ.com: Health - March 15, 2017 Category: Pharmaceuticals Tags: PAID Source Type: news
FDA Joint Panel Votes Down Opana ER
(MedPage Today) -- Too many risks with reformulated version tied to HIV, TTP clusters (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - March 15, 2017 Category: Psychiatry Source Type: news
