The maker of opioid painkiller Opana ER is pulling the drug off the market at the request of federal regulators because it’s being abused. Opioid Opana ER, approved in 2006, is too risky, the FDA says. Currently, there are no generic versions on the market.
Endo International PLC said recently that it will voluntarily stop selling the pills, approved for use in patients with severe, constant pain, after consulting with the U.S. Food and Drug Administration. It’s the first opioid drug that the FDA has sought to remove from the market due to abuse.
Opana ER is a powerful painkiller, about twice as powerful as OxyContin, another often abused opioid. Endo said it had worked for years to “combat misuse and abuse.” The drug was intended to be used to manage moderate to severe pain over a long period with just one pill. But addicts crushed it to get a massive high all at once.
So, the company made the tablets with a coating that made them hard to crush. It also changed the formula in 2012. The FDA said post-market data suggested that after the company reformulated the medication, people were injecting it more than they were snorting it.
Besides contributing to overdoses, abuse of Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles, according to the FDA. The agency asked the company to stop selling Opana ER after its advisers reviewing its safety at a March hearing, voted 18-8 against keeping it on the market.
Endo sold $35.7 million worth of Opana ER in the first three months of 2017 and $158.9 million last year. The company will work with the FDA on a timeline to remove the drug from the market while giving patients and doctors the chance to find new treatments.
According to the US Centers for Disease Control and Prevention, the United States is in the midst of an opioid overdose epidemic. Opioid overdose killed more than 33,000 people in 2015, more than any year on records. Nearly half of all overdose deaths involve some kind of prescription drug.
As a partner with D'Arcy Johnson Day, Andrew D'Arcy has been involved in some of the nation’s most high-profile cases and investigations. His practice includes serious automobile accidents, medical malpractice, wrongful death and product defect cases. Andrew has been personally responsible for numerous multi-million dollar settlements and verdicts on behalf of his clients. He has been recognized by his peers as an "AV" rated attorney, the highest possible rating given by Martindale-Hubbell publication. Andrew has been named a "Super Lawyer" by New Jersey Monthly magazine each year consistently since 2013.
5 Comments
Your an idiot
You're an idiot. No wonder nobody reads this garbage. There are two generics available for Opana ER. The only difference is they don't have the antiabuse chemicals in them, which apparently makes them safer to abuse according to FDA logic.
Jimmy Rudder
All i hear about is how all these people are overdosing on prescription drugs this is a bunch of shit.they have cut medication for pain down to nothing.they have taken the prescribing of drugs out of the doctors hands and put it in the hands of the state.people that have never experianced any type of pain and dont care about people who are in cronic pain.people are dying from a drug called fentenol being mixed with herion it is killing hundreds a day.why not pull fentenol off the market.as long as theirs drugs their will be drug addicts.people who have no training in being a doctor or a pharmacyst should leave dispensing prescription drugs to men and women who are qualified to do so.not our govenor or any other legislator who have no formal training as a doctor.
Scott
I am on Opana er for years and it works for me. I tried about 6 different medicines and they did not work as well as Opana works, I was even on Morphine and it did not work as well as Opana. The Morphine that I was on for 6 months rotted my teeth to the point that I had to have several extracted.
So now that I am on something that well for me with just a few side effects now the government is going to take it away.
I already have to jump through hoops to get my medicine; I have to go to a pain management doctor so I can get my medicine. I have chronic pain so I will be on pain killers for the rest of my life. At first I only had to go to pain management every other month and the doctor would give me 2 prescriptions one for now and the second one dated for the next month, a year or so ago the government made a rule that I have to go every month even though nothing changes.
Now I am going to find a new pain killer that will work.
I hope that I don't have any side effects to the new medication that I am going to have to try before I find one that will work.
Rosie
I have been on oxycotin 40 mg 2× day. I was just advised that I no longer would be able to have coverage. That I need to find a new long acting medication for chronic pain. I'm so lost ,confused scared of withdrawals from a medication I have been on for 6 years. What should I do?
PHIL
The government Cares more about if drug abusers than it does about honest law abiding patients.iI have become immune to most pain killers then I was placed on Opana.This.controled my pain enough so I can work. NOW I FACE GOING ON DISABILITY.GOOD JOB FAD
THINK AGAIN WHO THE GOVERMENT SHOULD SUPPORT.
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