FDA Asks Endo Pharma to Take Opana ER Off the Market
http://www.medscape.com/viewarticle/881337
UPDATE: Number for FDA is 1-888-463-6332 option 3, then 2, then 4 to get pharmacist about Opana ER. If it goes and it will take the generic too.
The US Food and Drug Administration (FDA) has asked Endo Pharmaceuticals to remove its abuse-deterrent extended-release formulation of oxymorphone (Opana ER) 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,” the FDA said in a statement.
This marks the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale because of the public health consequences of abuse.
“We are facing an opioid epidemic — a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The FDA’s decision is based on a review of available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection after the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with an outbreak of HIV infection and hepatitis C, as well as cases of thrombotic microangiopathy.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”
As previously reported by Medscape Medical News, on March 17, an FDA advisory panel of independent experts voted 18 to 8 that the benefits of reformulated Opana ER for relief of severe pain no longer outweigh its risks.
Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.
“While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market,” the agency explains in the statement.
The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the FDA said it will take steps to formally require its removal by withdrawing approval.
The agency will “continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.”
Filed under: General Problems
*Opana ER was an extremely effective medication for those that could not tolerate or respond to *Oxycontin. For those with genetic liver enzyme variances that cause metabolization issues and failure drugs an issue this a double shame on their lose of its use and to science that was not considered by the Food and Drug Administration. There is little doubt that *Opana ER became a drug choice to abuse by the same drug abusers that had also preferred *Oxycotin but may have lost their access to the drug, but the point remains , until our government truely addresses addiction as a social and mental health issue, offers these individuals safe legal medicine they can use for their addiction they will only continue to die, get deadly infections, flood jails and remain untreated addicts useing legitimate useful medications for their self destruction. *Opana ER did not cause the HIV ,hepatitis C ,infection problem.. the Public Health crisis that has yet to be addressed of addiction caused and the decisions made by those individuals that suffer from addiction, the same way they will surely find a new drug to abuse in its place. Lyrica has become a drug choice for many in Europe now causing widespread deaths, but it’s medical uses recognized it would never be taken off the market to those who need it with fibromyalgia or other neuropathic pain issues. Our government needs to stop trying to be a tyrannical babysitter and Nanny to its people and start addressing problems with real science and real solutions based on proven social science methods, and refrain from prejudices of both legitimate pain patients and those with opioid abuse disorders.
Lindsay from,
The Insufferable Movement
This makes me sick. These people are doing nothing but trying to act like they are doing something, instead of going after all the illegal garbage flowing into our country through China and Mexico. Pain patients suicide rates are going to sky rocket, not to mention those that will turn to the street for relief. Sad
Ok , so just because some idiots will do anything to get high, your going to remove a drug that helps patient’s?? Wow. A new low.
Please watch President’s Commission on Combatting Drug Addiction and Crisis commission headed by Christie? It made me sick to my stomach. It’s lengthy, but shows all involved and we’re always saying “follow the money.” I looked up one in a quick google search and found much corruption. When hearing 91 (legal/illicit opioids) vs 121 suicides daily I fell off my chair. I’d say we’ve a suicide epidemic and they just don’t care. We know it’s not legal RX’s causing the “so called” opioid epidemic just as they do. Go to http://www.whitehouse.gov/ondcp to see notes & what was submitted by each group. Here’s the article with video, but don’t say I didn’t warn you?
http://www.alternet.org/drugs/christie-silently-steers-opioid-panel-ditch
Let’s give them an applause for killing more by suicide? More will follow as the FDA removes Opana ER. They deserve a standing applause for genocidal policies in the gold ole USA…. NOT!!!
It shows the entire world that ALL lives don’t matter only 2.1 million abusers.
I’ll lay and wither away when it’s removed so my spouse can SUE THEIR ASSES.
Notifications aren’t needed to remind me that I and many others don’t matter.
Thanks Steve for all your work.
Total bs. So instead of going after the crap coming in our country, lets take a drug away that eases the suffering of millions, who take it as prescribed. One way to get the suicide rate up there, while sending others to the streets for pain relief. Make sense????
To who ever it concerns thank you so much. please feel free to publicly post and use this my story and grief of this horrible malady and the the Hell the now uninformed Public and some of the Media are putting us legitimate Chronic Pain Sufferers through! It is no more than local emotional Abuse ( and border line Domestic Emotional Terrorism )!on a scale with only Biblical proportions!To the Editor and Associates I have taken this opportunity to share my heartbreaking story in hopes these witch hunting Opiate ill informed skeptics will read and understand that we as Millions Of Legitimate Chronic Pain Sufferers would have no life without Medically prescribed Opiates by a physicians care and strictly monitored monthly urine and blood test. Please remember that An Opinion Before A Thorough Investigation Is The Epitome Of Ignorance! And that a little more compassion from the Medical Field and its representatives could have saved my beautiful Stepdaughters life. Let me say this! A person who has a addictive personality will abuse anything that helps them feel better. I have taken Oxycontin for 12 years , I have had 20 major surgery’s in 9 years. I have so much physical pain I can not even get out of bed with out pain meds and when I run out I run out and just lay in bed praying the Lord relieve me of this horrible condition and I pray God you pain med skeptics never go through what I go through everyday of my life when the only thing you have to do is threaten what help I get, Shame on them! There will always be drug abuse and as the so called war on drugs has failed all this will! All you do is stoke and aid the drug pushers business to knew heights in the Black Market of Heroin while trying to deprive folks as me to this horrible movement! My Stepdaughter committed suicide 4 years ago because of being treated like a drug addict by her family and doctors when all along she suffered from Lupus and Fibromyalgia which I believe was brought on by a deadly car crash at 18 , she told me between that which I was being put through and what they were putting her through she was not going to be able to live her life in such a hell brought on by people like the Biased Uniformed Skeptics that are on a witch hunt to out law Opiates and pain meds that give us some sort of a life . As a retired Police officer and worked indirectly close to the DEA, you people do not have a clue how thrilled you are making the illegal opiate trade and think of my Late Stepdaughter as you continue on with this 2017 Version of the ( 1940s Propaganda Film named REEFER MADNESS )movement to outlaw opiates! Just like the slaughter of children at Sandy Hook if there would have just been gun laws , my God they were Gun Laws , the guns that murdered all those 20 children were all registered and owned by a school teacher! You fight Drug Addiction in Elementary education by teaching all children the dangers of Booze and Tobacco which if these witch hunters want for us to know the real truth but they do not. I miss my Stepdaughter so much and some of us will continue on the fight to protect our right to feel better and function without fear of these witch hunters trying to convince us to commit suicide . And they are trying to do exactly THAT and are now being successful in this under the table practice of Human Genocide!
The under line real truth it seems THESE witch hunters would rather us Chronic Pain sufferers commit suicide are and DRINK all the BOOZE we can drink! The Federals legalized it ( ALCOHOL) knowing its a more deadly drug than Strychnine. And just because the DEA has miserably failed with their witch hunt type movement on drugs why do they continuous fully deprive us sick people of our Constitutional Rights to be Happy in that pursuit of with Professional Physicians to take meds that give us relief of this horrible malady of Chronic Pain ! May God have mercy on their miserable souls they that seek to destroy us Chronic Pain Sufferers only and little hope of temporary relief of this horrible sickness. Below picture of me and my Stepdaughter Sissy a year before she committed suicide. Also , as one of my Attachments a Letter I received after pleading with The at the time the President Of The United States Of America was President B, Obama and a letter from Senator Richard Burr with Senator Orin Hatch’s Bill that was made Law to protect Legitimate Chronic Pain Sufferers as myself.
This is not a good sign. I’m so disturbed that addiction is the only concern here. This is an extended release med that people need to live through chronic pain. I know someone fighting cancer who was taken off pain meds for fear of addiction. I have chronic pain and have never become addicted. Never even felt high from my meds in 12 years. They allow me to work and function much better than before. Guess who’s going back on disability if these medications are removed? Decades of studies have concluded that less than 5 percent of chronic pain patients abuse their meds. This is only going to fuel the unspoken crisis in the chronic illness community – Suicide.
We better start calling that phone number above.
pss,,Maybe Sherry,,,contact thee manufacturuer of this medicine,,see if u can get people together,,over thee amount of 17,,,to ,”testify,” how much it has allowed u to live life????I don’t know,,,gotta try,,,,,,maryw
Unbelievable. the harm they are talking about was 17 abusers, shared same needle and got Hep.C. Why is that my fault? This is the only ER that works for me. I don’t snort, inject or use illegally. What are we suppose to use instead? The other ones we have tried and don’t work? What is wrong with government? What medication will be next? Can’t even find who to contact about this but it wouldn’t matter. Sounds like it’s a done deal. Stress makes pain worse and this witch hunt they are doing on pain patients is causing us all more pain. Why won’t anyone listen or help us?
What they are probably referring to is the HIV+ , Hep B&C outbreak in Scott Co IN a couple of years ago.. almost 200 people in a short period.. they were mostly shooting up Opana and 85% of the pts DNA tested that HIV+, Hep B&C were from a common source… problem was that many where sharing needles. Each one of those pts would have a lifetime cost of treating those diseases of $750,000 each… that small country of 25,000 pop… racked up a potential 130,000,000 medial costs on those 200 pts. Scott Co is a very poor county and most likely everyone infected… will be treated on the “taxpayer’s dime “
They go after this medication for that reason so what will be next? I’m sure OxyContin is more popular (and regular folks hear more about that) so are they going to eliminate them all? Don’t they realize that abusers will still get what they need from the black market? What are we suppose to do? It is bad enough that we are being reduced or thrown to the curb.
hmm,,,if health care was paid for by deleting the DEA,, or the 630 billion spent to spy on Americans ,,or the ,”$$$$$,” on black budgets,,,,the rite to health care,,w/out the fear of loosing your life,,,if healthcare was cover’d by the government ,by getting rid of the agency’s above,,or capping,,thee amount for procedure’s,,equipment,,ie,,mri 15 years ago 1400.00,,,,now,,,6 grand,,,,,,those medically ill people would be covered w/no problem financially for ANYONE,,, or cutting retirement for senator etc,,,,,maryw
Why aren’t they taking needles off the market then?? How flippin’ stupid are these people at the DEA who claim to have our best interests at heart and are so concerned about this country??? We all know the answer already, lol. So frustrating and unfair for those who honestly need pain control.
Great job FDA you just killed more people including myself who take it as prescribed without any other options. The key word is ABUSE not taken as prescribed. We all thank you for proving that addicts are worth more than one with a chronic illness and pain. Mary, I agree with you 200% and you have my email. My fighting is over and I give up. There’s nothing more I can say, but thank you for killing us to save ones who don’t want to be saved.
exactly Sherry,,what thee government is doing is NOT NORMAL HUMAN BEHAVIOUR,,,”’ is it?!!!!!!!!it never ever was about us,,,it was always ,”against us,”’ and about money!!!think about it ,,if u can,,whilst u still have your meds,,,think about it,,,with 26,000 MORE DEAD,, how is that ,”saving,or for our welfare,,”…its not,,,,,,they are truly willfully killing us,,They know dam well,,,it is NOT normal for any human to live a life in forced physical pain,,,they know from soldiers who shot themselves or others to stop the suffering the physical pain from torture or injuries,,,THEY KNEW WE WOULD HAVE TO CHOOSE DEATH AFTER TAKING OUR MEDICINE AWAY,,,,,,,THUS,,,,LESS FINACIAL ,”BURDEN,,” IN THEIR MINDS ON THE MEDICAL INSURANCES,, however,,,if they filled up the Pennhursts,,,,,,the old mental health warehouses,,,,insurances will hand out 30,,,to 60,000 at a crack,,,no ????ask,,,,Why do u think they put the 1 survey question out to all doctor w/thee only option to pic,,,,,chronic pain patients are the biggest obstacle to stopping prescribing opiates,,,,
I think this whole genocide was conceived around 2005 ish,,,2009 they literally changed the definition of a controlled substance from specific names of drug to ,”’CHEMICALLY SIMILIAR,,” to be able to put heroin in the wording,,”opiate related,”’
THIS IS THE PROHIBITION OF OUR TIMES,,,THE REGRESSION OF THE SAME PROHIBITION IN THE 1920-30,,,THIS IS THE WITCH HUNT OF OUR TIMES,,,which is why freidmen quoted thee addictions after the civil wars on thee history channels history of drugs,,,THEY CONCIEVED THIS ABOUT 10 YEARS AGO AND PUT THEIR PLAN IN ACTION,,,THEY THOUGHT THIS OUT,,,,,,,,,,for the monies,,,,,,NOT OUR HEALTH AND THE FREEDOM TO LIVE LIFE,,,,,,BUT IF WE DON’T FIGHT BACK,,,,,,,THEY’LL CONTINUE TO WIN,,,,,,THUS KILL US OFF 1 BY 1,,,,and they know it!!!maryw
Yea i agree with you just said finally was on something that working again thank you FDA abuse is the question taken as prescribe no so us what we suffer like to see you in shoes after being hit by a tree while working the woods 8 screes an rods in my back whst make a month now i made in a week until my tragedy in 2001 so thank you again FDA for making my life hell agsin it never fails some work’s they take 58 years old suffering to you
WHICH ONE IS NEXT????? I am afraid to even write name,,,,,???this has got to stop,,,,yesterday!!!!!!!!!!