In a bid to thwart the opioid epidemic, the Food and Drug Administration has asked Endo Pharmaceuticals to withdraw its Opana ER painkiller over concerns that the drug is too easily abused, the first time the agency has made such a move.
“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,” said FDA Commissioner Scott Gottlieb, who vowed to address the nationwide problem of opioid addiction and abuse before he took the top agency job last month.
The decision comes three months after an FDA panel voted to yank the drug, which it approved in 2006, but was not considered to be “abuse deterrent.” The pill became notorious after it was blamed for prompting an HIV outbreak in rural Indiana in 2015, and it was also linked to reports of a rare but serious blood disease characterized by clots that can lead to organ damage.
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Scott gottleib is terrible.
Also I don’t like the idea of FDA threatening companies if they don’t comply with their requests. It is also my understanding that if they had declined to reformulate there never would have been that HIV “outbreak”, thus there would be no cause for removal. I can’t prove it but this has Andrew Kolodny’s fingerprints all over it, I don’t know why ANYONE would listen to him
The end game of the artificial “opioid epidemic” panic—which they harp on every day, trying to conflate all all drugs from Percocet to heroin, pretending they’re all the same: “opioids”—is that eventually pain medication may no longer be available. Doctors are already afraid to prescribe it and pharmacies afraid to dispense it. “Try meditation,” they’ll say. “Drink some tea.” That will do until someone figures out a way to get high off of tea.
It is an epidemic, but one of political crocodile tears for drug addicts who die of overdoses, as drug addicts always have and always will. Making doctors afraid to prescribe even three says of Percocet for an injury will have no effect on heroin deaths, only on patients in pain, and that is intolerable.
It may make managing the “drug war” easier, but it will mean misery for innocent patients in pain. Help heroin addicts, and help discourage the choice of heroin addiction in the first place, but however your drug war is conducted, leave the rest of us out of it.
@tw, public shaming usually doesn’t work. The only instance I recall was when I was working for Abbott when they were selling powdered baby formula to third world countries but were too cheap to sell them the water, so the formula got reconstituted in water contaminated by untreated human waste. That was a bad hair day for dear old Mother Abbott.
This is long overdue– the FDA has known that reformulated Opana ER is a liability for tampering and injecting, which is why they declined to grant the reformulated version new labeling to acknowledge abuse deterrent properties. I believe this was back in 2013. The outbreak of HIV in Indiana was traced to injecting tampered Opana ER. So this action is long overdue.
However, to stop opioid tampering for inhalation or injection, we need to stop just focusing on extended release (ER) opioids. ER represents a small percentage of prescribed opioids. Most of the abuse– tampered or not– is with the short acting opioids. These are almost 100% generics, so there are no abuse deterrent versions of any of these, because without a patent, there is no one motivated to develop one. The vast majority of abuse of Rx opioids is with generic short-acting versions of hydrocodone and oxycodone. You just dissolve or grind them up and inject or snort. No special processing required. Abusers love ER because they contain a higher amount of active ingredient, but these have become quite hard (and expensive) to acquire these days. Statistics show that immediate release/short acting is where most of the abuse of Rx is happening, and where abuse is growing. Abuse deterrent formulations of short acting (that are proven to deter oral, inhaled and injected use) is one way to address abuse, but is not being discussed much.
I know lots of people say, just stop prescribing so many opioids, and this is in fact happening, but there are really no good alternatives for severe pain.
” Just stop prescribing opioids”, that’s easy for them to say if you aren’t a chronic pain patient. I’m glad that you are not, but just wait til you or someone close to you is.
There will always be drug addicts. The focus needs to be on the drug dealers.
There are many alcoholics and people dieing from drunk drivers, but no one is pulling alcohol off the shelves or making it harder to purchase or suing distilleries.
CDC just announced in an article today that there are over 2.2 billion people overweight & obese in the world. USA #1 of 20 well populated countries. 108 million children! 600 million adults!(this was published in New England Journal of Medicine & again at Drugs.com)
Now that’s an epidemic!!! The cost of health care for these obese people, young & old. The amount of adults probably on disability. The overall cost to this country. Overall medical issues from being obese.
I don’t see anyone suing fast-food restaurants, the makers of ill nourished fattening foods, schools that have cut out physical ed classes or sports related teams, etc etc etc
Tobacco! Need I say more??
But keep depriving pain patients their meds so they can’t work or be the care givers they want & need to be for their families, they just want some quality of life!!
Go after the drug dealers! Help the addicts so they arent over dosing. Help keep pain patients from seeking street drugs to relieve pain and then end up overdosing. Or from committing suicide!
Legally this product does not meet the criteria for a Class 1 recall as the product is not inherently dangerous when used properly. The first step would be for FDA to request a voluntary (Class 2) recall, which of course the company will fight. They will duke it out in court for a few years and the company will finally agree to some kind of balony registry, monitoring program or reduced manufacturing all the while the dope chemists are crushing it, cutting it and selling it at a premium.
all valid points. however the big stick here is public shaming. Endo fights, and risks becoming a national public pariah. don’t underestimate the risk of that– Endo better not.
all valid points– there is a lot of money at stake for Endo, and they are already hurting. however they should not underestimate the risk and damage of public shaming. They could easily become a national, notorious villain if they fight. the damage to their brand would be severe if they were called out by the media
When you are a patient with acute back pain from a fall and the primary care physician says he hates narcotics and prescribes Neurontin which is a crappy way to get drunk and sleepy, and when you tell him no. He says take Tylenol. High doses of Tylenol are rough on your liver, but no matter at least you aren’t addicted. A very short course with no refills would provide pain relief and the ability to function while your back heals. Opioids can be prescribed properly and coordinating opioid RXs into a single accesssible data base could keep multiple scripts a rare event. Take it from someone in pain and no addiction problem, we are being punished for a problem we did not create.
Never should have been marketed
Fake news