New Pain Pill’s Approval: ‘Genuinely Frightening’

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(Courtesy: Courtesy Zogenix)

(Courtesy: Courtesy Zogenix)

(Courtesy: Courtesy Zogenix)

(CNN) — A potent little painkiller is causing a big stir.

A coalition of more than 40 health care, consumer and addiction treatment groups is urging the Food and Drug Administration to revoke approval of the prescription drug Zohydro.

The hydrocodone-based drug is the latest in a long line of painkillers called opioid analgesics. The FDA approved the medication last fall to treat chronic pain, and it is set to become available to patients in March.

“In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.

“Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”

One addiction expert who signed the letter was more forthright.

“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It will kill people as soon as it’s released.”

The letter is the latest in a series of entreaties to the FDA related to Zohydro.

READ MORE: Heroin Hits Home series looks at the epidemic’s hold on NE Ohio

In December, 29 state attorneys general sent a similar letter to the FDA. The month before, members of Congress asked the agency to review its decision to approve the drug.

The concerns echoed by all groups are broadly about the drug’s potency and abuse potential. They say they fear that Zohydro, especially at higher doses, will amplify already-rising overdose numbers.

“This could be the next OxyContin,” says a petition on asking the FDA to reconsider.

According to the Centers for Disease Control and Prevention, prescription opioid deaths more than quadrupled since 1999 — there were 4,030 deaths involving the drugs in 1999, compared with 16,651 in 2010.

“You’re talking about a drug that’s somewhere in the neighborhood of five times more potent than what we’re dealing with now,” said Dr. Stephen Anderson, a Washington emergency room physician who is not part of the most recent petition to the FDA about the drug. “I’m five times more concerned, solely based on potency.”

Both Zohydro’s maker, Zogenix, and the FDA assert the drug’s benefits outweigh its risks.

“We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids,” said Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, in an e-mail. “In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.”

Galer said the company will focus its commercial efforts on a small group of doctors with good experience prescribing opioids, so that only appropriate chronic pain patients would receive the drug.

Advocates for pain patients say that concerns about abuse, while valid for some, are not necessarily an issue for those patients.

“We know that a person with pain is not a person who abuses medications,” said Paul Gileno, founder and president of the U.S. Pain Foundation, a group that receives some funding in unrestricted grants from the pharmaceutical industry. “A person with pain is a person suffering to get pain relief in order to live a fulfilling life.”

In their petition to the FDA for approval, Zogenix representatives cited examples of patients who might benefit from Zohydro: a 46-year-old male with chronic back and leg pain who had two failed back surgeries; a 52-year-old female with metastatic breast cancer experiencing diffuse pain; a 32-year-old woman with multiple orthopedic fractures.

If Zohydro follows in the footsteps of its opioid-containing predecessors, such a narrow, focused patient group may expand — to patients with low back pain, fibromyalgia, arthritis or countless other chronic conditions.

“The problem is, it costs a lot of money bringing a drug through clinical trials and then bringing it to market,” said Anderson, past president of the Washington chapter of the American College of Emergency Physicians. “You have to anticipate (the drug company) being able to market and get its money back.

“I see this as a marketing ploy where eventually it’s ‘I’ve got bigger, I’ve got stronger, why don’t you prescribe this,’ and I’m terrified of that.”

Bigger, stronger opioids — especially those containing hydrocodone — are a concern. Hydrocodone (Zohydro’s sole ingredient) is one of the most frequently prescribed — and abused — opioids.

For that reason, in October, the FDA said it intended to shift hydrocodone-containing drugs from Schedule III to Schedule II. That rescheduling (still pending approval by the Drug Enforcement Administration) would mean much stricter dispensing and prescribing rules for hydrocodone-containing products.

At the time of that recommendation, the FDA posted a statement on its website that it “… has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”

A day after announcing the proposed drug schedule change for hydrocodone, the FDA announced Zohydro’s approval. It was a confusing juxtaposition, some say.

“Shocking, outrageous and genuinely frightening,” said Kolodny of the Physicians for Responsible Opioid Prescribing.

FDA spokeswoman Morgan Liscinsky said that Zohydro’s approval was separate and distinct from the agency’s recommendation about rescheduling hydrocodone-containing products.

“I find great difficulty (with) the wisdom of the FDA’s approval in terms of protecting the public’s health,” said Dr. Alex Cahana, professor of pain medicine at the University of Washington in Seattle, who was not among those who signed the letter to the FDA. “Risk-benefit thinking suggests that not everything we can do, we should do.”

Zohydro will enter the market already classified as a Schedule II — one reason both the FDA and the drug’s maker are confident it will not contribute to the broader overdose problem.

Zohydro’s labeling will feature warnings about abuse, addiction and misuse, and Galer said Zogenix is working on an abuse-deterrent version of Zohydro that should become available in three years.

None of those precautions has assuaged concerns. Anderson said that while a small subset of patients may benefit from Zohydro, unleashing such a potent drug in the current environment is unsafe.

“Put more of this kind of drug out on the street and, I’ll see more overdoses related to this, no question,” Anderson said.


    • tina

      You obviously have no life your always on here making stupid comments. You have just been reported to fox 8 so when you can’t make comments anymore maybe you will get a life. But I dought it .

  • D.

    Quit punishing people with serious pain just because dumb a s s dopers are mis-using painkillers. Go after the doctors that are prescribing the non-essential prescriptions. If a person is in tremendous pain, there is no reason they can’t take something to give them relief. I am sick and tired of a few ruining it for everyone.

    • Lisa Crosky

      I have bad fibromyalgia pain I have been on Vicoden for years Then last month got switched to Norco I was So sick headachy lifeless upper belly pain so bad i went to the ER Very miserable So my dr.wrote me a script for these new vicodens I couldn’t afford them 220 dollars however a Generic version is available and my insurance covered them I feel like a new person my depression and energy levels lifted overnight I feel they are very effective no belly pain no more than 3 a day needed they are an antidepressant-painkiller Perfect for me !

      • Elena Sifuentes

        I am glad you found some relief in a generic, I could use something like that, I have Fibro, degenerative disc with arthritis, arthritis in all my limbs, white spots up and down my spine yet to be diagnosed or biopsied, very painful, and I have two holes in my skull that have gotten progressively bigger since last year also not been biopsied nobody in Phoenix does biopsy of the skull because a saw is needed. The pain in my head is horrible it makes me nauseous. So I could use something like that. I was on Vicodin for a while and had to change doctors and they are sending people to Pain Clinics now to get anything I can’t see them till March and I feel like I am dying.

  • K

    As a person with chronic pain, I have taken percocet, oxycotin, and vicodin. Not at the same time mind you but at separate intervals to see what pill will help me through the pain. I can tell you that percocet and oxycotin are a lot stronger than vicodin. I hated the way the percocet and oxy made me feel. While the vicodin that I take now does not take away the pain like oxy and percocet did, it does allow me to function. When I was taking the percocet or the oxy all I did was sleep. Even my doctor said that vicodin is not as strong as the percocet or the oxy. People who are in real need of these meds are being penalized by the abusers. Stop putting those who are in need in the same group as the abusers.

    • Josette Barry

      Its very important to understand what risks are being taken to get out of pain though. When you look at the potential life-ending risks for a pill 5 times more powerful than the pills you have said worked to alleviate your pain, does that not scare you? Pain-pill abusers aside, are you really going to feel safer and better knowing the potential death you could face in your future from trying to rid the pain so you can function? There is so much more to this and unfortunately, the pain-pill addicts out there are a HUGE deal when it comes to the release and availability of these drugs to those who do genuinely need them. I understand that pain can also be psychologically caused. People, such as yourself, who have genuine Fibromyalgia, Cancers, and infections are going to be harder to distinguish because of how hot this pill is going to be in the drug trade market. People need to have a way to get out of pain because life isn’t worth living if it has to be lived in pain, but this pill is honestly TOO powerful and the FDA has admitted it. The FDA is willing to risk your life for you to be out of pain and to make money from it. Are you willing to do the same?

      On a final note, if they were to simply remake the pill, make it 2 times or 3 times as powerful, hell make a pill for each 2x, 3x, 4x, and 5x and sell them as needed for the level of pain, that may be a whole lot safer. Before popping a 5x, see how a 2x or 3x does, especially if the doubled or tripled amount is in comparison to the oxy or percocet that works for you. Good luck and God Bless you and people in your position.

    • Carla Miller

      I agree I have taken all of them also due to chronic back pain and have been using oxycodone (vicodin) for over 3 years so I can continue to work. I haven’t went to other drugs, I need these meds to help live some kind of normal life. At the end of the day after work I am still in a lot of pain but that has never made me think I will take more pills than the doctor says.

    • K

      Hydrocodone is vicodin, oxycodone is in percocet and of course oxycotin. I am looking at my bottle right now and it says hydrocodone bitrate and acetaminophen.

    • KB McFArland

      Vicodin is Hydrocodone and Percocet is Oxycodone. I have been on both and they work the same for me. I have degerative joint diseas and have had 4 knee surgeries, so I have chronic pain. I have been using hydrocodone for the past 20 + years and have never had an addition problem. I am tired of medication that works for people who truly need it being over regulated or outright removed from the market because of a physician over prescribing it, people not using it correctly and the illegal activity with it. I think these are regulated enough, but hydrocodone at 5X the normal strength is just going to cause problems for those who truly need pain medication. Just let physicians prescribe more of the lower dose tablets or make a tablet that is only 2x the normal strength. I have never understood how a person can become addicted to anything in such a short period of time.

  • Josette Barry

    I would very much like to have an idea of how many people/animals had to lose their lives to find out how potent and dangerous this product was…and then to spit on the lives of those people as acceptable losses in order to release a new money-making product for all the pain-pill addicts out there? This shouldn’t be freely available the way they are going to make it. For those who are looking for assisted suicide, GO FOR IT, but geesus, make the pill dosage as small as possible. If the pill as a whole is 5 times more potent, remix the ingrediants to make it, I dunno 2 times as potent as OxyCotin or Hydrocodine.

  • Allison

    as a person who has chronic pain due to pancreatits, i welcome any new drug that may take my pain away. i am alergic to vicodin, the only option for me is either sit in a hospital w/ IV fluids, no food, no drinks, and morphine, or take percocet. this is only going to last so long before i become immune to it. I have tried other methods for relief such as meditation, yoga, other meds, patches, etc. NOTHING works. for us people who are in chronic pain due to whatever illness we may have, this whole “lets make it harder so drug abusers cant have access to these ‘terrible’ drugs” campaign is making it worse on us who NEED them and DONT abuse them.

  • c u next tuesday!

    @sue get a life y dont you?you clearly dont have one because all you do is sit around arguing and acting like you run fox 8 and can say who and who can not post.Sounds like ur a sad irrelevant ugly old grandma who no one cares about listening to anymore so u bother people on the internet,Maybe if you could act like a decent person real people may want to talk to you….but i wouldnt hold your breath or do dont care you are just a loser.

  • Tim

    Has anyone talked about the fact that 97% of all opiates come from Afghanistan and that our troops our protecting those poppy fields? Seems to me we could stop this epidemic dead in it’s tracks by not allowing the Pharmaceutical Companies to make billions of dollars off the opiate trade deals. Why would we be protecting those fields? The Afghanistan’s fund terrorism with that money crop and along with our Federal Government /Big Pharm companies, sit back and watch as our nation becomes addicted, our loved ones die, our families suffer and the threat of terrorist attacks are well funded! If I were the POTUS, I would be blowing up those fields every week!! There are alternative pain medications that have nothing to do with opiates! I guess there just isn’t any money in a true cure for the problem!! Shame on pharmaceutical companies, the federal government and the pill mill doctors that prescribe death for the American People!! Signed……….Father of a heroin dependant Son!

    • Michele

      Tim, you are the only sensible one on here posting a comment. This new drug is downright sickening. I am very afraid for all who will be prescribed this dangerous opiate. I would like to know who the brains are behind this idea that we need to make stronger opiates to kill pain. I am going to get slammed for this last comment, but I can guarantee you that all who have posted on here stating they take any sort of opiate long-term are addicted. That is just the beast of an opiate, so please those of you who are taking opiates chronically, do not judge and say that the “junkies” are going to ruin it for you. It is your doctor who prescribed that opiate to you the very first day instead of trying an alternate medicine/treatment regimen who is to blame. OxyContin was first put on the market to treat ONLY cancer patients and the terminally ill, but then doctors who had no idea how to treat their patient’s minor aches and pains said, “Hey, I have a fix all pill, it’ll cover everything from a sinus infection, sore throat to your back pain or your terminal illness.” Now we have a society addicted to opiates and dying every single minute. I am a mother who knows this first hand.

  • Pamela Lennon

    As a person who suffers from chronic pain and have been through the unbelievable process of trying several different means of helping me get some sort of relief…I am so so sick and tired of those of us being punished and have to suffer because of the idiots out there that look to get and use the drug inappropriately, thus keeping it from being given to those of us who truly need the relief. I have been told out right that my DR doesn’t want to prescribe this or that because of the chance of becoming addicted to the drug…I KNOW who I am and what I feel and how I WISH I could feel, I have tried Vicodin, Percocet, Tramadol, Hydrocodone, to mention a few…and have not found any true relief from any of them. Dr.s should know their patients and review their history in depth, and KNOW if we are the drug seekers looking to get high or make money off the drug.

  • Leah

    There is going to be addiction problems no matter what is put out or what is taken off the market. People with legit pain get the pain meds and sell them to people with addiction. Sometimes people with chronic pain really need relief and become addicted. These pain killers are toxic! Some people can take them as directed and be fine. Some people take them and become immune to them and need more and more and eventually become addicts and turn to something stronger. If there is a will there is a way. People will find the drugs. Its a secret black market of pill buying and selling.

  • Kim

    This is just another medication in a plethora of opioids available to be prescribed for pain. ALL of them are like this!! To target this one is ludicrous. People will always find things to abuse and misuse…glue, aerosol, even peach pits. Oh, and let’s not forget the ‘candy dish’ parties that kids/adults throw. I would be way more worried if it was over-the-counter. However, Tylenol is one of the most dangerous drugs out there and it IS over-the-counter! Not necessarily addictive, but using more than the recommended dosage or overdosing and a person will be in liver failure in the blink of an eye! At some point we need to stop making everyone else responsible for our own actions.

  • AnTikram Thira

    :'( sad seeing all the negative… My Dr. took me off my medication w/o completely monitoring me, never have I failed a drop test, never have I crossed and lines of wrong doings… His complaint: Late picking up my meds :'(

    I’m suffering everyday life. Are you SUE going to say anything negative at me? I’m a 35 year old woman 100% disabled, I CONTEST TO DOING NOTHING TO DESERVE THIS!!!

  • Miguel Holmes

    I have broke my leg in two places, had four knee surgeries, and have arthritis. Because though, I’m allergic to NSAIDs. Every now-n-again, I, need to take vicodin or percocet. Yet, because of a small minority of the population that if you, would give a sugar bill too, they would abuse it. Getting painkillers from Dr. is like trying pull teeth from an awake tiger. Hell, my Dr. even told me, you, have to live with pain. I’m looking for a new Dr. btw. But, still. There is no need to be in pain. Yet?

  • Ken Wilson

    There is no place for racism in this world. Keep your racist views to yourself and pray to God to take them away from you! I am a white American and some of my best friends are black. Blacks aren’t the backstabbers that whites are. Good and bad in all!!

  • zachary

    Instead of them creating new pain killers to help people with chronic pain, maybe they think about legalizing medical marijuana. You cannot physically get addicted to marijuana and it would also create jobs but no don’t listen to people like me, I guess a lot of people would rather see people get addicted to a man made drug than to legalize a drug that is simply grown just like the tomatoes in your backyard.

  • Linda Myers

    I cannot even imagine why any one would think that a drug of this magnitude is needed on our streets, I do understand people who has pain, NO ONE is pain free,, there is alot of things in LIFE that we as people just have to learn to cope with. This drug will destroy more lives than it could ever possibly help.. PLEASE dont you see this, . we already have a epidemic when it comes to Heroin and pain pills, and you think Doctors monitor who they give it to, well NOT ALL OF THEM do!!!! just more money in somebody’s pocket,,, including the funeral directors…Is there nothing as the people of the UNITED STATES OF AMERICA that we can do about allowing this drug on our streets..WAKE UP FDA!!

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