Zohydro: The FDA-Approved Prescription for Addiction

Thursday, March 6th, 2014

Note: This blog was originally published on 2/26/14 on The Huffington Post’s “Science” vertical.

pillsIn a few weeks, a powerful new opioid painkiller called Zohydro is expected to hit the market. Zohydro’s easily crushed capsules will contain up to 50 milligrams of pure hydrocodone; that’s 10 times more hydrocodone than a regular Vicodin. One capsule will pack enough hydrocodone to kill a child. An adult lacking a tolerance to opioids could overdose from taking just two capsules.

Many folks on the front line of our nation’s opioid-addiction epidemic were shocked that the FDA approved Zohydro despite the strong objection of an FDA advisory committee, which voted 11-to-2 against it. This may be the first time in history that the FDA will allow a drug to be released despite a landslide vote to keep it off the market.

Concerned about FDA approval of Zohydro? You are in good company. This morninga letter signed by more than 40 organizations was sent to FDA Commissioner Hamburg, urging her to keep Zohydro off the market. The organizations include some of the most prominent addiction-treatment agencies in the country, including Hazelden, Caron, and Phoenix House. Other co-signers include CASAColumbia, the American Society of Addiction Medicine, Blue Cross Blue Shield, the consumer advocacy group Public Citizen, and dozens of community-based addiction-prevention organizations.

Understandably, concerns about Zohydro have focused on the fact that, like the original version of OxyContin, it can be easily crushed — a feature that makes it especially lethal. But there are other good reasons to be concerned about Zohydro. It isn’t just bad for so-called “abusers” who crush the capsules; Zohydro’s risks will also outweigh benefits when swallowed whole by the chronic-pain patients Zohydro’s maker is targeting.

Opioids are excellent medications for easing suffering at the end of life. They are also effective when prescribed short-term to treat severe acute pain. But they don’t work well when taken on a daily basis for months and years. Over time, many people develop tolerance to the analgesic effects, leading them to require higher and higher doses. As the doses go up, quality of life and ability to function often declines. They can even make pain worse, as seen in a phenomenon called hyperalgesia.

At the FDA advisory meeting, several members of the committee raised concerns about the company’s plan to market Zohydro for chronic pain. Before the final vote, Dr. Jevtovic-Todorovic, a member of the advisory panel, stated:

I’m an anesthesiologist, and I’ve been practicing in this field for quite a long time. When you talk to pain specialists in our field, they will all tell you one indisputable fact: Opiates are lousy drugs to treat chronic pain.

Dr. Jevtovic-Todorovic is absolutely right. Over the past few years, many pain specialists have been speaking out against use of long-term opioids for common problems like lower-back pain, fibromyalgia, and chronic headache.

There is another very obvious reason — also pointed out by the advisory committee — that it is a bad idea to take high doses of opioids on a long-term basis. Opioids, which include heroin, are highly addictive. Even if Zohydro’s maker agreed to make the capsules more difficult to crush, we would still need to worry about addiction. After all, swallowing painkillers whole doesn’t make them less addictive. I’ve been treating opioid addiction for more than a decade, and I’ve never once treated a patient whose painkiller addiction began with snorting or injecting opioids. Their addiction always began with swallowing whole pills. Some eventually switched to snorting or injecting after they became addicted, but most of my patients were still swallowing pills when they finally sought treatment. Making a pill abuse-deterrent doesn’t make it less addictive.

According to the CDC, the overprescribing of opioids — especially for chronic non-cancer pain — was the main cause of our nation’s opioid-addiction epidemic. When faced with this public-health crisis, the very last thing we need are new opioids released on the market with campaigns to encourage more prescribing.

If you are feeling frustrated by the FDA’s decision to approve Zohydro, a drug that will surely worsen an already severe opioid-addiction epidemic, I have a couple of suggestions.

First, please call your United States senator’s office and let the staff member on the phone know how you feel about the release of Zohydro. You should also ask him or her for a Senate investigation of the FDA’s decision to approve the drug.

Second, please make your way to Washington, D.C., for the FED UP! rally on Sept. 28, 2014, where you will be joined by thousands of people who are equally fed up by the FDA’s long track record of putting opioid manufacturers’ interests ahead of public health.

I’m not optimistic about our chances of keeping Zohydro off the market. But with a Senate investigation and a large turnout at the September FED UP! rally, we may be able to keep the next Zohydro-like opioid off the market. And we can finally hold FDA leadership accountable for more than a decade of disastrous opioid policies.

By Andrew Kolodny, M.D.
Chief Medical Officer
Phoenix House

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6 Comments

  • Lynn Oliveira

    I am from Fall River , Mass. I am currently trying to get my daughter , Jennifer Moniz into long term treatment for addiction . She Is currently clean, but looking for intense counciling and help getting her life on track. She was incarcerated for the last 5 months. I am appalled at what I see happening to my families children and my friends children where opiate addiction is concern. Someone or many should be held responsible for this epidemic. Doctors , FDA or whoever approves these drugs. I heard this story from a police officer talking about another fellow officer. This fellow officer had back surgery and was prescribed pain killers and became addicted , when the doctor stopped prescribing them, he turned to heroin, he is now deceased. My daughter is a heroin addict and was clean for 5 years , she had foot surgery and then a second foot surgery and was prescribed pain killers that led her back to heroin that left me waiting for a phone call telling me she was dead. In one year she lost everything she had exept two bags of clothes and was back in jail for 5 months , she is now clean but wants some long term help. I will be a voice . I am against what is going on with opiates and I’m willing to be a part of coming against drugs. I own a business and will help anyway I can. Thank you , Lynn Oliveira


  • kschmier

    Hi Lynn,
    Thank you so much for taking that brave first step and reaching out. We are here to help your daughter find recovery–we will have our New England staff contact you shortly. Alternatively you can visit https://www.phoenixhouse.org and call the number on your screen to speak with someone immediately. We look forward to helping you!


  • Alexis

    Just one more reason to at least give the medical marijuana movement a chance. I have sciatica and daily pain from it and choose natural remedies over pharmaceuticals. How many of our population must die before people open their eyes?


  • Kris Mac

    Im not against it what so ever. Everyone can say oh leave people in pain and dont come out with a better remedy bcuz people will abuse it. Thats the same as dont make phone bcuz people will text and drive, dont make alcohol bcuz people will drink it and drive, dont make cars bcuz people will speed and cause accidents. You can stop EVERYTHING bcuz people are going to abuse it. People are going to abuse anything they can. This is 1 drug, they have so many more they can get their hands on and abuse. The pill epidemic wont come to a hault because this 1 drug isn’t released.


  • Roxie

    Some people are just more susceptible to addiction. I’ve been on oxycodone for over a year and have no problem with tapering off what I take on a daily basis especially if I know I need to drive somewhere in a couple days. I’m picking up zohydro in a couple days and very excited about it since u can’t tolerate morphine and I’m having disc replacement in a couple weeks. I won’t even need it the following month as doc says I’ll be out of pain 2 weeks post op-looking forward to sobriety


  • diann hanna

    I just learned about this new drug. I myself am concerned for people with pain. Some people have pain every day. If a drug like this can help, why not. People who are addicted will find a way, they always do. They make things hard for folks that really need medication. For those who do have chronic pain, I say, let them have relief with a doctor monitoring them. It is going to continue to be a battle, with the drug seeking people vs the real patients that need relief. I would hope that good doctors will know the difference. Also, I do believe that a drug like this would be for people with cancer or other really hard to manage pain disorders. It becomes a problem when young people and people who really don’t need it are the ones taking a drug like this.



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