Why FDA Approval of Zohydro Is Controversial

zohydroWhen the FDA approved Zohydro, it said in a press release that the drug offers another variation of opioid for people who may not respond well to existing opioid medications. For some, especially those desperate to manage debilitating pain, this is reason enough to justify Zohydro’s existence. This is the minority opinion. Addiction specialists, rehabilitation centers, doctors, and other organizations and individuals too numerous to list argue that other medications on the market already are similar enough in makeup and function to warrant Zohydro’s FDA approval, especially given the strong potential it has for abuse, addiction, and overdose.

Zohydro is similar to Oxycontin. Both are controlled-release, which works for patients who need 24/7 pain relief, and both are non-combination painkillers. A non-combination painkiller means that acetaminophen is not mixed in with the drug’s active ingredient, which is an opioid. In the case of Zohydro, it is hydrocone. In Oxycontin, it is oxycodone. Mixing acetaminophen in lowers the amount of opioid in each tablet. More importantly, it discourages abuse of the drug because it is is toxic to the liver in high doses. According to prescription drug abuse researcher Theodore J. Cicero, PhD, “addicts don’t like acetaminophen.” However, people with continuous acute pain need to use non-combination painkillers in order to avoid liver damage.

For a few people, then, the drug might have the potential to alleviate incredible suffering. For many other people, however, the drug will absolutely bring about great suffering in the form of abuse, addiction, and overdose. Even if one is able to reconcile this lopsided equation and still root for Zohydro, which is a perfectly just reconciliation considering the level of pain some people are trying to live with, it does not negate some of the disquieting aspects that surround Zohydro and its FDA approval.

For instance, many in the pharmaceutical industry were surprised that the drug was approved at all since the FDA’s own advisory panel of pain specialists voted 11-2 against it in December of 2012. Then, in a move that raised eyebrows even higher, top FDA officials ignored the panel and approved Zohydro one year later. Their approval was further complicated when, through a Freedom of Information Act request, a series of emails was made public that revealed paid, private meetings had taken place between pain medication manufacturers and FDA officials, and one of those participants was Zohydro’s original manufacturer.

Another fact that makes Zohydro’s critics highly suspicious is that the drug will be manufactured by a company named Alkermes that also manufactures a medication, Vivitrol. This medication is used to treat people addicted to painkillers and alcohol. Additionally, Alkermes also gives financial backing to the American Society of Addiction Medicine, a group that represents experts in the field of substance abuse.

Yet another shocker was the fact that the FDA approved Zohydro without requiring it to have an abuse-deterrent formulation. This means additives such as niacin or naloxene are mixed in for the purpose of creating unwanted side effects for drug abusers who would crush the tablet to snort or inject it. Here’s what they had to say for themselves on that issue: “FDA does not believe it is feasible at this time to require that all new solid oral-dosage opioids have abuse-deterrent properties.”

Lastly, the drug will be released in a crushable version. Drug abusers, by crushing and then snorting or injecting controlled-release non-combination tablets such as Oxycontin, are able to circumvent the delayed release and get the drug’s full effect at one time. Crushable non-combination opioids have been called the equivalent of pharmaceutical heroin. Oxycontin tablets are now non-crushable, a measure that came about because the crushable form resulted in huge numbers of prescription drug abuse and addiction. Zohydro’s manufacturers say they will release a non-crushable version of the medication in three years.

To some, the disquieting aspects surrounding Zohydro call into question the entire FDA approval process. More specifically to Zohydro itself, many addiction and medical experts are certain that the lack of an abuse-deterrent in a crushable, non-combination opioid equates to drug abuse, addiction, overdose, and death.

By Donna Westlund


Washington University Newsroom
NY Times

8 Responses to "Why FDA Approval of Zohydro Is Controversial"

  1. Richard Hancock   March 12, 2014 at 7:12 pm

    The real problem is potential for diversion. Clearly, this is a drug which would be beneficial in cases where liver damage is a serious concern. Prescribers should carefully document the basis for prescribing (long term use for chronic pain, liver issues) to prevent prescribing of this drug for short term use. Of course, the inherent argument is that paracetamol IS toxic to the liver and is probably a poor choice for an admixture simply to prevent diversion/abuse. While there will always be diversion, it is hard to believe that controls cannot be put in place to reduce its incidence. This is where the war on drugs should have been focused. Wasted attempts to curb marijuana use over the years diverted valuable resources to obtain arrests and convictions for hemp use while diversion of the real killer drugs quietly metastasized. Of course, law enforcement was playing a numbers game to get easy arrests of kids to get more grants. This low hanging fruit was gathered at a tremendous cost. Now we reap the consequences since the distribution pipelines for hard drugs seem well established. My heart goes out to chronic pain sufferers who are thrice victimized. It is a difficult balance but abusers have more of a choice as to their unfortunate condition than chronic sufferers who have no option other than pain medication to obtain any quality of life. As an aside, we cannot ignore the fact that insurance companies find it cheaper to hand out pills than treat the causes of pain from injuries through HANDS ON therapy and other modalities at an early point. I don’t want chronic pain sufferers to be sacrificed and denied relief but the sad fact is that early therapy and aggressive treatment could eliminate many conditions which become chronic pain situations.

    In the end, Big Pharma will get what it wants. End of Rant.

  2. Expert Opinion (@ExpertOpinion)   March 11, 2014 at 2:45 pm

    Read Expert Opinion on Drug Safety’s FREE editorial discussing the recent controversial decisions at FDA on Zohydro http://bit.ly/1fQc9Sb
    The paper discusses the recent decisions on hydrocodone medication; highlighting big inconsistencies in decision-making and discussing important implications for public.

  3. Donna Westlund   March 11, 2014 at 11:09 am

    Wow, Dana. You certainly are dealing with a lot. Thank you for your input, and I wish you and your daughter the best.

  4. Dana   March 10, 2014 at 12:40 pm

    Donna, You are so right, their are people that can benefit from ZoHydro, I am one of them. I will NOT take it, even it is a option for me. I am on both sides of the fence here, I also have a Daughter who is addicted to Opiates. I feel this is going to be OxyContin ALL over again, once addicted, they will more then likely move to Heroin use. I don’t feel this drug should be released until the coating can be changed, which takes years!

  5. Red Segje   March 9, 2014 at 8:20 pm

    Zohydro has some actual medical advantages over other opiods because it does not include acetaminophen, which is included in other opiod pain meds. People who actually need the pain relief long term are much less likely to suffer liver damage using Zohydro — that is the reason it was approved. It is actually a valuable medicine for those who suffer chronic, severe pain.

  6. Donna Westlund   March 9, 2014 at 8:03 pm

    You are the perfect person to ask this question to: Why was Zohydro approved as a crushable tablet and without an abuse-resistant formulation? Given what happened with OxyContin, it is almost unconscionable, no?

  7. Donna Westlund   March 9, 2014 at 7:53 pm

    Truth be told I am highly skeptical of both Big Pharma and the FDA. I feel terrible for the people who genuinely need these meds to make life bearable but who are given the runaround from their doctors who don’t want to get on the DEA’s radar. Topic for next article! Any insights?

  8. Ron   March 9, 2014 at 5:59 pm

    The tenor of this article cracks me up!! You are SURPRISED at the FDA’s BEHAVIOR??? They have been doing this for DECADES!!

    As a former pharma rep (and, yes, for OxyContin), I can tell you that when you have pediatricians making decisions about opioids, you have a problem. PERIOD!!

    However, now that the technology is there, I agree that no high dose, delayed release opiate should be approved UNTIL it can be done in an abuse-resistant formulation.

    Lastly, naive people don’t become addicts because painkillers are available! Clearly, there is a trigger that causes future addicts to “activate”; not because there is just another rx drug out there, NO MATTER HOW POTENT!


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