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The Food and Drug Administration’s (FDA) decision to approve Zohydro ER (extended release), a pure form of the painkiller hydrocodone, has stirred opposition from many addiction medicine experts, public health officials and legislators. Join Together spoke with Dr. Richard Blondell, Vice Chair for Addiction Medicine in the State University of New York at Buffalo Department of Family Medicine, about the issue.
Why is there such controversy about Zohydro’s approval?
Dr. Blondell: It’s a question of risk versus benefits. Zohydro, unlike combination hydrocodone products such as Vicodin, does not contain acetaminophen. The FDA says since acetaminophen has safety risks—including potentially deadly liver damage when taken at a high level—Zohydro can be a good option for patients who need high doses of the medication, without the associated liver toxicity risk. They also say it gives doctors another option for prescribing opiates, so they can rotate medications.
However, the risks are great. There is no mechanism in the Zohydro pill for tamper resistance. If people want to abuse it, they can extract high doses of hydrocodone and inject it. The risk is it will create more addiction in people who are prone to misuse and addiction.
What about the argument that more, better opiate medications are needed to treat patients in pain?
Dr. Blondell: There are already a lot of opiate medicines available—there is not a critical need for another one. Zohydro is only a slight variation from many other opiates that are already on the market, and the benefits are minimal. Zohydro is not a big new discovery that will be a watershed moment in medicine.
Why do you think Zohydro poses such an addiction danger?
Dr. Blondell: We already have experience with opioids extracted from pills causing death. Before OxyContin became tamper-resistant, people died after injecting it. Since Zohydro is not tamper-resistant, people who want to abuse it can extract a pretty stiff dose and inject it, which can be fatal for people with a low tolerance.
What needs to be done to reduce the risk of addiction to Zohydro and other opiate painkillers?
Dr. Blondell: We need to better educate our physicians about how to use these medications, how to assess patient risk for abuse, how to screen patients for the development of addiction, and how to intervene early to get patients into treatment before they ruin their lives. This is what we should be doing instead of spending all our efforts developing another opiate, when the market is already flooded with opiate products. We should instead be educating our physicians to use the products already out there.
What do you want the FDA to consider as Zohydro comes to market?
Dr. Blondell: I’m sure the cost of developing a tamper-resistant pill is high, but what is the cost of hundreds of overdose deaths each year? The success in the marketplace has to be balanced against the negative effects to human life. If we see overdose deaths from Zohydro, will the people who approved it take ownership for being part of the problem? As an addiction medicine specialist I’ve seen misery and suffering. I’ve talked to parents of children who have overdosed. I see the human cost of addiction on a daily basis. I think that it’s too big of a price to pay.
Richard D. Blondell, MD, is a Professor and Vice Chair for Addiction Medicine in the State University of New York at Buffalo (University at Buffalo) Department of Family Medicine, and is the Director of Research on Addictions for the University at Buffalo Primary Care Research Institute. Dr. Blondell is a founding member of the American Board of Addiction Medicine and the ABAM Foundation, serving on their Boards of Directors since 2008.