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

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