Let’s start with the facts.
Created by drug company Zogenix, Zohydro is the first Hydrocodone-based narcotic to come to market that does not include Acetaminophen. Since many pain patients suffer from Liver Disease and other liver problems, Hydrocodone-based drugs that contain Acetaminophen (like Vicodin) have never been an option for these patients due to the damage that Acetaminophen can cause to the liver. Zogenix claims this was the primary reason behind the creation of Zohydro, and the millions of pain patients that fall into that category will now have another option for treatment. The FDA then overrode the recommendation of an advisory committee who voted overwhelmingly against it’s release, and approved Zohydro in October of 2013 as a Series II narcotic. That’s when the controversy began.
After the FDA’s approval, critics zeroed in on the manufacturer’s plan to offer the drug in a sizeable 50mg dosing option. This dosing size may seem high, but when Zohydro is used properly, the 50mg is set in a 12 hour, time-release formula. High-dose narcotics are also nothing new. Oxycontin, which is several times more potent than Hydrocodone, is already available in doses ranging from 10mg to a whopping 160mg. However, the increased danger of Zohydro may lie in the fact that the drug can be easily crushed and injected by those looking to use the drug illegally. Once the pill is crushed, the time-release formula is broken down, making it possible to absorb the entire dose at once. Drugs like Oxycontin have been formulated to make it difficult to absorb the full dose after the pill has been crushed.
It is for this reason that many vocal critics of the drug have not stopped in their efforts to get the FDA to reverse its decision to approval of Zohydro. In addition to numerous petitions, 28 states’ Attorney Generals have also formally requested that the FDA rescind their decision on the new drug. They have cited major heroin and opioid abuse epidemics within their states, and concluded that access to yet another high-dose opioid will only cause more deaths due to overdose.
The Zohydro debate begs the question; Is it the manufacturers’ and the FDA’s responsibility to make drugs safer for individuals using drugs illegally?
In today’s climate of increased prescription drug abuse, it may be irresponsible for any narcotic manufacturer not to consider the possible effects any new drug may have on the portion of the public that is vulnerable to addiction. However, is the addition of Zohydro really going to make a big impact in the overall landscape of opioid addiction and abuse? These questions are for the most part, still unanswered, and the future of Zohydro is still uncertain. As of this writing, the FDA is standing by it’s original decision to approve its release.