How Did Approval For Zohydro ER Happen?
In October 2013, the FDA announced that Vicodin (a combination of hydrocodone and acetaminophen) would move to a more restrictive Schedule II drug, meaning no automatic refills and no doctor-call-in prescriptions. This was a big deal as hydrocodone is one of the most prescribed painkillers in the U.S. But because the drug is highly addictive, can be dangerous and can actually be counter-productive for long-term pain use, the announcement made sense.
What was harder to understand was why, on the same day, the FDA then announced its approval of a new opioid drug, Zohydro ER. Formulated to help manage long-term pain, Zohydro will also be a Schedule II drug, but it has some significant drawbacks that were brought up by the advisory committee assembled to discuss the pros and cons of receiving FDA approval.
Zohydro ER is pure hydrocodone with no over-the-counter drug included, which will prevent liver damage, argued the manufacturer, Zogenix. But the advisory committee has other concerns regarding Zohydro:
- The drug comes in capsules, a form more prone to abuse than others;
- It is just as potent and addictive as other opioids;
- There is no abuse-deterrent version.
In the end the advisory committee recommended against FDA approval. Which is why so many people were shocked to hear the announcement that it had, indeed, been approved, stating that “the benefits outweighed the risks.”
But how could this happen? To start, a spokesman informed the media that advisory committees are often called to give advice to the FDA, but they are under no obligation to follow that advice. But more significantly it was brought to the FDA’s notice that since Zohydro ER is no worse than any other opioid, not approving it would require revisiting the approval of all other opioids. And that would be time-consuming and expensive for the FDA.
Andrew Kolodny, a physician who has fought for stronger restrictions on pain-pill prescriptions, attended the December meeting as a member of the public and spoke up during a period reserved for comments. “One has to wonder how many more pain patients have to be harmed, how many more people have to become addicted, how many more lives will have to be lost,” he said, “before the F.D.A. finally begins to exercise its authority and responsibility to prohibit drug companies from marketing opioids as if they have been proven safe and effective for long-term use.”
I am perplexed and outraged. At what point will the FDA focus its attention on safety and follow the advice of the experts it calls on for advice?
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