FDA Panel Rejects Extended-Release Hydrocodone

Karen Lee Richards Health Guide
  • Earlier this month, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee overwhelmingly voted against recommending approval of Zohydro ER, an extended-release version of hydrocodone. If approved, Zohydro ER would have been the first hydrocodone medication available that did not also contain a non-opioid analgesic such as acetaminophen or ibuprofen.


    While the FDA does not have to follow the recommendation of its advisory committee, it usually does. The final determination is expected to be made by March 1, 2013.


    Despite the fact that Zohydro ER was studied in nearly 1,500 patients––some for as long as a year––and found to be generally safe and well-tolerated with no new or unexpected safety problems, panel members expressed concerns with potential abuse, addiction and long-term safety.

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    It was noted that the manufacturer didn't offer any solution as to how they would limit unintended use other than the already tight distribution channels. Another problem for the panel was that Zohydro ER did not contain any tamper deterrent.


    If Zohydro ER, or any other single-entity hydrocodone (without acetaminophen or ibuprofen), is ever approved, it would be considered a Schedule II controlled substance––much more restricted than the current hydrocodone/acetaminophen or ibuprofen combination medications, which are Schedule III.


    My Thoughts...


    I'm extremely disappointed in the panel's decision. Although the FDA is not required to follow their recommendation, the 11-2 vote against approval and the fact that they usually follow their advisory committee's recommendations makes it highly unlikely that Zohydro ER will be approved.


    I feel like both state and federal government officials are falling into what could almost be called mass hysteria when it comes to opioids. They are in such a panic about rising drug abuse that they are enacting extreme laws and placing severe restrictions on even legitimately prescribed opioid medications. They don't seem to realize (or care?) that there are unintended consequences, which can be devastating for chronic pain patients.


    My personal opinion is that this advisory committee was simply caught up in the hysteria. I think they were extremely afraid of approving another drug that might be abused by some even though it would potentially help a lot of people living in chronic pain. The real kicker here is that Zohydro ER would actually be much safer for pain patients who have to take hydrocodone for an extended period of time than the current hydrocodone products because it does not contain acetaminophen, which increases the risk of liver toxicity in long-term users.


    There might be some justification for the rigid restrictions if they truly helped reduce drug abuse, but as I reported to you about six months ago, the abuse-deterrents are not reducing drug addiction. The addicts are merely finding a way around the deterrent or switching their drug of choice––usually to a much more dangerous drug.


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    It's time for the government to take a step back and rethink the problem. Instead of rushing to add more restrictions that do nothing to actually reduce drug abuse but rather add to the pain and suffering of chronic pain patients, maybe they could try to develop ways to help the addicts themselves.


    Unfortunately, it's much easier for politicians to push for tighter restrictions on opioids than to really try to solve the problem. After all, coming out against drug abuse makes them look good to their constituents. Very few people, including the politicians themselves, understand how little those laws do to prevent drug abuse or how much harm they do to chronic pain patients.


    I know I've wandered a bit off the original subject, but I just get so frustrated. It breaks my heart every time I hear from someone who can't find a doctor who is willing to prescribe their medications anymore because of new restrictions and regulations. This latest FDA advisory committee recommendation struck me as one more action that was likely driven more by fear than by whether or not the drug would help patients.




    Pittman D. “FDA Panel Gives Thumbs Down to Opioid.” MedPage Today. December 7, 2012.


Published On: December 27, 2012