• linkedin
  • Increase Font
  • Sharebar

    FDA defends Zohydro approval in opioid abuse debate


    FDA Commissioner Margaret A. Hamburg, MD, defended the agency’s approval of the powerful opioid Zohydro ER (hydrocodone bitartrate) extended-release capsules, explaining that its highest dose is no more potent than the highest strengths of the opioid OxyContin ER (oxycodone) extended-release and extended-release morphine, in an FDA blog posted April 29.

    Dr. Hamburg explained that with the drug approval, it is unlikely that opioid prescribing will change significantly or use by patients with pain. Zohydro ER is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

    “Addressing the opioid crisis by focusing on a single opioid drug will simply not be effective,” she stated. “Instead we must focus our collective attention and energy on the key drivers of the problem, which include excessive prescribing, illegal activity by a small number of providers, improper disposal of unused medications, and insufficient prescriber and patient education.”

    At the end of February 2014, a coalition of more than 40 groups, representing physicians, addiction experts, and law enforcement officials, expressed concern in a letter to Dr. Hamburg that Zohydro would fuel more opioid addictions and overdoses. The FED UP! Coalition asked for the Zohydro approval to be revoked.


    Julia Talsma, Content Channel Director
    Julia Talsma is lead editor for Drug Topics magazine.


    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • DanKaufman
      As a retail pharmacist I am often caught in a bind whether I should fill a controlled drug rx. Sometimes I don't trust the MD or the patient.Two things are needed- first Zohydro should be taken off the market until it is more abuse proof like Oxycontin is- who needs that much Hydrocodone? Second each state should have a program like California has wherin all controlled RX filled goes into a central bank--BUT there should be a law in all states that this bank is open to any drug store so that the pharmacist can tell if the patient is doctor or pharmacy shopping- if someone gets 100 Norco/month from 7 different MD's and 7 different pharmacies why would any one suspecy anything if he pays cash for all MD visits and RX's- I have been asking for this for years- it won't stop drug abuse but it will slow it down.
    • SteveAriens
      In reading the letter to Dr. Hamburg.. the 40 groups that signed the letter are dominated by groups focused on drug abuse. Using the reported 35 K deaths from drug overdoses.. IMO is a overblown number, because - according to stats - few people commit suicide using drugs.. the death is always ACCIDENTAL.. Even using that published figure it would take abt 3000 YEARS for the number of deaths to equal the estimated current number of chronic pain suffers.. that are being deprived/harmed by this myopic view of opiates usefulness and/or denial that these people are actually in pain. I suspect that most of the people within these organizations have suffered a loss of someone over the abuse of drugs.. but is it necessary - or appropriate - for them to spread suffering to those in chronic pain by trying to deny the availability of some drugs to those suffering from chronic pain?