Announcement: FDA Approves a Long-Acting Hydrocodone Formulation

FDA approves a long-acting hydrocodone formulation

The Food and Drug Administration (FDA) yesterday approved Zohydro ER (long-acting hydrocodone bitartrate extended-release capsules) for management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

Zohydro ER, a Schedule II controlled substance, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain, according to the FDA.

What does this mean for doctors and patients? Doctors have another tool to manage pain but should use this medication with extreme caution given the risks of addiction and overdose. Patients should carefully weigh the risks and benefits of Zohydro, as they should with all prescription painkillers. If you or someone you know has a problem with Zohydro or other painkillers, please contact us for a consultation – we are here to help.

Live Mentally Healthy,
Dr. Jennie Byrne

Author
Cognitive Psychiatry of Chapel Hill

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