Article

Healthcare Coalition Decries FDA Approval of Extended-Release Zohydro

Author(s):

A 40-member coalition partly comprised of physician experts on opioid addiction treatment and overdose prevention is asking the US Food and Drug Administration to rescind its approval of extended-release Zohydro (hydrocodone bitratrate), given the drug's perceived dangers to the public.

A 40-member coalition partly comprised of physician experts on opioid addiction treatment and overdose prevention is asking the US Food and Drug Administration (FDA) to rescind its approval of extended-release Zohydro (hydrocodone bitratrate), given the drug’s perceived dangers to the public.

The FDA’s own advisory panel voted 11-2 against the approval of Zohydro; nevertheless, the agency did not follow the panel’s recommendation and approved the medication in October 2013. The opioid is set to hit the US healthcare market this month.

Calling Zohydro a “dangerous, high-dose opioid,” the Coalition to End the Opioid Epidemic noted US deaths and addiction from opioid analgesics have skyrocketed since 1999, especially among middle-aged patients who are prescribed opioids for their chronic pain. In fact, opioid overdose deaths have increased by 415% among women and 265% among men, the organization said.

The letter addressed to FDA Commissioner Margaret Hamburg, MD, argues the highest dosage form of Zohydro will contain 5-10 times more hydrocodone than Vicodin or Lortab, and patients who are not accustomed to opioids could experience a fatal overdose from just 2 capsules.

“Too many people have already become addicted to similar opioid medications and too many lives have been lost,” the coalition wrote. “There is no need for another high-dose, single-entity opioid.”

Related Videos
Jonathan Meyer, MD: Cognitive Gains, Dopamine-Free Schizophrenia Treatment with Xanomeline Trospium Chloride
Chelsie Monroe: Challenges Clinicians Should Consider When Prescribing Muscarinic Modulators for Schizophrenia
Thumbnail for schizophrenia special report around approval of Cobenfy.
Thumbnail for schizophrenia special report around approval of Cobenfy.
Thumbnail for schizophrenia special report around approval of Cobenfy.
Thumbnail for schizophrenia special report around approval of Cobenfy.
Thumbnail for schizophrenia special report around approval of Cobenfy.
Developing Risk Assessment Tools for Viruses in School
© 2024 MJH Life Sciences

All rights reserved.