Healthcare Coalition Decries FDA Approval of Extended-Release Zohydro

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.”