Fearing more overdoses, groups urge FDA to revoke Zohydro

A coalition of doctors, addiction experts, and law enforcement officials are urging FDA to revoke approval of the powerful opioid Zohydro ER (hydrocodone bitartrate) extended-release capsules, which reportedly will contain 10 times more hydrocodone than Vicodin.

Zohydro is approved for the management of severe pain requiring around-the-clock, long-term opioid treatment and for use when alternative treatment options are not adequate.

In a letter to FDA Commissioner Dr. Margaret Hamburg, the coalition of more than 40 groups expressed concern that Zohydro will fuel more opioid addictions and overdoses. Last year, FDA approved Zohydro for chronic pain treatment. It is scheduled to become available in March.

"It's a whopping dose of hydrocodone packed in an easy-to-crush capsule," Andrew Kolodny, MD, president of the advocacy group Physicians for Responsible Opioid Prescribing, told CNN. "It will kill people as soon as it's released."

Both FDA and the drug’s manufacturer, Zogenix, said that the drug can be safely used and that Zohydro’s benefits outweigh its risks. “We do not expect the introduction of Zohydro ER to increase the overall use of opioids,” Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, reportedly said. “In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.”

Zogenix announced Feb. 12 that it has established an external safe-use board, headed by Jeffrey Gudin, MD, director of Pain Management and Palliative Care at Englewood Hospital and Medical Center in New Jersey. The board will provide insight and advice to the company about the impact of Zohydro to the community and, if necessary, offer specific recommendations to minimize the risk of abuse, misuse, and diversion.

However, many others fear the worst with the introduction of Zohydro. They speculate that a patient who lacks tolerance to opioids could overdose from taking just two capsules, which will contain up to 50 mg of hydrocodone.

“In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the letter read. “Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”

According to the Centers for Disease Control and Prevention, opioid deaths have more than quadrupled in a decade, increasing from the 4,030 in 1999 to 16,651 in 2010.

In November, several members of Congress sent a letter to the U.S. Department of Health and Human Services (HHS) questioning FDA’s decision to approve Zohydro. An FDA panel voted overwhelmingly against approving the drug. A group of 29 state attorney generals sent a similar letter to HHS opposing the approval of Zohydro.

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