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FDA Commissioner Defends Zohydro Despite Abuse Potential — Physician’s First Watch

Medical News |
March 17, 2014

FDA Commissioner Defends Zohydro Despite Abuse Potential

By Joe Elia

The FDA commissioner is defending the agency's decision to keep Zohydro ER — an extended-release formulation of hydrocodone — on the market despite warnings from state governors and members of Congress that its potential for abuse outweighs it benefits.

Dr. Margaret Hamburg testified before the Senate last week that the drugs occupies "an important and unique niche," according to an Associated Press report. The drug, unlike other hydrocodone formulations, contains no acetaminophen, which has been associated with liver damage at high doses.

Legislation has been introduced in both houses of Congress to withdraw the drug until it's available in a tamper-proof form. However, Hamburg has said that the "technology is poor" for creating such a formulation.

Reader Comments (2)

Don Gentry, DDS Other Healthcare Professional, Ret.

I also agree with Dr. Hamburg' statement and with Barry Smith.

BARRY SMITH Other, Uni

I would add to Dr. Hamburg's point that the current trend toward being overly concerned about opioids adversely impacts pain patients. Very few patients become addicted to any opioid, yet medicine and politics are moving toward such heavy restrictions that many patients will be in severe pain, simply because physicians will be afraid (or unable) to prescribe opioids. Please work to reverse this trend.

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