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FDA chief defends Zohydro approval as US states rebel

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2939 (Published 24 April 2014) Cite this as: BMJ 2014;348:g2939
  1. Michael McCarthy
  1. 1Seattle

Margaret Hamburg, commissioner of the US Food and Drug Administration, has defended her agency’s decision to approve the potent long acting opioid Zohydro ER, arguing that the FDA had to balance the risks of opioid prescription abuse with “the very real medical needs of the estimated 100 million Americans living with severe chronic pain or coping with pain at the end of life, which is also a major public health problem in this country.”

In an address to the National Rx Drug Abuse Summit being held in Atlanta, Georgia, Hamburg said that the drug—an extended release formulation of hydrocodone bitartrate—offered an effective option to patients who required around-the-clock opioid treatment and for whom alternative treatments were …

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