FDA Chief Defends Hydrocodone Painkiller Approval

Law360, New York (March 13, 2014, 5:42 PM EDT) -- The U.S. Food and Drug Administration adequately determined that the controversial new painkiller Zohydro ER offered benefits that outweigh its risks of abuse — a rampant problem with such prescription hydrocodone drugs — particularly for patients who cannot tolerate existing hydrocodone medications, FDA Commissioner Margaret Hamburg said Thursday.

The FDA has drawn sharp criticism from lawmakers and several states since approving the narcotic painkiller last year, but Hamburg told a Senate panel Thursday that it was necessary for patients who could not tolerate other painkillers which,...
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