The debate over a powerful new painkiller ratcheted up Thursday as the head of the Food and Drug Administration defended the drug's approval and a West Virginia Senator responded with a bill to force it off the market.
FDA Commissioner Dr. Margaret Hamburg told Senate lawmakers that the recently-launched Zohydro fills an "important and unique niche" for treating chronic pain. Her agency has been under fire for clearing the drug since December, amid concerns from lawmakers, addiction specialists and others that the drug will exacerbate the national epidemic of prescription drug abuse.
Zohydro is the first single-ingredient hydrocodone drug ever cleared for U.S. patients. Each extended-release pill contains up to five times more of the narcotic than previously available combination pills, such as Vicodin. Pharmacies began dispensing the drug earlier this week.
Hours after Hamburg's appearance on Capitol Hill, Senator Joe Manchin, D-W. Va., introduced a bill that would force the FDA to withdraw the drug and prohibit the approval of any similar medications that don't have tamper-resistant design features.
"I have tried reasoning with the FDA, and I've repeatedly requested the agency change its course on this dangerous drug," Manchin said in a statement. "Because of this painkiller's high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country."
Representative Stephen Lynch, D-Mass., introduced similar legislation in the House of Representatives.
In a statement late Thursday, Hamburg said the FDA has not had a chance to review the legislation.
To continue reading this article visit: http://www.foxnews.com/health/2014/03/14/fda-chief-defends-controversial-zohydra-painkiller-as-criticism-intensifies/
No comments:
Post a Comment