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Tuesday, June 9, 2009
Public Citizen Group Petitions the FDA for stronger warning on Amitiza
Amitiza is a medication that was approved by the FDA in Janaury 2006 for the treatment of chronic constipation and later approved in 2008 for treatment of irritable bowel syndrome. However, this medication can have deadly side effects. The advocay group, Public Citizen, has filed a petition with the FDA requesting that Amitiza carry a stronger warning for pregnant women about the risk of early child birth and unintended abortions. In early May 2009, Public Citizen sent their petition to the FDA requesting that not only a "black boxed" warning be prominently displayed, but also that a "Dear Doctor" letter be sent to healthcare providers to inform them about the risks. It is absolutely imperative that all steps be taken to warn women of these terrible side effects associated with the medication, Amitiza. According to the director of Health Research Group at Public Citizen, "The curernt label is grossly inadequate as it lacks useful informaiton pertaining to the risks of drug-induced abortion in pregnant women who take the drug."
Labels: Amitiza, Public Citizen, irritable bowel syndrome, chronic constipation
Labels: Amitiza, Public Citizen, irritable bowel syndrome, chronic constipation
posted by
Kristine Kraft
at
3:17 PM
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