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Is the FDA really looking out for you?
The FDA mission statement reads in part: “The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products …, our Nations food supply …” “The FDA is also responsible for … helping the public get the accurate, science based information they need to use medicines and foods to improve their health.” With that mission statement in mind, let’s take a look at this tragic situation: As reported by the Associated Press on February 14th, 2005 – Canada has ordered the removal of a drug for ADHD – Adderall XR, Because of links to 20 sudden deaths and 12 strokes from people taking this drug. 14 of these deaths were children and 2 of the 12 strokes were children who were taking the drug. None of these deaths or strokes took place in Canada and none of the reactions were from misuse or abuse of the drug. The reactions were from normal consumption of the drug. Canada is also asking makers of similar drugs for treating this condition, “to provide a thorough review of their worldwide safety data.” In stark contrast to the Canadian reaction, here is the statement from the United States FDA – “The U.S. Food and Drug Administration, however, said it had evaluated the same reports on Adderall XR and doesn’t think the data warrants similar action in the United States.” Let’s get this straight – Canada has ordered the drug to be pulled off the market in their country. And the FDA says it is alright that 2 children have suffered strokes and 14 children have died from using this drug. Canada cares about the health of its children and does not want any deaths to happen in their country. However, the FDA has a very different view. This is the FDA statement posted on their website last week: The FDA says it “does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada’s analysis of adverse event reports and FDA’s own knowledge of the reports received by the agency.” When will the FDA care about America’s children? When will the FDA care about the people of America? Let’s review the FDA mission statement one more time. “The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products …, our Nations food supply …” “The FDA is also responsible for … helping the public get the accurate, science based information they need to use medicines and foods to improve their health.” I’m not sure when you’ll be asking yourself, “Is the FDA really looking out for my health?” Sources: Associated Press “Canada orders drug for ADHD off market”, February 14th, 2005. Nutritional Health Alliance, Washington Update, February, 2005.
This article was posted on February 16, 2005
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