Shevlin Smith Blog

Is The FDA Doing Its Best To Protect American Citizens From The Risks Of Drug Medications?

Avandia is a diabetes drug designed to lower a diabetic's blood sugar and kept it under control. As such, one of its aims is to protect against the risks of uncontrolled diabetes, including the risk of heart disease.  The drug is made by GlaxoSmithKline.

Ironically, in May, reports began to surface that instead of protecting diabetics from heart disease, Avandia was actually having the opposite effect.  A study published in the New England Journal of Medicine found that the use of Avandia increased a patient's risk of heart attacks. Another more recent study published in the Journal of American Medical Association found similar risks to patients, noting that the use of the drug doubled the risks of heart failure and raised the risks of heart attack by 42 percent.

A number of physicians have called for the withdrawal of Avandia from the market.  A safety scientist at the Food and Drug Administration joined in that call arguing that Avandia's toxic effects on the heart had caused up to 205,000 heart attacks and strokes, some fatal, from 1999 to 2006.  Regardless, the Food and Drug Administration overwhelming voted otherwise.  Instead, the FDA has required GlaxoSmithKline to place strict warnings on Avantia labels. 

Of particular interest, FDA officials have admitted that GlaxoSmithKline told the agency about heart risks nearly two years ago but that because of internal disagreements, it never warned patients.  

This, of course, leads to the question is the FDA really doing everything within its power to help protect the American public?