The Food and Drug Administration (FDA) issued a report that debunked a recent manufacturer sponsored clinical trial that argued the diabetes drug Avandia was safe to use.
This is not the first time that we have written about the dangers of Avandia. However, GlaxoSmithKline, the drugs manufacturer seems to have crossed a line this time. Dr. Thomas Marciniak of the FDA, found a dozen instances in the new study where patients taking Avandia suffered serious heart problems, but were not counted in the study.
Today, a panel of FDA experts are meeting to decide whether they should recommend the FDA have GlaxoSmithKline withdraw Avandia from the market or restrict its sale.
As we stated in our previous article, in numerous studies, including some conducted by GlaxoSmithKline themselves, Avandia has been shown to cause:
Edema, and fluid retention
Low blood pressure
However, Glaxo SmithKline has relied heavily on this new yet flawed study, named Record to defend Avandia from those claims.
Dr. Marciniak’s review of the Record study casts serious doubts on the trial. In one instance, a seizure patient was hospitalized for bleeding in the brain, but this incident was not mentioned in the study, a serious omission. In an even more severe case, a patient was hospitalized for two months following a stroke which was also wiped from the study.
Whats even scarier is the Dr. Marciniak believes that if he is given more time, he will dig up even more cases like these, but he has not yet had the chance to comb through all the records. We will have more information after the FDA concludes its conference today.
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