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FDA Announces Severe Avandia Restrictions

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Washington, DCThe US Food and Drug Administration (FDA) has decided that it will severely restrict sales of Avandia, following recommendations made by its advisory panel and critics of the drug who were concerned about serious Avandia side effects. Meanwhile, in Europe, sales of the diabetes medication will be completely suspended due to concerns about Avandia risks.

According to The New York Times (09/23/10), the FDA announced that patients in the US will only be allowed to take Avandia if they and their doctors can show they have tried every other diabetes medication available. Furthermore, they must prove they have been made aware of Avandia side effects, which include an increased risk of heart attacks.

Patients who currently take Avandia and are benefiting from its use will be allowed to choose whether or not they continue to use it.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research noted in an article concerning the FDA's announcement that the decision was based on, "multiple signals of concern, from varied sources of data, without reliable evidence that refutes them." (at Woodcock further noted the lack of evidence of cardiovascular ischemic risk with Actos and stated that the Office of Suveillance and Epidemiology recommended full market withdrawal or restricted access to Avandia.

According to the FDA's announcement, Avandia is allowed to remain on the market because of conflicting data about the magnitude and risk of cardiovascular side effects and because there are individuals who may still benefit from Avandia when no other medication will help them.

The FDA has also announced that the TIDE trial, which compares Avandia to rival drug Actos, must be stopped. Furthermore, GlaxoSmithKline, maker of Avandia, was ordered to have an independent assessment of its RECORD trial conducted. An FDA medical officer said the trial was full of errors that could have biased the results.

Woodcock noted in her announcement that the TIDE trial will be stopped because, "the results of RECORD [a previous trial concerning the safety of Avandia], which are currently in question, directly affect the ethics of conducting TIDE." Due to this, she has ordered that the RECORD trial undergo further analysis before decisions on continuing with further studies of Avandia are made.

Meanwhile, Avandia will no longer be available for sale in Europe.

Patients who are currently taking Avandia are advised not to discontinue the medication without speaking to their doctors. GlaxoSmithKline said in a statement it believes Avandia is safe.


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