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Avandia Diabetes Drug Effects Under FDA Scrutiny

News of Avandia diabetes drug effects under FDA scrutiny came early July 2010. Food and Drug Administration committee (FDA) commitee delivered a divide verdict on the diabetes drug Avandia on 14 July 2010. Pressure on Avandia diabetes drug, made by GlaxoSmithKline, mounted as a scientist from FDA questioned the conduct of a trial measuring the cardiovascular safety of the medicine.

GlaxoSmithKline is the maker of Avandia diabetes drug, which is getting heavy fire from both the FDA and the European Medicines Agency. Both drug guard dog will be meeting over the next few weeks to look into multiple disciplines formerly performed on the drug which indicate that it brings up the danger of heart problems in those taking it.

FDA will review over 7,000 pages of data on Avandia to find out if it is really presenting a health risk to those taking it. There has data released from as far back as year 2005 that does in reality present that the drug is unsafe, and GlaxoSmithKline is facing multiple lawsuits as a effect of people getting heart problems from it.

Last year, GlaxoSmithKline released the results of the study, which showed Avandia was not associated with an increment in cardiovascular hospitalisation or cardiovascular death compared with patients receiving two other commonly used diabetes drugs.

GlaxoSmithKline has insisted on the safety of the medication, which is used to control blood sugar levels in diabetics. GlaxoSmithKline overall conclusion was that the data from Record was robust and reliable, and the conduct of the study was done to good clinical practice standards.

Britain's biggest drug company submitter a comprehensive review to the panel showed Avandia was safe, adding that results have been seen from six controlled clinical trials dealing with the cardiovascular safety of Avandia since 2007. Collectively, they indicate that this medicine does not increase the overall risk of heart attack, stroke or death.

However, a study published in 2007 that linked Avandia to an increased risk of heart attacks and other related problems has caused annual sales of Avandia to dropped from about $3 billion in 2006 to about $1 billion.

Presently, Avandia diabetes drug accompanies a warning of increased heart failure risk, and with many diabetic battling their weight. The FDA committe can recommend the drug be withdrawn from the market if it decide that risks associated with the drug greater than its benefits. Despite all the damning data, the drug remains on the market for now.

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