Avandia to be Withdrawn from the Market by End of the Year

by Kathy Jones on  May 19, 2011 at 4:52 PM Drug News   - G J E 4
GlaxoSmithKline's diabetes drug, Avandia will be pulled off the shelves by the end of November after a number of studies showed that the drug increased the risk of heart attacks among type 2 diabetes patients.
 Avandia to be Withdrawn from the Market by End of the Year
Avandia to be Withdrawn from the Market by End of the Year

A report published in 2007 by Cleveland Clinic's Steven Nissen showed that it increased the risk of heart attacks in more than 40 percent of Avandia users. The FDA's drug safety expert, David Graham also revealed that Avandia was responsible for heart problems, which sometimes turned fatal, in 66,000 to 200,000 people.

According to GSK's Bernadette King, nearly half a million Avandia prescriptions were filled out by October of last year while more than 90,000 people were using the medicine in December. The FDA's new program will kick into effect on November 18, though a number of critics have said that the order has come late in the day.

"The decision was made last year that this was needed. Now they're finally announcing that we're finally going to have restrictions six months from now. It has taken more than a year to ensure that patients are truly informed of the risk", one of Yale's leading cardiologist, Harlan Krumholz said.

Source: Medindia

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How come they have not established the connection of Avandia and heart attacks in clinical trials?
ennairam_23 Thursday, May 19, 2011
yes ennairam_23.its a curious case..actually in phase 4 studies they concluded there is no fatal SAE and the AE reported in the study population was hyperlipidaemia [9.77%], upper respiratory tract infection(6.11%) and oedema(5.32%).It seems the clinical DATA is cooked up..??
Rasal Friday, May 20, 2011

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