Issue 17, March
2. Diabetes Drug May be Banned Soon

     It was in 2007, that the first report of rosiglitazone producing heart attacks and deaths in diabetes subjects got published in New England Journal Of Medicine. All through out Dr. Steven E. Nissen stood firm in his findings of the blockbuster drug Avandia directly related to not just heart failure but also heart attacks.

     The drug is the latest example of why Dr. Nissen, 58, whose day job is chairman of cardiovascular medicine at the Cleveland Clinic, has emerged as a Naderesque figure and the nation’s unofficial arbiter of drug safety.
Dr. Nissen, who had warned of the dangers of the painkiller Vioxx, from Merck, before it was withdrawn in 2004, had also challenged Merck’s follow-on product, Arcoxia, which failed to win approval. He called Arcoxia the “son of Vioxx,” telling a reporter, “This is a genie I don’t want to see let out of the bottle.”
(Read more in New York Times)

     Rosiglitazone is marketed alone or in combination with metformin or with glimepiride under different names in different parts of the world. Avandia, Windia, Avandryl, Avandamet etc etc., are only some among them. Unfortunately millions of diabetic patients are still consuming this drug under different trade names not knowing that they are using rosiglitazone. Since diabetes per se raises the risk of heart attacks by more than 3 to 4 times, it is difficult perhaps to blame rosiglitazone as the culprit. However subsequent studies and recent observations have once again confirmed the fact.

     At present it is unknown whether glitazone as a class is hazardous. Pioglitazone despite its tendency to produce edema, heart failure and weight gain could still be cardio protective. But we need to wait and see whether pio will also disappear from the market in the coming years. From the recent observations it is evident that FDA may go ahead with completely banning rosiglitazone within the next couple of months.


Dr. Steven.E.Nissen

 
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