FDA Panel Says Avandia Should Stay

[Guest guest]

Dear All,

 

Again this may be off topic, but for those of you who also have to deal with

diabetes, this may be of importance to you.

FDA Panel Says Avandia Should Stay

(Ivanhoe Newswire) -- Despite recent studies suggesting the type-2 diabetes

drug Avandia (rosiglitazone) may cause serious cardiovascular problems, a U.S.

Food and Drug Administration advisory panel voted 22 to one for the medication

to remain on the shelves.

In July, researchers from Wake Forest University School of Medicine in

Winston-Salem, N.C., report thiazolidinediones, a class of drugs that includes

Avandia and Actos (pioglitazone), may double the risk of heart failure. Study

authors report that over a 26-month period, for every 50 type-2 diabetes

patients

taking one of the thiazolidinediones, one additional patient would develop

heart failure.

Earlier this year, an article published in The New England Journal of

Medicine revealed a link between Avandia and increased risk of heart attacks.

" In

view of the potential cardiovascular risks and in the absence of evidence of

other health advantages, except for laboratory measure of glycemic control, the

rationale for prescribing rosiglitazone at this time is unclear, " wrote Bruce

Psaty, M.D., Ph.D., and Curt Furberg, M.D., Ph.D., in the May 2007 article.

The FDA advisory panel met earlier this week to consider this, and other

research, before making the recommendation to the Agency, which is not required

to

follow the recommendation, though it usually has in the past.

The panel agreed there is evidence that Avandia does increase the risk of

heart attacks, and the makers of the drug will likely need to place new warnings

on the packaging.

This article was reported by Ivanhoe.com, which offers Medical Alerts by

e-mail every day of the week. To , click on:

_http://www.ivanhoe.com/newsalert/_ (http://www.ivanhoe.com/newsalert/) .

SOURCE: Diabetes Care, 2007:30:2148-2153; Ivanhoe interview with Bruce M.

Psaty, M.D., Ph.D.; The New England Journal of Medicine, published online May

21,

2007

 

 

 

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