FDA Issues Safety Alert on Avandia

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FDA Issues Safety Alert on Avandia

ROCKVILLE, MD -- May 21, 2007 -- The U.S. Food and Drug

Administration (FDA) is aware of a potential safety issue related to

Avandia (rosiglitazone), a drug approved to treat type 2 diabetes.

Safety data from controlled clinical trials have shown that there is

a potentially significant increase in the risk of heart attack and

heart-related deaths in patients taking Avandia. However, other

published and unpublished data from long-term clinical trials of

Avandia, including an interim analysis of data from the RECORD trial

(a large, ongoing, randomized open label trial) and unpublished

reanalyses of data from DREAM (a previously conducted placebo-

controlled, randomized trial) provide contradictory evidence about

the risks in patients treated with Avandia.

 

Patients who are taking Avandia, especially those who are known to

have underlying heart disease or who are at high risk of heart

attack should talk to their doctor about this new information as

they evaluate the available treatment options for their type 2

diabetes.

 

FDA's analyses of all available data are ongoing. FDA has not

confirmed the clinical significance of the reported increased risk

in the context of other studies. Pending questions include whether

the other approved treatment from the same class of drugs,

pioglitazone, has less, the same or greater risks. Furthermore,

there is inherent risk associated with switching patients with

diabetes from one treatment to another even in the absence of

specific risks associated with particular treatments. For these

reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to

take any specific action at this time. FDA is providing this

emerging information to prescribers so that they, and their

patients, can make individualized treatment decisions.

 

" FDA remains committed to assuring that doctors and patients have

the latest information available to make treatment and medication

use decisions. In this case, FDA is carefully weighing several

complex sources of data, some of which show conflicting results,

related to the risk of heart attack and heart-related deaths in

patients treated with Avandia, " said Steven Galson, M.D., M.P.H.,

director of FDA's Center for Drug Evaluation and Research. " We will

complete our analyses and make the results available as soon as

possible. FDA will take the issue of cardiovascular risk associated

with Avandia and other drugs in this class to an Advisory Committee

as soon as one can be convened. "

 

Avandia was approved in 1999 for treatment of type 2 diabetes, a

serious and life threatening disease that affects about 18 to 20

million Americans. Diabetes is a leading cause of coronary heart

disease, blindness, kidney failure and limb amputation. Since the

drug was approved, FDA has been monitoring several heart-related

adverse events (e.g., fluid retention, edema and congestive heart

failure) based on signals seen in previous controlled clinical

trials of Avandia alone and in combination with other drugs, and

from postmarketing reports. FDA has updated the product's labeling

on several occasions to reflect these new data, most recently in

2006. The most recent labeling change for Avandia also included a

new warning about a potential increase in heart attacks and heart-

related chest pain in some individuals using Avandia. This new

warning was based on the result of a controlled clinical trial in

patients with existing congestive heart failure.

 

Recently, the manufacturer of Avandia provided FDA with a pooled

analysis (meta analysis) of 42 randomized, controlled clinical

trials in which Avandia was compared to either placebo or other anti-

diabetic therapies in patients with type 2 diabetes. The pooled

analysis suggested that patients receiving short-term (most studies

were 6-months duration) treatment with Avandia may have a 30-40

percent greater risk of heart attack and other heart-related adverse

events than patients treated with placebo or other anti-diabetic

therapy. These data, if confirmed, would be of significant concern

since patients with diabetes are already at an increased risk of

heart disease.

 

Avandia is manufactured by GlaxoSmithKline, which is based in

Research Triangle Park, N.C.

 

 

SOURCE: FDA

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