FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia

FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia


Agency says drug to remain on market, while safety assessment continues

The U.S. Food and Drug Administration announced today that the
manufacturer of Avandia (rosiglitazone), a drug used to treat type 2
diabetes, has agreed to add new information to the existing boxed
warning in the drug's labeling about potential increased risk for heart
attacks.

People with type 2 diabetes who have underlying heart disease or who
are at high risk of heart attack should talk with their health care
provider about the revised warning as they evaluate treatment options.
FDA advises health care providers to closely monitor patients who take
Avandia for cardiovascular risks.

"FDA has moved expeditiously to review the cardiovascular risks of
this drug so that we could inform patients and doctors at the earliest
possible time of our findings," said Janet Woodcock, M.D., FDA's deputy
commissioner for scientific and medical programs, chief medical
officer, and acting director of the Center for Drug Evaluation and
Research. "FDA remains committed to making sure that doctors and
patients have the latest information about the risks and benefits of
medicines."

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa.,
was approved in 1999 as an adjunct to diet and exercise to improve
control of blood sugar levels. Avandia is approved to be used as a
single therapy or used in combination with metformin and sulfonylureas,
other oral anti-diabetes treatments.

During the past year, FDA has carefully weighed several complex
sources of data, some which show conflicting results, related to the
risk of chest pain, heart attacks and heart-related deaths, and deaths
from any cause in patients treated with Avandia.

At this time, FDA has concluded that there isn't enough evidence to
indicate that the risks of heart attacks or death are different between
Avandia and some other oral type 2 diabetes treatments. Therefore, FDA
has requested that GSK conduct a new long-term study to evaluate the
potential cardiovascular risk of Avandia, compared to an active control
agent. GSK has agreed to conduct the study and FDA will ensure it is
initiated promptly.

The revision of Avandia's existing boxed warning – FDA's strongest form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months;
14,237 total patients), most of which compared Avandia to placebo,
showed Avandia to be associated with an increased risk of myocardial
ischemic events such as angina or myocardial infarction. Three other
studies (mean duration 41 months; 14,067 patients), comparing Avandia
to some other approved oral antidiabetic agents or placebo, have not
confirmed or excluded this risk. In their entirety, the available data
on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in
class of drugs related to Avandia) on Aug. 14, 2007, emphasized that
these types of drugs may worsen heart failure, a condition in which the
heart does not adequately pump blood, in some patients.
GSK is
also developing a Medication Guide for patients to provide additional
information about the benefits and risks and safe use of Avandia.

To date, no oral anti-diabetes drug has been conclusively shown to
reduce cardiovascular risk. Consequently, the agency also will be
requesting that labeling of all approved oral anti-diabetes drugs
contain language describing the lack of data showing this benefit.

Today's action follows recommendations made at the July 2007 joint
meeting of FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk
Management Advisory Committees. At the meeting, members voted 22-1 to
recommend that Avandia stay on the market, pending a review of
additional data. The committee also advised that information warning of
the potential for increased risk of heart attacks should be added to
the drug labeling.

For more information:

Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm

FDA Issues Safety Alert on Avandia

www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html

Legal Assistance and consumer Forums 

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