Avandia Generic (Rotiglitazone)

Read the Warning Letter from 2001 on Avandia(Generic Rotiglitazone)

Upon reading of the significant risk to cardiovascular problems for users of Avandia (generic rotiglitazone) in the June 2007 New England Journal of Medicine, Senator Kennedy posed the following question in a press release:

"why did the American public have to wait more than 8 years and depend on a group of independent scientists to conduct this study before we learn of a major safety concern with this drug?"

This question is all the more compelling considering that GlaxoSmithKline was alerted to the possible dangers the pill posed to users many years ago.

In a letter to JP Garnier, CEO of Glaxo, Thomas W. Abrams, Director, Division of Drug Marketing, Advertising and Communications, wrote the following:

"DDMAC has concluded that GSK has promoted Avandia in violation of the Federal Food Drug, and Cosmetic Act...Your promotional activities that minimize serious new risks are particularly troublesome..."

Abrams was referring to clinical studies that shed light on an increased incidence of heart failure and other cardiovascular events seen in patients on Avandia and insulin combination therapy compared to insulin or a placebo.

The NEJM meta-analysis from this year, found that Avandia taken alone raised the risk of heart problems, as compared to patients on a placebo or other diabetes drugs.

The public was finally alerted to the serious health risks on Monday, May 21, 2007, when the Food and Drug Administration released the information.

If you or a loved one has suffered cardiac complications after ingesting Avandia, you deserve the guidance of an experienced drug attorney. Get a free case review by filling out the form below.

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see also:

FDA Warning, 10.24.07 New Avandia Setback? Possible Second Black Box Warning on Heart Attack
GlaxoSmithKline May Get New Avandia Black Box Warning for Heart Attack

Warning Letter, 2001 Avandia Generic (Rotiglitazone) | Weitz & Luxenberg
Warning Sent to Glaxo Years Ago on Avandia (generic Rotiglitazone)

Avandia Warning Avandia Drugmaker Gets FDA Warning Letter Over Health Risks
Warning letter cites failure to disclose studies about Avandia risks