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Warning Letter, 2001

in this section: Firm's Press Release, 10.1.07 | Another FDA Warning? 10.24.07 | avandia drug warning | Study Reveals Risks, 6.6.07 | FDA Warning, 5.22.07 | Secret Avandia Vote | Veterans Affairs: Avandia | FDA Approval of Avandia | NEJM Study | Warning Letter, 2001 | Sales Plunge | NEJM Update, 6.5.07 | FDA Safety Information | FDA Warning, 6.6.07 | Scientists Silenced | Dallas Lawsuit | Patients Switch Meds | Avandia Prescriptions Fall | Updated Study, 7.12.07 | Avandia Panel, 7.25.07 | Second Black Box? | Senators Testify | Experts Cite Risks | Black Box Warning | 9.12.07 Study Analysis | Actos Study | Arkansas Lawsuit | Weakens Bones | JAMA Report, 12.7.07 | Avandia Diabetes Pills | Avandia Warning

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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:

Avandia Panel, 7.25.07 Academic Panel of Scientists to Meet With FDA Regarding Avandia Risks
Scientific Panel to Advise FDA on Avandia Heart Attack Risk

Updated Study, 7.12.07 Latest News on Avandia: German Study Adds More Reasons to Avoid it
Latest Study in the News: Avandia May Worsen Complications of Diabetes

News & Warnings Avandia Breaking News: Glaxo Warned in 2001 about Misleading Marketing
Bloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001

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