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.
see also:
Avandia Diabetes Pills
Glaxo Failed to Disclose Studies Regarding Avandia Diabetes PillsFDA wasn't told about safety reports on Avandia Pills--lawsuit info
Firm's Press Release, 10.1.07
Weitz & Luxenberg Lawyers Respond to Study Casting Doubt on AvandiaW&L Lawyers React to Growing Scientific Evidence Against Avandia
News & Warnings
Avandia Breaking News: Glaxo Warned in 2001 about Misleading MarketingBloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001
