GlaxoSmithKline, makers of the type 2 diabetes prescription
drug known as Avandia, recently received warnings from the
U.S. Food and Drug Administration (FDA) after the company
withheld post-marketing research information on Avandia.
Avandia, also known as its generic name rosiglitazone
maleate, is an oral medication used to control an
individual's blood sugar level as well as continue to
regulate sugar levels. Avandia was once reportedly the
best-selling diabetic drug around the world, however, a
study published in the New England Journal of Medicine
reported results from clinical trials of the drug, which
found Avandia to have severe side effects on individuals
both with a history of heart disease and without.
The report, released in May 2007, found that patients were
more likely to suffer from heart disease after taking
Avandia for a period of time and individuals with a history
of heart disease were likely to suffer a worse outcome, as
the drug increased the ill-effects of heart disease among
patients and resulted in death from cardiovascular-related
causes. In fact, the study found a 43 percent increased
risk of myocardial infarction, otherwise known as a heart
attack. Both regulators in the United States and in Europe
increased warning labels of Avandia's prescribing
information as a result of the May 2007 report and sales
have dropped by nearly half, according to news reports.
The warning letter from the FDA came after GlaxoSmithKline
failed to meet their deadline for reporting the results and
research of 10 ongoing clinical trials of Avandia. Federal
regulations require that the companies provide FDA
officials with updates of the after-market studies. The
Avandia studies were over a six-year period ranging from
2001 to 2007. In November 2007 the FDA completed a routine
inspection of the company and drug. Officials found that
information from the trials was not adequately presented
and information remained missing.
GlaxoSmithKline responded by stating that the information
that was withheld from FDA officials had nothing to do with
the potential safety risks of the drug and since the FDA
inspection, the company has claimed that new training
methods and programs have been implemented to avoid the
loss of data reported to the FDA.
Avandia was approved for market in May 1999 and has been
used as a potential drug to benefit Alzheimer's disease as
well as to treat type 2 diabetes. Currently, there are
approximately 3.5 million individuals taking Avandia,
although, that number has likely decreased with the
continuation of negative reports surrounding the drug. In
addition to the risk of heart disease, Avandia has been
associated with other serious side effects including an
increased risk of osteoporosis and bone fractures among
patients. Researchers from the Salk Institute for
Biological Studies have found that Avandia disrupts the
natural process of osteoblasts and osteoclasts, the two
types of cells in the body the work to renew old bone
growth with new, strong and healthy bone; although clinical
trials are ongoing.
Other common side effects of the drug include headache,
inflammation of sinuses, weight gain, back pain, swelling
or fluid retention. Individuals who have taken Avandia and
been victim to the serious side effects of the drug should
speak with an experienced pharmaceutical attorney, as the
potential for an Avandia lawsuit exists and may result in
monetary compensation for the damage done to an
individual's health.
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To learn more about Avandia, visit the LegalView homepage
at http://avandia.legalview.com/ . Here you will learn
about the latest clinical trial results of the drug and be
able to link to the LegalView homepage, at
http://www.LegalView.com , to learn about other
controversial drugs such as the Baxter Heparin recall and
the Chantix side effects.
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