Swiss researchers recently concluded that Avandia, a type 2
diabetes drug, nearly doubles the chances of osteoporosis
and bone fracture among patients who take the drug and is
increased for patients taking the drug for more than a
year. The results of the study come on heels of controversy
surrounding the drug's link to increased heart disease and
various studies warning of potential risks related to bone
degradation.
The type 2 diabetes drug was introduced to the market in
1999 from GlaxoSmithKline, and has been reportedly
prescribed to nearly 3.5 million Americans suffering from
the disease. Avandia was once considered one of the most
popular treatments until results of several clinical trials
reported in the news in 2007 determined a strong connection
of the drug to cardiomyopathy and cardiovascular disease.
One study, published by the Cleveland Clinic, found a 43
percent increase for patients developing these various
heart diseases. Dr. John Buse, an expert on diabetes, has
openly stated that Avandia may have been responsible for
approximately 83,000 preventable myocardial infarctions
over the last few years.
Additional studies then began to surface linking the drug
to an increased risk of osteoporosis, although many of the
studies did not have definitive proof of the connection
until the recent Swiss study was published. The Swiss study
determined patients on Avandia and Actos, which is also
part of the Avandia class of drugs known as
thiazolidinediones, doubled and, in some cases, tripled the
"odds of non-spine fractures" among patients, according to
news reports. For patients who took the drug for 12 to 18
months, this risk increased, and for those on the drug
longer than two years were found to be at the highest risk
of bone fracture and osteoporosis.
Osteoporosis is a disease characterized by loss of bone
density and leads to abnormally porous bones, thus
increasing the fragility of bones and an increase of
fractures and breaks. A bone diseased with osteoporosis
will have a density similar to that of a sponge, whereas
healthy bones have a brick-consistent density level. Bones
are made up of collagen, calcium and protein to ensure
strength. Avandia was found to inhibit the development of
osteoclasts and osteoblasts, which are cells that induce
the redevelopment of healthy bone over time. It has been
suggested that nearly 18 million Americans are at risk for
osteoporosis and those taking Avandia increase that risk as
well as the odds for early onset osteoporosis.
The Swiss researchers used medical records of over 1,000
diabetic patients who were diagnosed with bone fractures
between the years of 1994 and 2005. The medical records
included diagnosis of fractures for these patients from
British physicians, and the research was compared to a
control group of diabetics that did were not diagnosed with
bone fractures during that time. Since these reports began
to surface the manufacturer has seen a noticeable decline
in sales. Most recently, the U.S. Food and Drug
Administration (FDA) issued a warning letter to
GlaxoSmithKline after a routine inspection turned up
information being withheld by the company to the FDA on
Avandia.
Although, the FDA has yet to address the new research on
the osteoporosis and bone fracture risk of Avandia. In
fact, the FDA has only responded to the controversial heart
disease link by placing a black box warning on Avandia
prescriptions, which some health experts consider to be a
mild slap on the wrist considering the severe safety issues
associated with the drug and many of these individuals are
advocating removal of the drug from the market. The black
box warning is the strongest label given by the FDA and
warns of significant risk and the potential for
life-threatening risks associated with taking a drug.
Individuals who have taken Avandia and who were adversely
affected by the side effects of osteoporosis and bone
fracture should speak with a pharmaceutical attorney about
developing Avandia litigation to potentially receive
monetary compensation for the medical bills incurred at the
cost of the Avandia side effects.
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