Avandia, a type 2 diabetes drug, has long been alleged to be responsible for an increased risk of heart disease, but it wasn't until recently that Swiss scientists found conclusive evidence linking the drug to early onset osteoporosis.
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 suffer from the condition. 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.
It wasn't until the Swiss research that conclusive evidence was reported on the serious risk of osteoporosis link. 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. Nearly 18 million U.S. citizens are at risk for osteoporosis. While taking Avandia, that risk has been suggested to only increase.
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.
However, the risk of osteoporosis and Avandia consumption has not be recognized by the FDA. 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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