What is Avandia? What are its Side Effects?
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Avandia is a drug developed by GlaxoSmithKline for people suffering from type 2 diabetes mellitus. Type 2 diabetes is also referred to as “adult-onset” diabetes and “non-insulin dependent” diabetes. It is caused when a person’s body does not make enough insulin, or when their body cannot respond appropriately to its insulin production.
Avandia treatment is intended to lower blood sugar when used in conjunction with an appropriate diet and exercise. Avandia can also be used in association with other diabetes drugs to best target the condition and its effects. Avandia is taken in tablet form in a starting dose of 4mg (once a day) or 2mg (twice a day). While it has been found to aid in the treatment of type 2 diabetes, it has been associated with certain side effects, notably the issue of increased incidence of bone fracture in female patients.
Although Avandia has proven to be an effective mode of treatment of people suffering from type 2 diabetes mellitus, it has also been linked with the development of some serious side effects. Recent studies have linked Avandia with serious cardiovascular problems including heart attack and cardiovascular death. In fact, the latest study published in the American Diabetes Association medical journal concludes that side effects of Avandia may double the risk of heart attack when compared to other types of diabetes drugs.
Patients taking Avandia may also be at risk of developing a cardiovascular disease called primary pulmonary hypertension (PPH). While PPH is most commonly associated with a higher-than normal blood pressure in the pulmonary artery, it has also been shown to be associated with the development of heart valve disease and/or heart valve defects. Avandia patients who develop PPH may be entitled to receive compensation.
Avandia Black Box Warning
The controversy surrounding popular diabetes drug Avandia continues to grow as new information comes out regarding GlaxoSmithKline’s knowledge of Avandia heart risk.
A June 6, 2007 congressional hearing in Washington yielded damning information from a medical expert who testified that he approached the pharmaceutical company in 1999 with information related to Avandia heart risk. His testimony detailed legal threats issued by GlaxoSmithKline executives (then SmithKline Beecham) if he were to make noise regarding the serious cardiovascular side effects associated with the diabetes drug. On June 7, 2007, the Food and Drug Administration took action against GlaxoSmithKline by requiring a “black box” warning for Avandia that would alert consumers to the cardiovascular risk. “Black box” warnings are the most serious required by the FDA, and one-step closer to recall.
In addition to Avandia, the FDA will also require that Takeda Pharmaceuticals’ Actos include the same “black box” warning.
Avandia Update
On November 14th, 2007, the FDA added a second Black Box warning to Avandia for heart attack risks - The New England Journal of Medicine published a study in May of 2007 that found a 43 percent increase in heart attacks for Avandia users. A panel voted to allow the diabetes drug to remain on the market, though the FDA has directed GlaxoSmithKline to initiate a new study to determine long-term cardiovascular risks. The FDA
This most recent Black Box warning follows the analysis of 42 clinical studies evaluating the efficacy of Avandia. The studies involved more than 14,000 patients and found a link between the use of Avandia and an increased risk of heart attack.
Avandia Lawsuits
GlaxoSmithKline is currently facing a slew of additional product liability lawsuits following expert testimony that Avandia could be responsible for more than 100,000 heart attacks since it was first introduced in 1998.
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for personal injury litigation. The law offices of Aylstock, Witkin, Kreis and Overholtz boast some of the most experienced personal injury lawyers, Pensacola, FL, has to offer. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by drugs. Contact AWKO law today at (888) 255-AWKO (2956) to get more information about your rights as an Avandia injury victim. The lawyers of AWKO Law are skilled attorneys who can also help Pensacola wrongful death victims and those who have been injured by defective medical devices or recalled drugs.
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Aylstock, Witkin, Kreis & Overholtz
803 North Palafox St.
Pensacola, Florida 32501
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Gulf Breeze, Florida 32561
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