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Avandia Facts
Several studies have indicated that patients taking Avandia to control their diabetes should have their liver enzymes monitored regularly. In the years since the recall of Rezulin, the diabetes drug recalled in 2000 after being linked to more than 60 deaths from liver failure, Avandia has always been under suspicion and has continually come under fire for its possibly damaging effects on the liver and its link to hepatitis and other liver diseases. Avandia has also been linked to chronic heart disease, especially when taken in conjunction with insulin. Recent studies have found that people with chronic heart disease should be warned against taking Avandia, as it can cause fluid retention and edema (excessive swelling, usually of hands and feet). These symptoms flag problematic heart conditions. Avandia has also been linked to primary pulmonary hypertension, a serious, incurable heart disease. A recent study monitoring the outcome and progression of certain diabetes treatments found an association between females taking rosiglitazone-based drugs and anincreased
incidence of bone fractures. Female patients injured while being treated with rosiglitazone-based drugs like Avandia typically suffered fractures in the upper arm, hand, or foot. Although there was discussion of whether or not such fractures may be associated with postmenopausal osteoporosis, it was determined that the rosiglitazone-based fractures (upper arm, hand, or foot) were not in line with the typical postmenopausal osteoporosis fractures (hip or spine).
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Usage
Rosiglitazone is an anti-diabetic drug from the thiazolidinedione class. It is being marketed as Avandia by the pharmaceutical company GlaxoSmithKline, both as a standalone preparation
and in combination with metformin (Avandamet). Another combination drug approved by the FDA is Avandaryl (with glimepiride). Approved by the FDA in 1999, Avandia has proven successful in controlling blood sugar in adults with type-2 diabetes. Type-2 diabetes develops when the pancreas cannot produce enough insulin, or the body''s tissues become resistant to insulin. The disease, which used to be called adult-onset diabetes or non-insulin-dependent diabetes mellitus, can be treated without using insulin.
Litigation
The FDA announced at the time of Rezulin recall that Actos and Avandia were safer alternative in "this important class of diabetes drug," which Rezulin was the first FDA approved drugof the newest class. After the recall of Rezulin, Avandia and Actos were kept on the market and touted as safer alternatives. Lawsuits against the manufacturer, GlaxoSmithKline, have sought damages for people who have developed injuries as a result of taking Avandia. In 2001, the FDA required the
manufacturer to change the label to warn patients of possibly fatal consequences, however the damage may have already been done to thousands of people unknowingly taking the drug
before the warning label existed.
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