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.
In 2000, Rezulin diabetes drug was recalled after being linked to dozens of fatal liver disease instances. The drug, which concentrated in the liver and was broken down by liver enzymes, was blamed for more than 60 deaths from liver failure.
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 drug of the newest class. After the recall of Rezulin, Avandia and Actos were kept on the market and touted as safer alternatives.
Not long thereafter, Avandia began to draw suspicion. Several studies indicated that patients taking Avandia should have their liver enzymes monitored regularly. In the years since, Avandia 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 an increased 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).
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. If you or a loved one have have developed heart, liver, lung or bone damage, please fill out the contact form to your right and an attorney experienced in Avandia litigation will help determine if a lawsuit is warranted.
Lawsuits of Interest
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