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Approved by the FDA in 1999, AvandiaŽ 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.
AvandiaŽ was formerly thought to be a safer alternative to treatment of type-2 diabetes than another existing diabetes medication, Rezulin, which was recalled in 2000 due to its association with liver failure. The drug, which concentrated in the liver and was broken down by liver enzymes, was blamed for more than 60 deaths from liver failure.
After the recall of Rezulin, which left half a million type-2 diabetes patients searching for a new medication, two other drugs in the same family (called thiazolidinediones or glitazones) were kept on the market. AvandiaŽ and Actos were said to be safer alternatives, and AvandiaŽ quickly became a big seller.
Soon after, AvandiaŽ began to draw suspicion over its safety, as well. Several studies indicated that patients taking AvandiaŽ should have their liver enzymes monitored regularly. In the years since, AvandiaŽ has continually come under fire for its possibly damaging effects on the liver and its link to hepatitis and other liver diseases.
AvandiaŽ has also been linked to chronic heart disease, especially when taken in conjunction with insulin. Although one benefit of the drug was that in many cases it didn''t require the patient to take insulin, some other patients needed to take insulin at least temporarily. This combination has proven detrimental.
Recent studies have found that people with chronic heart disease should be warned against taking AvandiaŽ, as it can cause fluid retention and edema (excessive swelling, usually of hands and feet). These symptoms flag problematic heart conditions. AvandiaŽ has also been linked to primary pulmonary hypertension, a serious, incurable heart disease.
AvandiaŽ lawsuits against the manufacturer, GlaxoSmithKline, have sought damages for people who have developed heart disease as a result of taking AvandiaŽ. 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. A consultation with an attorney experienced in AvandiaŽ litigation will help determine if a lawsuit is warranted.
Protect your legal rights by contacting our experienced AvandiaŽ attorneys today. You may be entitled to compensation for your losses, including the cost of medical treatment, mental anguish, and pain and suffering, among other things.
The FDA announced that is has made a change regarding cardiovascular risks to the Avandia® (rosiglitazone) label and patient Medication Guide, Feb. 4, 2011.
The FDA announcement also said that Avandia®'s drug label was updated ...
A government run diabetes trial was halted 18 months early after a safety analysis revealed an increased risk of death in patients whose blood sugar levels dipped too low.
The 10,000 patient trial was examining the effectiveness of aggressive ...
A new study published in the Journal of the American Medical Association reaffirms previous findings about the diabetes drug Avandia—that is, it carries a significantly increased risk of heart failure, heart attack, and death.
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