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Pharmaceutical
Injuries - Avandia
Have
You Sustained a Personal Injury from Avandia?
Avandia
lawsuits have resulted because of the serious Avandia
side effects that have been reported. When the Rezulin diabetes drug was
recalled, Avandia was intended to replace it as a safer alternative. Avandia
lawsuits have resulted because serious side effects as a result of using Avandia have surfaced, including congestive heart
failure, hepatitis, and liver failure.
Avandia (rosiglitazone) is used by more than 2 million people to treat "type-2" or "adult-onset" diabetes, and is manufactured by GlaxoSmithKline. Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation.
Avandia and Adverse Health Effects
Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia.
Advice for Patients
The FDA is advising patients who are taking Avandia -- especially those who are known to have underlying heart disease or who are at high risk of heart attack -- to talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.
Pending questions on the safety of Avandia include whether another approved drug (pioglitazone) has less, the same, or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.
Avandia Recent News
November 14, 2007: Heart Attack Risk Added to Avandia Labeling
Labeling on the diabetes drug Avandia will now carry a boxed warning of increased heart attack risk, according to an Error! Bookmark not defined. (FDA). The warnings will state that studies "have not confirmed or excluded" the risk of heart attack and chest pain associated with Avandia use, because data evaluated by the FDA shows that "there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments."
September 12, 2007: JAMA Studies Show Avandia Heart Risk
Two studies published in the Journal of the American Medical Association (JAMA) on September 12, 2007 found that use of Avandia (rosiglitazone) greatly increased the risk of heart attack and heart failure, and suggested that safer diabetes medications are available.
August 14, 2007: Avandia to Carry "Black Box" Warning
The U.S. Food and Drug Administration (FDA) announced that a number of diabetes drugs -- including Avandia (rosiglitazone) -- would now carry "black box" warnings on the risk of heart failure associated with use of the drugs. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients. The "black box" warning is FDA's strongest form of warning. FDA's review of Avandia and possible increased risk of heart attacks is ongoing.
July 30, 2007: Panel Makes Recommendations on Avandia
An FDA advisory committee recommended that diabetes medication Avandia (rosiglitazone) remain on the market despite evidence that use of the drug increases the risk of heart attacks. The panel advised the FDA that Avandia labeling should carry warnings of the increased risk of heart attack associated with the drug's use.
May 21, 2007: FDA Safety Alert on Avandia
The U.S. Food and Drug Administration (FDA) issued a safety alert on the diabetes drug Avandia (rosiglitazone), and its links to heart risks. The alert was issued shortly after a study published in the New England Journal of Medicine (NEJM) suggested a connection between use of Avandia and an increased risk of heart disease and heart attack. The NEJM article concluded that "patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone [Avandia] for type 2 diabetes."
If you have suffered an unfavorable reaction to Avandia, then you should speak with a Personal Injury attorney about taking legal action against those who are responsible. NationWide Law Group would be honored to assist you.
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