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Avandia/Actos Lawsuit

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Avandia (rosiglitazone) Update - Boxed Warning For Heart Attacks Added To Anti-Diabetes Drug Prescribing Information

Avandia and Actos

The U.S. Food and Drug Administration (FDA) recently announced that its strongest type of warning-a "Black Box" warning-will be placed on Type 2 diabetes drugs Avandia (rosiglitazone) and Actos (pioglitazone) due to the potentially increased risk of heart attack and heart-related deaths in patients taking Avandia or Actos. Avandia is manufactured by GlaxoSmithKline, while Actos is manufactured by Takeda Pharmaceuticals, and both also manufacture similar drugs which also fall within the warning (GSK - Avandaryl, Avandamet; Takeda - Duetact). If you have been prescribed or are taking Avandia or Actos, or one of the similar drugs, you may be at risk.

Type 2 diabetes is a serious and life-threatening disease which affects about 18-20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation.

The strengthened warning advises health care professionals to be vigilant in checking for signs of heart failure in their Type 2 patients taking these Avandia, Actos, or similar drugs, such as excessive, rapid weight gain; shortness of breath; and swelling (edema) of the extremities or organs. Patients taking Avandia, Actos, or a similar drug, who notice these symptoms, or who have underlying heart disease or who are at high risk of heart attack, should contact their doctor immediately. Type 2 diabetes patients taking Avandia, Actos, or a similar drug, are advised not to stop taking the drug on their own, only if directed by their doctor.

Avandia received FDA approval in 1999. Since its approval of Avandia, 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 post-marketing reports. Prior to the recent "Black Box" warning, the FDA had updated the product's labeling on several occasions to reflect new data. The most recent labeling change for Avandia, in May 2007, also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

Earlier this year, the manufacturer of Avandia (GlaxoSmithKline) provided FDA with a pooled analysis of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. This data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.

Since the most recent labeling change, Actos and similar drugs have been included in the warnings. Further, at least one other pooled-data analysis conducted by the Lahey Medical Center in Massachusetts, confirmed the dangers posed by Avandia, Actos, and similar drugs, in increasing Type 2 diabetes patients' risk of heart failure.

If you or a loved one have been prescribed or have taken Avandia, Actos, or one of their similar drugs (Avandaryl, Avandamet, Duetact) and have suffered a Heart Attack, Stroke or Heart Damage, you need to contact a law firm with the experience to take on the big Drug Companies.

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