****** MEDICAL ALERT: FDA issues WARNING as Avandia could be the new Vioxx! *****
If you, or someone you know, is taking the diabetes drug Avandia (rosiglitazone), a drug made by GlaxoSmithKline, please tell them to IMMEDIATELY seek medical advise with a view to possibly stopping the use of the medication. The drug, like Vioxx before it, which was voluntarily withdrawn from the market by its manufacturer, Merck, after the drug was implicated in increased risks of heart attacks and strokes in users, has been linked to HUGELY increased risk of heart attacks in users and the FDA (the Food and Drug Administration) has just issued a SAFETY ALERT on it.
Here is an excerpt from the ALERT:
Avandia was approved in 1999 for treatment of type 2 diabetes ... . 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.
...
Recently, ... 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. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.
Here is an excerpt from the ALERT:
Avandia was approved in 1999 for treatment of type 2 diabetes ... . 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.
...
Recently, ... 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. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.
Labels: Capitalism, Public health, Public safety
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