Since Avandia® was approved in 1999, the Food and Drug Administration (FDA) has been monitoring its link to severe side effects. In May of 2007, researchers announced that Avandia users may be at a serious risk of heart attack. The risk of a heart attack was increased 43% among those taking Avandia. There may be up to a 64% increased risk of dying from cardiovascular causes while taking Avandia.
Authors noted their numbers were not conclusive, and could be attributed to other factors. They stated that there is a “considerable uncertainty about the magnitude of the observed hazard.”
However, in July of 2010, an FDA panel said there are “significant safety concerns” that Avandia raises the risk of heart attack and chest pain.
Avandia Food and Drug Administration Warning
The FDA issued the following warning regarding Avandia’s risks:
“This Alert highlights important revisions to the full prescribing information for rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl). The updated information includes a new BOXED WARNING, and additional updated WARNINGS, PRECAUTIONS, and CONTRAINDICATIONS to emphasize that rosiglitazone may cause or exacerbate heart failure, particularly in certain patient populations.”
Avandia Warning Label
Avandia’s warning label cautions users of the following:
“Avandia can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on Avandia. Avandia is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe.
Avandia may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.
If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take Avandia, tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.”
What should I do if I took Avandia?
If you or someone you love took or is taking Avandia and has suffered serious cardiovascular problems, contact our law firm immediately for a free and confidential case evaluation.
Do not discontinue taking any medications without first consulting your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.
Author Resource:
Byron Fanning is the author of this article on Avandia Lawsuit Attorney .
Find more information about Attorney For Avandia here.
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