Has the FDA issued any safety alerts regarding Avandia?
By: LawInfo
Yes. The FDA has issued safety alerts about the use, and side effects of using, Avandia. In addition, the FDA has conducted long investigations into its safety.
FDA ALERT #1: 5/21/2007, updated 11/19/2007: The FDA added a new warning about the risk of myocardial ischemia to the boxed warning for Avandia, for treatment of Type 2 Diabetes.
FDA ALERT #2: 8/14/2007: The FDA issued important revisions to the full prescribing information (labeling) highlighting increased risks of congestive heart failure associated with rosiglitazone.
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Additional Avandia FAQs
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Q:
What is Avandia?
A: AVANDIA is a prescription medicine used, along with diet and exercise, to treat adults with type 2 (“adultonset” or “non-insulin … More -
Q:
Is Avandia dangerous?
A: Taking Avandia may be dangerous. The FDA has warned that AVANDIA can cause serious side effects related to heart failure and other heart problems. … More -
Q:
Can Avandia cause heart failure?
A: Yes, it can causecongestive heart failure in some patients. The FDA specifically issued the following warnings: WARNING: CONGESTIVE HEART FAILURE … More -
Q:
Who should NOT take Avandia?
A: Many patients with heart failure should not start taking AVANDIA.In addition, if you have any of the following medical conditions, you should talk about them with … More -
Q:
Has the FDA conducted studies to determine the safety of taking Avandia?
A: Yes. In fact, the FDA had enough concern over whether the increased risk of heart failure linked to Avandia is even worth it being on the market at all. … More -
Q:
Have our congressional representatives proposed any new laws or regulations regarding the safety of Avendia?
A: Yes. Senator Chuck Grassley and Representative Rosa DeLauro led a bipartisan oversight committe regarding the safety of Avandia. After … More -
Q:
Do patients who've suffered harm from a dangerous drug have a right to bring a lawsuit or a class action lawsuit?
A: Absolutely. There have been many successful lawsuits, including class action lawsuits, brought by consumers after being harmed by a dangerous or recalled drug. … More -
Q:
What is 'strict liability'?
A: Some persons or companies may be held “strictly liable” for certain activities or products that harm others, even if it can’t be shown they acted … More -
Q:
What is a black box warning?
A: A black box warning, also referred to as a boxed warning, is the most urgent warning mandated by the FDA. It is used to alert consumers of the adverse risks … More
