Have our congressional representatives proposed any new laws or regulations regarding the safety of Avendia?
Yes. Senator Chuck Grassley and Representative Rosa DeLauro led a bipartisan oversight committe regarding the safety of Avandia. After the Journal of the American Medical Association's (JAMA) June 2010 reports regarding the diabetes drug Avandia, the members of Congress issued the following statements regarding the safety of Avandia:
Senator Chuck Grassley: “The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July. Patients and taxpayers need and deserve a clear response and rationale from the Food and Drug Administration about the safety and efficacy of this drug."
Representative Rosa DeLauro: “Coupled with the previous findings, these new studies appear to confirm that Avandia is dangerous and should be pulled from the market. The evidence now seems to be overwhelming that taking Avandia significantly increases a patients’ risk of a heart attack, even when compared to a similar prescription drug. This information will make it even more difficult for the FDA to justify keeping this dangerous drug on the market.”
Previously, in February 2010, Grassley and Chairman Max Baucus expressed concern about regarding whether the FDA had taken appropriate actions to protect patients from dangers associated with taking Avandia. Notably, the congressional committee raised concerns about whether the Avandia manufacturer (GlaxoSmmithKline) was aware of heart attack risks associated with the Avandia, whether the company sufficiently warned patients and the FDA of the dangers, and whether the company attempted to create doubt regarding negative findings about the drug. If If
If the FDA's concerns are correct, GlaxoSmithKline may face legal troubles under product liability laws.
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 issued any safety alerts regarding Avandia?
A: 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 … 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:
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 -
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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
