Avandia®, or rosiglitazone, is a drug used by millions of Americans to treat diabetes. Avandia is specifically used to treat type II diabetes mellitus (non-insulin-dependent, “age-onset” diabetes) by combating insulin resistance.
In May of 2007, however, researchers announced that Avandia users may be at serious risk of heart attack and cardiovascular disease. Their results are based off a meta analysis, which the authors themselves claimed are not meant to be conclusive and have certain limitations. Their results showed the risk of heart attack was increased 43% among those taking Avandia, and a risk of dying from cardiovascular causes in patients taking Avandia was increased 64% (1). The researchers also noted that they can’t yet tell if there is an association between Avandia and heart attacks or Avandia and heart disease in general (3).
Doctors from the Institute for Clinical Evaluative Sciences in Toronto analyzed the data for 159,026 adults who were treated with at least one diabetes drug (such as Avandia) between 2002 and 2005. The study was reported in the Journal of the American Medical Association.
The results of their study were frightening for Avandia users: 7.9% of patients were hospitalized for congestive heart failure, 7.9% were hospitalized for heart attack, and 19% of the patients died after taking diabetes drugs.
Thiazolidinediones, the class of drugs which were studied and which Avandia belongs to, are thought to increase the risk of heart failure, heart attack, and death by 60%, 40%, and 29% compared to other oral diabetes drugs.
The authors of the study write, "These findings provide evidence from a real-world setting and support data from clinical trials that the harms of thiazolidinediones may outweigh their benefits, even in patients without obvious...cardiovascular disease."
Source: “Avandia heart risks seen at the population level.” Published on 12/11/07, accessed 12/11/07 via www.reuters.com.
FDA ALERT [8/2007]: 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.
Type II diabetes can cause any number of complications if not well managed, including heart disease, stroke, kidney disease, nerve damage, and blindness.
In May of 2007, researchers announced that Avandia users may be at a serious risk of heart attack and drug injury. 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 (1) (2). The study's authors, however, noted that these numbers are not conclusive, and could be attributed to other factors. They stated that there is a "considerable uncertainty about the magnitude of the observed hazard."
Never stop taking any medication without first consulting your doctor. The FDA reports that Avandia may cause serious health problems and drug injuries. If you or someone you love took or is taking Avandia and has suffered a heart attack, contact our drug injury attorneys immediately for a free and confidential case evaluation.
Source:
1) “Avandia: Getting the Facts,” by Maria Esposito of Fox News. Accessed 5/22/07 via www.FoxNews.com.
2) "Effect of Rasiglitazone in the risk of myocardial infarction or death from cardiovascular causes," NISSEN, etal, NEJM 2007; 356 (24): 2457-71.
3) "Avandia Heart Disease Debate Continues," by Miranda Hitti of WebMD Medical News. Accessed 7/06/07 via www.WebMD.com.
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.
Avandia® is a registered trademark of GlaxoSmithKline. The reference to the registered trademark of GlaxoSmithKline is used here only for the purpose of identifying the product in question.
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