Drug Injury

Avandia®

What is Avandia®?

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.

Avandia Update:

In July of 2010, a Food and Drug Administration (FDA) advisory panel reviewed scientific data and information on Avandia after serious concerns were raised about the drug's safety. The 33-member panel voted 18-6 and said there are "significant safety concerns" that Avandia raises the risk of heart attack and chest pain. The FDA then ordered the manufacturer of Avandia to stop enrolling new patients in a new clinical trial to assess the health risks posed by the drug, because it is "unethical to expose patients to risks that have been shown statistically to be quite real."

Three years ago, a major study revealed the blockbuster diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry and questions about the drug's safety. In May of 2007 researchers announced that Avandia users may be at serious risk of heart attack and cardiovascular disease. Their results were 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 64% increased risk of dying from cardiovascular causes in patients taking Avandia (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).

Study shows Avandia heart risks

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.

What is type II diabetes?

According to the Centers for Disease Control and Prevention, type II diabetes affects over 15 million Americans and makes up 90 to 95% of all diabetes cases. Often called a “silent killer” because of its tendency to go undetected until one or more of its adverse effects surfaces, type II diabetes is characterized by abnormally high blood sugar levels caused by the body’s low insulin production and/or its inability to use the insulin already produced (called insulin resistance).

Type II diabetes can cause any number of complications if not well managed including heart disease, stroke, kidney disease, nerve damage, and blindness.

Why is Avandia potentially dangerous?

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 (1) (2). The study 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." In July of 2010, an FDA panel said there are "significant safety concerns" that Avandia raises the risk of heart attack and chest pain. 

What should I do if I took Avandia?

Never stop taking any medication without first consulting your doctor. The FDA reports that Avandia may cause serious health problems. If you or someone you love took or is taking Avandia and has suffered a heart attack, contact our law firm immediately for a free and confidential case evaluation.

Sources:

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.

This  law firm is not affiliated with, sponsored by, or associated with GlaxoSmithKline, Fox News, the Food and Drug Administration, WebMD, or Reuters.

© 2006 Woods and Woods Evansville, Indiana Injury Lawyers.
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