Pharmaceutical Drug Injury: Avandia

Avandia®


Heart attack :: Stroke :: Bone Fracture

Avandia (generic name rosiglitazone) (Avandamet and Avandaryl) was introduced in 1999 by GlaxoSmithKline.

Avandia® may possibly be linked to a variety of serious side effects, including liver failure, cardiovascular problems (heart failure), stroke (ischemic) , edema and bone fractures.

Avandia® is a widely prescribed drug used to treat Type II diabetes, and has been shown in studies to increase users' risk of heart attack by 43 percent and cardiac-related events by 64 percent, according to researchers. Approximately 20 million Americans are diagnosed with Type II diabetes (also called adult onset or non-insulin dependent).

If you have Type II diabetes and have been prescribed and taken Avandia®, it is very important to watch for signs of heart failure after beginning Avandia® or increasing your dosage, and patients should be carefully monitored for signs and symptoms of cardiovascular problems, including heart failure. Some of the symptoms or problems associated with Avandia may include:

  • congestive heart failure
  • heart attack
  • stroke
  • allergic reaction
  • Edema (swelling)
  • Shortness of breath (dyspnea)
  • bone fracture

A recent article in Forbes - "Avandia Raises Risk of Heart Failure, Fractures" - about the RECORD study states that "The diabetes drug Avandia significantly raises the risk of both heart failure and bone fractures, but it does not boost the odds for either cardiovascular disease or death, new research has found."

In addition, a recent article by Reuters - "Research: Popular Diabetes Medications Associated with Increase in Bone Fractures" - about the Medco and University of Texas study states that "Thiazolidinediones Increase Risk of Fracture - A study by researchers from Medco and the University of Texas Health Sciences Center found that patients with type 2 diabetes taking a thiazolidinedione (TZD) to help control their blood sugar experienced a 43 percent higher incidence of bone fracture than type 2 diabetes patients not taking TZDs. TZDs -- a class of drugs used to control blood sugar -- are used by as many as 4 million Americans."

Other Avandia Side Effects

Avandia® patients should stop taking the drug immediately and contact their physician if they experience any of the following conditions:

  • Swollen legs or ankles
  • Rapid, unexplained weight gain
  • Shortness of breath or difficulty breathing
  • Tiredness
  • Chest pains
  • Confusion
  • Stomach pain
  • Skin rashes or hives
  • Jaundice
  • Nausea

Major Medical Clinic Releases Study

The New England Journal of Medicine released an article of a study that was conducted by two doctors at the Cleveland Clinic in June 2007 who evaluated 42 studies that compared patients taking Avandia® with those who were not. The overall study involved 28,000 patients, 15,560 of whom were taking Avandia®.

Of those patients taking Avandia®, 86 suffered heart attacks compared to 72 among patients not on the drug. In addition, another 39 patients died from cardiovascular causes compared to 22 patients who were not taking Avandia®.

Food & Drug Administration Action

In May 2007, the FDA finally approved a black box warning - the agency's strictest safety notice - for Avandia® about its link to heart attacks.

The new warning said that patients with the most severe forms of heart failure should not take the drug, and that thiazolidinediones are not recommended for patients with heart failure that causes symptoms.

The warnings also advise that doctors should reconsider the use of drugs like Avandia® if a patient develops heart failure while taking thiazolidinediones.

Other Possible Medical Problems From Avandia

The Gooch Law Firm is also investigating reports of Avandia-related bone fractures in many patients.


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