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Last updated January 5, 2009

AVANDIA INJURIES AND WARNINGS

Diabetes drug rosiglitazone (Avandia, Avandamet and Avandaryl) linked to:

  • Heart attacks and congestive heart failure
  • Liver failure
  • Bone fractures in women
  • Vision loss (macular edema)
  • Death (cardiovascular)

Black box warnings added to rosiglitazone labels.

The Law Offices of Howard L. Nations is filing Avandia lawsuits.

AVANDIA INJURIES

Avandia has been linked to an increased risk of serious and potentially fatal injuries, including heart attacks, congestive heart failure, liver failure, bone fractures in females, vision loss, and heart-related deaths.

Avandia is in a class of antidiabetic medications called thiazolidinediones (TZDs). These drugs can cause significant fluid retention thereby increasing the risk of heart failure by around 70%. The first TZD sold in the U.S., Rezulin, was taken off the market because it caused liver toxicity resulting in dozens of deaths.

Recent studies have shown an increased risk of heart attacks and heart-related deaths associated with Avandia use. These health risks do not appear to be linked to the other diabetes medications.

AVANDIA RESEARCH AND WARNINGS

Recently published studies have cast doubt on the safety of Avandia. Some of those studies and the FDA warnings are listed below:

December 2005: GSK sent out a Dear Health Care Provider letter to warn doctors about post-marketing reports of macular edema in patients taking rosiglitazone. Macular edema is a swelling of the retina causing visual loss and blurring.

January 5, 2006: The FDA issued a Safety Alert about the risk of macular edema from rosiglitazone (Avandia) use.

June 16, 2006: A warning about the risk of macular edema was added to the Avandia label.

February 20, 2007: Results of the ADOPT study showed that women with Type 2 diabetes mellitus who took rosiglitazone (Avandia) or Actos experienced more fractures of the upper arm, hand, or foot than those who took the older diabetes medications.

The FDA issued a Safety Alert about the study results and warned doctors to "consider the risk." GSK sent out a Dear Health Care Provider letter including the following statement:

Presently, our understanding of the clinical significance of the findings from these two long term trials is incomplete, and the mechanism(s) for the observed increase in fractures is uncertain. Further evaluation of these observations is ongoing.

May 21, 2007: The New England Journal of Medicine published study results showing that patients taking Avandia had a 30-40% greater risk of heart attack and an increased risk of heart-related death compared to those taking placebos or other antidiabetic medications. The researchers, who conducted an analysis of 42 published studies and clinical trials, concluded that there is an urgent need to clarify the cardiovascular risks of Avandia and, until then, patients and providers should carefully consider the risks before using it.

An FDA Press Release and Safety Alert discussed these study results, noting that other studies have yielded contradictory results and that no causal relationship had yet been established. They suggested that patients consult with their doctors about the health risks of rosiglitazone as the FDA continued their investigations.

August 14, 2007: The FDA ordered the following black box warning be added to the Avandia label to warn about the risk of congestive heart failure.

WARNING: CONGESTIVE HEART FAILURE

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients ... After initiation of AVANDIA, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDIA must be considered.

AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated....

In the FDA's Information for Healthcare Professionals, the FDA advised that doctors should factor in this new information as they evaluate treatment options for their diabetic patients.  The agency planned to continue their investigation into the medical complications and health risks of Avandia.

November 14, 2007: The FDA ordered that the following statement be added to the black box warning on the Avandia label to discuss the May 2007 heart attack study results:

WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA

A meta analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared AVANDIA to placebo, showed AVANDIA to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 total patients), comparing AVANDIA to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

In the FDA Press Release, doctors were advised to closely monitor their Avandia patients for cardiovascular risks.  Meanwhile, the FDA would continue to evaluate the medical complications and health risks of the diabetes drugs containing rosiglitazone (Avandia, Avandaryl & Avandamet). 

November 24, 2008: Study results show that elderly diabetic patients taking rosiglitazone (Avandia) were 13% more likely to develop congestive heart failure and 15% more likely to die than those taking pioglitazone (Actos).

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HELP FROM AVANDIA LAWYERS

Since Avandia first entered the market 9 years ago, there has been a steady influx of evidence regarding its dangerous side effects. GSK has responded by minimizing researchers' conclusions and seeking contradictory results. The FDA has responded with warnings and continued investigations. Meanwhile, diabetic patients continue to take Avandia and related diabetes medicines Avandamet and Avandaryl, often completely unaware of the serious health risks and dangers to which they are exposed.

If you or someone you know has suffered congestive heart failure, heart attack, bone fractures, liver failure, macular edema, or death as a result of taking the diabetes drug rosiglitazone (Avandia, Avandamet, or Avandaryl), contact our offices for a free case evaluation by one of our experienced pharmaceutical attorneys.