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Avandia® Warning PDF Print E-mail

As a result of serious and potentially life-threatening side-effects that have been reported in patients prescribed GlaxoSmithKline's (GSK) oral diabetes-managing drug, Avandia®, warnings have been issued to alert patients and medical officials to the problems that the drug may pose.

Avandia® And Side Effect Warnings

Designed to stabilize and regulate the blood-sugar levels of patients diagnosed with Type-2 (non-insulin-dependent) diabetes, Avandia® has been shown to have a number of serious side-effects, including:

  • Death
  • Heart Attack
  • Heart Failure
  • Stroke
  • Bone Fracture

In May 2007, the Food and Drug Administration (FDA) issued a warning that described the potentially-serious side-effects associated with Avandia® usage, which included an increase in the risk of heart-attack by 43-per-cent and heart-disease by 64-per-cent.

The FDA's Avandia® Warning

According to the FDA's warning:

Avandia® was approved in 1999 for treatment of Type-2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans.

Diabetes is a leading cause of coronary heart disease, blindness, kidney-failure, and limb amputation.

The FDA continued:

"Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia® alone and in combination with other drugs, and from post-marketing reports.

"FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006."

The FDA concluded:

"The most recent labeling change for Avandia® also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia®.

"This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure."

How DrugRxRecall Can Help You With Avandia® Warnings

If you have any questions about the FDA's warnings concerning Avandia®, do not hesitate to contact us immediately.

And if you have suffered from any of the above side-effects after taking Avandia®, you may have a claim for compensation.

Here at DrugRxRecall, we work closely with highly respected lawyers.

We will be pleased to refer you to reputable and experienced lawyers in your area who can offer you a free consultation, and answer your questions about FDA warnings, legal issues, and potential grounds for lawsuits.


 
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