Category Archives: Overview of Avandia

Avandia Label Updated


Avandia Lawsuits Triggered due to Warning

GlaxoSmithKline PLC said it has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug’s links to heart attack.

 

The Food and Drug Administration announced the changes last September as the last in a series of safety actions against the former blockbuster drug, which has triggered thousands of patient lawsuits and a Department of Justice investigation. The European Union has banned the drug.

The new U.S. label indicates that Avandia is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market. Patients who are currently on the drug can continue taking it after consulting with their doctor.

While there are more than a dozen diabetes drugs on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia. U.S sales of Actos have risen steadily — hitting $3.4 billion in 2009 — as Avandia’s reputation has soured.

Avandia Sales Plummet

The FDA first approved Avandia in 1999 and it became the top-selling diabetes pill in the world, with more than $3 billion in sales by 2006. But use has plummeted since a 2007 analysis first linked the drug to heart attack.

Determining Avandia’s heart risk was a painstaking process that dragged on for years because most patients taking the drug are already predisposed to heart problems due to diabetes.

Have you Suffered any Side Effects from Avandia?

If you or a loved one has taken Avandia and has suffered any of the harmful side effects associated with Avandia, you may have a claim.  Please fill out the Free Case Review Form to the right and we will have an experienced Avandia Attoeny contact you to discuss your options.


Avandia


Avandia: Treatment for Type 2 Diabetes

Avandia, generic rosiglitazone maleate, is a drug to treat Type 2 diabetes and is manufactured by the UK-based pharmaceutical giant GlaxoSmithKline.  Type 2 diabetes is the most common form of diabetes, affecting about 18 million Americans. 

In Type 2 diabetes the body either does not produce enough insulin or does not use insulin properly. This results is high blood sugar levels that can cause problems such as kidney and eye damage. The Avandia claim is that it lowers blood sugar levels by increasing the sensitivity to insulin in peripheral tissue.

1 Million Americans have taken Avandia 

Avandia was the top-selling diabetes drug in the world and the second best seller for GSK, after its asthma drug Advair. It’s estimated that Avandia was taken by 1 million Americans in 2006 and generated $3 billion in sales.

Avandia was approved by the FDA (Food and Drug Administration) on May 15, 1999 for the treatment of diabetes. There was some controversy about the approval, but the FDA may have wanted to expedite the approval since problems had already arisen with the other diabetes drug then on the market, Pfizer’s Rezulin. Rezulin was removed from the market in 2000 because it caused sometimes fatal liver problems.

Avandia is part of a class of drugs known as PPAR agonists. These drugs activate or suppress dozens of genes, causing complex biologic effects. The effects differ from one PPAR agonist to another, depending on the genes affected.

Avandia in the News

Avandia hit the headlines on May 21, 2007 when a meta-analysis of 42 studies on the use of Avandia showed a significant increase in the risk of heart attack and other heart problems. 

The FDA eventually issued a warning about the study and required GSK to include a black box warning of cardiac side effects and to produce a new prescription guide that included these warnings. Critics claim the FDA should have acted sooner. The agency came under criticism and scrutiny for its handling of the Avandia approval and review.


What is Avandia?


About Avandia

Avandia is a prescription medication used with diet and exercise was created by GlaxoSmithKline to treat type 2 (“adult-onset” or “non-insulin dependent”) diabetes mellitus (“high blood sugar”).

Avandia may be used alone or with other anti-diabetic medicines. Active Ingredient: rosiglitazone maleate.  When Avandia was first approved it was intended to replace the recalled diabetes drug Rezulin as a safe alternative. Pharmacological studies in animal models indicate that rosiglitazone improves sensitivity to insulin in muscle and adipose tissue.

Type 2 Diabetes:  When a person does not make enough insulin or does not respond normally to the insulin their body makes this is considered type 2 diabetes. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, heart disease, loss of limbs, and blindness.

Avandia Side Effects

Avandia, Has many painful side effects when taken.  The most life-threatening side effect is congestive heart failure.

Heart failure symptoms include:

  • Chest pain
  • Swelling of the extremities
  • Weight fluctuations
  • Difficulty breathing/Shortness of breath

If you have heart failure, fluid retention, or active liver disease your healthcare provider will evaluate you to decide if Avandia is right for you.  

If you or someone close to you has suffered a heart attack or cardiovascular problems after taking Avandia, you may have the right to investigate the possibility that the injury was caused by Avandia.

Do you have an Avandia Claim?

If you feel you may have an Avandia Claim, please fill out the Free Case Review Form on the right and we will have an experienced Avandia Attorney contact you.



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