What is the Safety History of Avandia (rosiglitizone)?

Rosiglitazone (classification: thiazolidinedione (TZD) was approved by the Food and Drug Administration (FDA) in 1999. In a FDA "Talk Paper" Rosiglitazone is announced as approved and that precautions should be taken by people who take rosiglitazone, and that they should be monitored for evidence of liver toxicity while taking the drug. This warning followed on the heels of a drug recall of Rezulin (troglitazone) another TZD drug that caused liver failure and death. There is no mention of congestive heart failure or other adverse cardiovascular concerns. FDA "Talk Papers" are generated by the FDA press office as a guide for FDA personnel to enable them to respond with "consistency and accuracy to questions from the public".

• FDA Talk Paper - FDA Approves Rosiglitazone to Treat Type II Diabetes

On June 28th, 2001, the FDA sent a warning letter to GlaxoSmithKline stating that they were minimizing the risks of Avandia in their promotional materials. The FDA requested that GSK discontinue distribution of the misleading informational materials and adhere to the bolded warnings about the heart-related side effects of Avandia as agreed upon.

• Letter from the FDA to GlaxoSmithKline regarding misleading promotional materials

In April of 2002, The FDA issued a letter to healthcare professionals alerting them to a change in the warning label on Avandia and Actos to include the possibility of excess fluid retention and congestive heart failure in patients who were prescribed these drugs.

• FDA letter to healthcare professionals regarding warning label changes for Actos and Avandia

A letter from the FDA to GSK in December of 2002, asks GSK to revise the warning label for Avandia to include this paragraph:

"In postmarketing experience, there have been rare reports of unusually rapid increases in weight and increases in excess of that generally observed in clinical trials. Patients who experience such increases should be assessed for fluid accumulation and volume-related events such as excessive edema and congestive heart failure."

This letter indicates the growing body of evidence that Avandia caused congestive heart failure and related cardiac problems in some people.

• Letter from the FDA to GSK recommending a warning label change

In 2006, a "prescribing information" paper issued for Avandia from FDA's MedWatch talks about the increasing evidence of risk of cardiovascular events. This is found on page 13 of the document and highlighted in yellow by MedWatch. MedWatch is the FDA Safety Information and Adverse Event Reporting Program.

• Prescribing Information for Avandia from FDA's MedWatch

The longer Avandia and Actos have been on the market, the more evidence of adverse cardiac events, fluid retention and congestive heart failure. All of this culminated this week with the newest study on Avandia which linked it to a risk of heart attacks and death from cardiovascular events.

• Avandia May Cause Risk of Heart Attack and Death - from your Diabetes Guide
• Avandia Linked to Increased Heart Attacks - from Dr. Rich Fogoros - Your Heart Disease Guide

People who take Avandia or Actos are encouraged to call their doctors for advice on switching their diabetes medication to a class of drug that does not cause cardiac side effects.