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Drug News--disappointing

FDA asleep at the wheel, failure to respond to evidence of side effects.  An estimated 200,000 people world-wide have died early from taking this drug rather than a safer and more effective alternatives.  The same is true of its sister Actos (pioglitazone).  These diabetes drugs cause liver damage, weight gain, anemia, macular degeneration, bone fractures in women, and heart failure.  


From about.com


What is the Safety History of Avandia (rosiglitizone)?

Debra Manzella, R.N., her Diabetes Blog. 


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".

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.

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.

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.

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.

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.

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.

Wednesday May 23, 2007







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Those who have a financial interest in the outcome manipulate the results