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
