Avandia Questions

Q) Does Avandia increase the risk of a heart attack only when taking the drug or does the increased risk remain after you stop taking the drug (examples of other drugs would include: Vioxx – increased risk of heart attack stopped when you quit taking the drug, versus Phenfen – apparently resulted in permanent heart valve damage, thus increase in risk continued)?

A) First of all, the increased risk is not proven; it’s only the conclusion of a meta-analysis that was published today. As the FDA said: "FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies." By the nature of the data source (mostly clinical trials that study the drug, not what happens after the drug is stopped), there’s no available information about whether the risk persists after discontinuing Avandia.

Q) The FDA bulletin reported that the pooled analysis indicated that "short-term" treatment (defined as 6 months) suggested an increase of 30-40 percent for risk of a heart attack. What if you have taken Avandia for a longer period of time (in the past or still currently using)?

A) The authors of the NEJM article mention that "Time-to-event data for cardiovascular events were not available in any of these trials" – hence the effect of duration of treatment (if any) is unclear from the present meta-analysis. Most studies in the meta-analysis were 6 months’ duration – in fact the authors deliberately excluded studies of short duration: "Criteria for inclusion in our meta-analysis included a study duration of more than 24 weeks…".

Q) Has there been any preliminary identification of testing that may be able to indicate potential damage or increased risk conditions?

A) FDA answered this one best: "Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes."

Q) I've been on Avandamet [Avandia and metformin in a combination tablet] for over 2 years. I'm also concerned about the identified risk factors of Avandia. Is there any change to the risks if you take it with metformin?

A) The meta-analysis did look at studies of patients taking both Avandia and metformin, but there’s no discussion whether the risk changed in patients taking both compared to patients taking only Avandia.

And the most important question of all for patients taking Avandia:

Q) Should I stop taking my Avandia?

A) No! As mentioned above, patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

And when you go to your physician, bring along the reprint of the FDA Safety Alert, which I reproduce below: