Tuesday, May 22, 2007

Avanaia (Diabetes Drug) and Claimed Link to Heart Attack Risk

From the upcoming NEJM comes a report that after an analysis of previous studies, patients on Avandia were reportedly more than forty percent likely to have a heart attack. The researchers also found a trend toward high death rates. Avandia is taken by 1 million Americans and generated sales of $3 billion in 2006. Source here.

The accompanying NEJM editorial hammered the drug's maker. While noting there were flaws in the study, “in view of the potential cardiovascular risks... the rationale for prescribing [Avandia] is unclear.”Assuming its findings are valid, they indicate “a major failure” of drug monitoring in the U.S., the editorial said. NEJM here.

I hope the impact of that clearly damning statement makes its way to Joe Citizen.

Congressmen John Dingell Bart Stupack have said they would launch an inquiry into what they called the failure of the manufacturer as well as the FDA to warn diabetics about possible risks associated with the drug.

The FDA's newly issued safety alert states:

“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,”

The quote can be found in an article in the Congressional Quarterly with the title "FDA Under Fire for Handling of Diabetes Drug Risks." Here.

Can it get any worse for the FDA? My best is yes. It has not yet hit rock bottom.