FDA Issues Strictest Warning on Prescription Diabetes Drug Avandia
On June 6, 2007, the Food and Drug Administration (FDA) called for the most
stringent warning to be added to prescription Type 2 diabetes drug
Avandia.
The decision was revealed before a packed Congressional House
hearing. It comes, however, more than a year after FDA safety reviewers strongly
recommended that the agency take such a step.
In effect, the decision
tells GlaxoSmithKline, manufacturer of Avandia, to make the warning about
Avandia's heart risks more prominent, by placing it in a so-called "black box."
According to the New York Times, the call for this heightened
warning is due to the fact that "despite existing warnings, these drugs
[[diabetes drugs Avandia and Actos, the latter made by Eli Lilly]] were being
prescribed to patients with significant heart failure."
The article
quotes Representative Henry Waxman, a California Democrat who is chairman of the
House Committee on Oversight and Government Reform as saying, "Avandia is a case
study of the need for reform of our drug safety laws."
If you or a loved
one has suffered cardiac complications after ingesting Avandia, you deserve the
guidance of an experienced drug attorney. Get a free case review by filling out
the form below.
see also:
Study Reveals Risks, 6.6.07
Study Designed to Debunk Risks Raises Questions About Avandia MedicineAvandia Medicine Still Has Serious Heart Risks, Doctors Warn
FDA Safety Information
FDA Releases New Safety Info on Diabetes Drug Avandia and Side EffectsFDA Updates Public on Safety Information for Avandia and Side Effects
News & Warnings
Avandia Breaking News: Glaxo Warned in 2001 about Misleading MarketingBloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001
