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:
Avandia Diabetes Pills
Glaxo Failed to Disclose Studies Regarding Avandia Diabetes PillsFDA wasn't told about safety reports on Avandia Pills--lawsuit info
Veterans Affairs: Avandia
Veterans Affairs Severely Limits Use of GlaxoSmithKline's Avandia DrugVeterans Affairs Limits Use of Glaxo's Avandia Due to Safety Concerns
News & Warnings
Avandia Breaking News: Glaxo Warned in 2001 about Misleading MarketingBloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001


