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FDA Gave Glaxo Extra Year to Profit Off Avandia
By Evelyn Pringle (about the author) Page 2 of 2 page(s)
In addition, according to the FDA web site, significantly more female patients who received Avandia in the ADOPT study, "experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide."
In an all too familiar pattern with the Bush-controlled industry friendly FDA, Americans were kept in the dark about the risks associated with a drug in what many experts are calling another Vioxx-like disaster.
On May 23, 2007, Reuter's reported that Europe's watchdog, the European Medicines Agency (EMEA), had taken action on the risks of Avandia last year by strengthening the warnings on the drug.
"The situation in Europe is a little bit different to the American situation because," the agency spokeswoman said, "in Europe, Avandia is contraindicated in patients with heart failure anyway and we have warnings about ischemia."
She also referred to a May 2007 study in the New England Journal of Medicine, conducted by Cleveland Clinic cardiologist Dr Steven Nissen, which found Avandia to be associated with a 43% increase in heart attacks and possibly a 64% increase in cardiovascular death. The EMEA spokeswoman explained that "the majority of the studies looked at in the Nissen paper have already been assessed by the (the agency's expert) committee and, partly due to that, the SPC (summary of product characteristics) was updated in 2006."
Only after being boxed in a corner, on June 6, 2007, the Johnny-come-lately, FDA Commissioner von Eschenbach, informed a US House Committee that the FDA is now requesting that a black box warning about CHF be added to the labels of Avandia and another diabetes drug Actos.
However, an extra year with a sleeping US watchdog paid off well for Glaxo. According to a May 21, 2007 USA Today article, doctors in the US wrote 13 million prescriptions for Avandia last year, generating more than $2 billion in sales, according to figures from the data tracking firm IMS Health. Three million prescriptions had already been sold by the end of March 2007.
Persons seeking legal advice regarding Avandia can contact Baum, Hedlund, Aristei, Goldman & Menzies Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/
http://www.avandia-heart-lawyers.com/
Evelyn Pringle
evelyn-pringle@sbcglobal.net
(Written as part of a series on Avandia sponsored by Baum Hedlund's Pharmaceutical Litigation Department)
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