In
2001 GlaxoSmithKline, the makers of the diabetes medicine Avandia received a
warning letter from the U.S. Food and Drug Administration. The letter urged the
company to be clear in its warnings about possible risks associated with taking
Avandia, such risks include Avandia-induced heart attacks, Avandia-related cardiac
disease and congestive heart failure caused by Avandia.
The combination of Avandia
and insulin can result in a condition called fluid-overload disease, which may
lead to cardiac arrest
and death.
Two
Diabetes Drugs to Display Strongest Warning
The Food and Drug Administration is calling for the makers of Avandia and
Actos to carry the most prominent safety warning to alert doctors and patients
of potential heart risks. The call for a stronger warning comes more than a year
after FDA safety reviewers recommended such steps. The agency made the announcement
as officials were questioned as part of a Congressional investigation regarding
the delayed warning of heart risks associated with Avandia. Gardiner Harris,
The New York Times 06/07/2007 Read Article: The
New York Times
Drug
Maker Threatened Lawsuit against Critic, A medical expert told lawmakers Wednesday
that GlaxoSmithKline executives threatened him with a lawsuit after he drew attention
to potential dangers of Avandia in 1999. John Buse, head of endocrinology at
the University of North Carolina, told members of Congress that after he raised
concerns about potential heart problems associated with Avandia, executives said
they intended to hold him responsible for a $4 billion drop in company stock. Matthew
Perrone, Forbes 06/06/2007
Avandia Maker Sued Over Heart Attack
“The widow and son of a Beaumont man are suing the maker of the popular
diabetes drug Avandia, alleging it contributed to the man's death from a heart
attack. Larry Alan Stanford, 60, died May 21, the same day a scientific analysis
was published in the New England Journal of Medicine saying that Avandia was
linked to a greater risk of heart attack and possibly death. His widow, Peggie
Stanford, and son, Ryan Stanford, filed the lawsuit against GlaxoSmithKline PLC
on Tuesday in U.S. District Court for the Eastern District of Texas.”
Associated Press, Forbes 6/20/07
Diabetes
Drugs to Receive Strongest Warning
The makers of diabetes drugs Avandia and Actos have agreed to add the most severe
warning to inform patients that the medications may increase the risk of heart
failure. The Food and Drug Administration said the so called “black box” warnings
are separate from concerns that Avandia may increase the risk of heart attacks.
A separate FDA review of Avandia and Actos side effects showed cases of significant
weight gain and build up of fluids, both risk factors for heat failure. AP,
The Washington Post 08/16/2007
Experts called study done by Avandia inconclusive at best and a sign of greater
risk at worst...
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more.
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