foodconsumer.org: Diabetes drug Avandia may raise risk of heart attacks and stroke

Diabetes drug Avandia may raise risk of heart attacks and stroke
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admin on 02/21/2010 22:38:00
 
One Senate committee on Friday released a report saying that GlaxoSmithKiline
has known for several years that its diabetes drug Avandia is tied to
significantly increased risk of heart attack among patients and the drug maker
failed to warm patients of the risk.
The committee staff made the conclusion after reviewing more than 250,000 pages
of documents provided by GlaxoSmithKline (GSK/the Company), the Food and Drug
Administration (FDA), the University of North Carolina, and others.
The association between Avandia and increased risk of cardiac events is not
news.  Numerous studies have pointed to one thing that the drug increases the
risk of cardiovascular events among the diabetes patients.
For example, one study in the Sept 2009 issue of P & T : a peer-reviewed journal
for formulary management shows that Avandia known as rosiglitazone maleate was
linked to significantly increased risk of acute myocardial infarction (heart
attack) and stroke.
Shaya FT and colleagues conducted the study to see if there is any difference in
the risk of acute MI, hemorrhagic and non-hemorrhagic stroke between different
thiazolidinediones or TZDs. Specifically, they compared avandia to pioglitazone
or Actos.
Based on retrospective medical encounter and prescription data, the authored
concluded that risoglitazone compared with other diabetes drugs was associated
with a 20 percent increased risk of cardiovascular events in diabetic patients.
On the other hand, the researchers did not find any association between Actos -
another diabetes drug manufactured and marketed by Takeda Pharmaceuticals North
America, and increased risk of heart attack and stroke.
Many studies have shown diabetes patients who used Avandia were at much higher
risk of heart attack and heart failure compared to those on other diabetes
medications.
One such study was conducted by Sonal Singh, M.D. at the Wake Forest University
School of Medicine in Winston Salem, NC and colleagues and released in the Sept
12th 2007 issue of the Journal of American Medical Association.
The researchers analysed data from four randomized trials of 14,291 type 2
diabetes patients, who were followed one to four years and found patients on
Avandia were 42 percent more likely than controls to suffer heart attack.
Dr. Singh in 2007 published a comment on news.google.com suggesting that "every
220 diabetic patients treated with Avandia(r) for one year, one will have an
additional heart attack linked to the drug. There would be one additional case
of heart failure for every 30 people taking the drug for one year."
"The public health impact of these harms among millions of Avandia(r) users in
the United States is substantial (conservative estimate of at least 4000 excess
MIs and 9,000 excess heart failure events linked to Avandia(r) each year),"
Singh added.
It appears that the Food and Drug Administration started paying attention to the
safety issue of Avandia in 2007 when it issued safety alerts a few times that
avandia may cause or exacerbate heart failure.
The FDA should have banned Avandia, Dr. David Graham, a scientist at FDA, and
Dr. Sidney Wolfe of Public Citizen told the FDA advisory panel.  The drug should
have been withdrawn quickly not only because it poses a serious danger to
diabetes patients, but also because another similar drug that can be used but is
much safer.
The risk of heart failure associated with Avandia was 15.2 times higher compared
to an old diabetes drug Glucotrol, reported Consumer Affairs.com citing Wolfe's
testimony. The risk of liver toxicity associated with Avandia was 9.5 times
higher and liver failure risk was 14.8 times higher in dietetics who used
Avandia.  Dr. Graham, who is the FDA's veteran drug safety reviewer, said
withdrawal of Avandia could save thousands of lives each year.
But media reports say that the FDA advisory committee rejected the
recommendations by Drs. Grham and Wolfe, believing that the diabetes drug
Avandia should remain on the market.
A health observer suggests that diabetes patients who believe that they need
medications to control their condition should talk to their physicians about use
of Actos instead of Avandia. If their doctors insist on their using Avandia,
they may try other physicians.
Those who believe diabetes can be improved by a modified lifestyle may follow a
diabetic friendly diet.  Many studies have suggested that some foods are more
helpful than others.
By Jimmy Downs
Senate report links diabetes drug Avandia to heart attacks