May 21, 2007
FDA Issues Safety Alert on Avandia
Yet another drug has been elevated in it's "unsafeness." Remember that all drugs are toxic. The paradigm of supporting health through the administration of poisons is amazingly flawed. Some people may in fact need drugs like this in the short term, but wellness is a paradigm that focuses on giving the body what it needs and limiting access to what it doesn't.
One way of supporting wellness is through the appropriate use of dietary supplements to ensure adequate nutrient intake. Dietary supplements are intended to supplement, not substitute, the benefits of a good diet so don't forget to eat well too!
Avandia side effects can be serious, but if you're a diebetic the side effects of leaving your condition can be even more serious. Are you taking Avandia? Seek the advice of your medical professional before "dropping" Avandia or any medication.
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The U.S. Food and Drug Administration (FDA) is aware of a potential
safety issue related to Avandia (rosiglitazone), a drug approved to
treat type 2 diabetes. Safety data from controlled clinical trials
have shown that there is a potentially significant increase in the
risk of heart attack and heart-related deaths in patients taking
Avandia. However, other published and unpublished data from
long-term clinical trials of Avandia, including an interim analysis
of data from the RECORD trial (a large, ongoing, randomized open
label trial) and unpublished reanalyses of data from DREAM (a
previously conducted placebo-controlled, randomized trial) provide
contradictory evidence about the risks in patients treated with
Avandia.
Patients who are taking Avandia, especially those who are known to
have underlying heart disease or who are at high risk of heart
attack should talk to their doctor about this new information as
they evaluate the available treatment options for their type 2
diabetes.
FDA's analyses of all available data are ongoing. FDA has not
confirmed the clinical significance of the reported increased risk
in the context of other studies. Pending questions include whether
the other approved treatment from the same class of drugs,
pioglitazone, has less, the same or greater risks. Furthermore,
there is inherent risk associated with switching patients with
diabetes from one treatment to another even in the absence of
specific risks associated with particular treatments. For these
reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to
take any specific action at this time. FDA is providing this
emerging information to prescribers so that they, and their
patients, can make individualized treatment decisions.
"FDA remains committed to assuring that doctors and patients have
the latest information available to make treatment and medication
use decisions. In this case, FDA is carefully weighing several
complex sources of data, some of which show conflicting results,
related to the risk of heart attack and heart-related deaths in
patients treated with Avandia," said Steven Galson, M.D., M.P.H.,
director of FDA's Center for Drug Evaluation and Research. "We will
complete our analyses and make the results available as soon as
possible. FDA will take the issue of cardiovascular risk associated
with Avandia and other drugs in this class to an Advisory Committee
as soon as one can be convened."
Avandia was approved in 1999 for treatment of type 2 diabetes, a
serious and life threatening disease that affects about 18 to 20
million Americans. Diabetes is a leading cause of coronary heart
disease, blindness, kidney failure and limb amputation. Since the
drug was approved, FDA has been monitoring several heart-related
adverse events (e.g., fluid retention, edema and congestive heart
failure) based on signals seen in previous controlled clinical
trials of Avandia alone and in combination with other drugs, and
from postmarketing reports. FDA has updated the product's labeling
on several occasions to reflect these new data, most recently in
2006. The most recent labeling change for Avandia also included a
new warning about a potential increase in heart attacks and
heart-related chest pain in some individuals using Avandia. This
new warning was based on the result of a controlled clinical trial
in patients with existing congestive heart failure.
Recently, the manufacturer of Avandia provided FDA with a pooled
analysis (meta analysis) of 42 randomized, controlled clinical
trials in which Avandia was compared to either placebo or other
anti-diabetic therapies in patients with type 2 diabetes. The
pooled analysis suggested that patients receiving short-term (most
studies were 6-months duration) treatment with Avandia may have a
30-40 percent greater risk of heart attack and other heart-related
adverse events than patients treated with placebo or other
anti-diabetic therapy. These data, if confirmed, would be of
significant concern since patients with diabetes are already at an
increased risk of heart disease.
Avandia is manufactured by GlaxoSmithKline, which is based in
Research Triangle Park, N.C.
