FDA ISSUES A SAFETY ALERT ON DIABETES MEDICATIONS CAUSING HEART ATTACKS

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published and unpublished data from long-term clinical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open label trial) and unpublished reanalyses of data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 analysis 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 post-marketing 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 health warning about a potential
increase in heart attacks and heart-related chest
pain in some individuals using Avandia. This new health
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.
This data, if confirmed, would be of significant
concern since patients with diabetes are already
at an increased risk of heart disease.

The simple solution according to Dr. Robert O. Young,
a research scientist at the pH Miracle Living Center,
states, "stop doing diabetes with acidic lifestyle
and dietary choices. No one needs to be at risk
for heart attack and other heart-related adverse
events if they maintain the alkaline design of their
body. Diabetes is not a disease it is a result of
lifestyle and dietary choice. So stop doing diabetes
and start doing energy, health and vitality with the
pH Miracle for Diabetes plan. It is that simple."

Dr. Young further states, "we need more education,
not more medication."

To learn more about the cause of diabetes, heart
dis-ease and other heart-related adverse effects
please read, The pH Miracle for Diabetes.

http://www.phmiracleliving.com/books.htm