Reports of Diabetes Drug Acidic Side Effects Triple

In the month after a surprising analysis
revealed possible heart risks from the
blockbuster diabetes drug Avandia, reports
of side effects to federal regulators tripled.

The sudden spike is a sign that doctors
probably were unaware of the drug's possible
role in their patients' heart problems and
therefore may not have reported many such
cases in the past, several experts said.

It also shows the flaws of the safety tracking
system and suggests that a better one might
have detected a potential problem before the
drug had been on the market for eight years.

Avandia is used to control blood sugar, helping
more than 6 million people worldwide manage
Type 2 diabetes, the kind that is linked to
obesity. These people already are at higher
risk for heart attacks, so news that the drug
might raise this risk by 43 percent was
especially disturbing.

In the 35 days after May 21, when the New
England Journal of Medicine published the
analysis on the Internet, reports of heart
attacks, deaths and hospitalizations leaped.

The sharp rise in reports of heart problems
appears in data obtained by The Associated
Press through a Freedom of Information Act
request to the federal Food and Drug
Administration.

Only five heart attacks were reported in the
35 days before the study, compared with 90 in
the same period afterward. Heart-related
hospitalizations went from 11 to 126. The
reports involve rosiglitazone, sold as Avandia
and Avandamet.

Reporting a drug's side effects is voluntary,
and only a crude indication rather than a
scientific measure of how many problems patients
are actually having. The FDA relies on this
unenforced system once a drug is on the market.

Critics say it leads to haphazard oversight in
which problems can be missed because doctors
don't connect the dots between a drug and
symptoms they see in an individual patient.

With Avandia, the published analysis likely
led to more cases being reported, said
Vanderbilt University diabetes specialist
Dr. Alvin C. Powers.

"Now, patients and their doctors are much
more aware of the possible link between
Avandia and cardiovascular disease. This is
good - this is going to help us going forward
to determine whether or not this drug is safe,"
he said.

The drug's manufacturer, British-based
GlaxoSmithKline PLC, insists that the drug is
safe and effective.

"This is a very well-known phenomenon," where
news reports lead to increased reporting, said
company spokeswoman Mary Anne Rhyne. "It's good
that there's awareness of the reporting system,
but drawing conclusions on such data is
inappropriate."

The FDA plans hearings on safety concerns about
the drug on July 30. In the meantime, diabetes
experts have advised users of the medication to
talk to their doctors and not to immediately
discontinue it.

The side effects reported range from as minor
as a blister to as serious as sudden cardiac
death. Most of the reports the AP reviewed
seemed to involve serious side effects, and
rosiglitazone was listed by the FDA as the
"primary suspect" rather than other medicines
the patient may have been taking.

Avandia's label warns about possible heart
failure and other heart problems when taken
with insulin. The drug also raises LDL, or
bad cholesterol, and can cause fluid retention
and weight gain.

May suggest here is to let your food be your
medicine and your medicine be your food and
then you can put away your worry about the
acidic side-effects of taking this drug.

May I also suggest reading the pH Miracle for
Diabetes which outlines a natural approach for
reversing Type I and Type II diabetes.

For information on how to balance your blood
sugars naturally go to:

www.phmiracleliving.com

Reference:

Associated Press
The pH Miracle for Diabetes