DOC News October 1, 2007
Volume 4 Number 10 p. 14
© 2007 American Diabetes Association
A Much-Disputed Drug
When a study recently published in the New England Journal of
Medicine suggested a link between rosiglitazone (Avandia, GlaxoSmithKline)
and an increased risk of heart attacks, reaction was swift and
loud.1
Some called for the drug's withdrawal from the U.S. market, some
recommended the drug be given more limited indications and strongly worded
warnings, while others claimed the study was flawed and concerns about Avandia
overblown.
In the end, Avandia remained on the market, with an added black-box
warning about the potential for heart failure but not heart attack (DOC
News, September 2007, page 10). Still, questions remain about the Food and
Drug Administration's handling of Avandia and whether the media-induced panic
about the drug in the study's wake was warranted.
DOC News asked:
Has the response to the rosiglitazone meta-analysis been appropriate?
Did I have a kneejerk response and call all my patients and have them stop
it? No. I've had patients call who are concerned, and I've taken them off it
and given them other options. The dust needs to settle on this. We've known
for a long time that rosiglitazone is contraindicated in people with
congestive heart failure. Fluid retention is one of the major side effects,
which can make cardiovascular disease worse.
I don't put any of my patients with congestive heart failure on
rosiglitazone. Because it's available to anyone, sometimes it gets into the
hands of people—primary care providers or family physicians—who
don't look closely at some of those warnings.
Debra Rutkowski, APRN, CDE Family Nurse Practitioner Johnson City, N.Y.
I think the response has been very appropriate. I'm not skilled enough to
do a statistical analysis of the information, but it was published in a
prestigious peer-reviewed journal. As clinicians, our duty is to keep patients
safe. I have stopped all prescriptions for rosiglitazone and am using
alternative therapies. And I'm making sure my patients understand that the
matter is not 100% settled.
I have a professional responsibility to not cause harm, or even risk harm
when there are good therapeutic alternatives. One heart attack makes a
difference to the person having a heart attack.
Sally Pinkstaff, MD Endocrinologist Baltimore
The New England Journal of Medicine manipulated the state of
affairs because of the need to correct an over-representation of those drugs
being beneficial over the last decade. It's a backlash to things being
oversold. And the response has been rational.
Robert S. Sobel, MD Endocrinologist Chicago
When patients call, I tell them there's no compelling reason to take
rosiglitazone at this time. We're watching these other things
anyway—blood pressure, cholesterol, and all other health factors. They
should do away with the drug altogether.
Gerald W. Sobel, MD Endocrinologist Chicago
References
1. Nissen SE, Wolski K: Effect of rosiglitazone on the risk of
myocardial infarction and death from cardiovascular causes. N Engl
J Med 356:2457–2471, 2007.[Abstract/Free Full Text]
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