E-DRUG: Public Citizen and rosiglitazone
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19 November, 2007
Worst Pills, Best Pills Drug Alert
In May, a study in the New England Journal of Medicine linked the diabetes
drug rosiglitazone (AVANDIA, AVANDAMET and AVANDARYL) to heart attacks and
heart-related deaths. But the heart risks of this drug should not have been
a surprise.
Public Citizen has long warned about the dangers of using the glitazone
class of diabetes drugs, beginning with our petition to the Food and Drug
Administration (FDA) in 2000 for better warnings. We have classified
rosiglitazone as a Do Not Use drug for the past three years.
Since the release of the New England Journal of Medicine study, the
following actions have been taken:
1/ In October, the Department of Veterans Affairs, after conducting its own
review, removed rosiglitazone from its formulary (the drugs that its doctors
may prescribe), concluding that, "for some patients, rosiglitazone may not
afford the same margin of safety as alternative drug therapies."
2/ On November 6, 2007, Health Canada, the Canadian equivalent of the U.S.
FDA, issued broad new restrictions on the use of rosiglitazone. In Canada,
rosiglitazone is now no longer approved either as a single treatment for
diabetes (except for patients unable to take metformin), or for use in
combination with a sulfonylurea* except when patients are unable to take
metformin. Furthermore, Health Canada warns that rosiglitazone should not be used in any of these situations: in patients taking insulin, in combination with metformin and a sulfonylurea drug, or in patients diagnosed with any degree of heart failure, either past or current, even that which is very mild (NYHA Classes I, II, III, or IV).
Health Canada advises patients to talk to their doctors about the benefits
and risks of continuing therapy, especially those with heart disease or at a
high risk for a heart attack or heart failure.
3/ Shortly after the Canadian warning, on November 14, the FDA modified its
black box warning for rosiglitazone concerning heart attacks, but in a most
confusing fashion: it cites four analyses. One of the four is a
meta-analysis of 42 studies which showed an increased risk of heart attacks;
the results of the three others "have not confirmed or excluded this risk,"
according to the FDA. This is inaccurate and provides no useful guidance to
patients or their physicians.
The FDA needs to immediately publish an alert similar to that of Health
Canada to warn U.S. citizens who are at increased risk from heart attacks
and heart failure not to take rosiglitazone. Until then, Health Canada
remains the sole source of this vital information.
*We continue to label Avandia as a Do Not Use drug.*
www.citizen.org
See the new Health Canada restrictions on rosiglitazone here:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/2007/avandia_pc-cp_4_e.html
*Examples of sulfonylurea drugs are glyburide, glimepiride, and
tolbutamide.
--
Dr. Ruben Roa
Especialista en Medicina Familiar
http://atencionprimaria.wordpress.com
Skype: ruben-roa-
Buenos Aires - Argentina
ruben.roa@gmail.com