Rosiglitazone is a thiazolidinedione, used in the
management of type 2 diabetes mellitus, alone or in combination therapy.
The
latest drug safety communication by US FDA on rosiglitazone containing diabetes
medicines requires the removal of the prescribing and dispensing restrictions
for rosiglitazone medicines that were put up in year 2010.
This
is based on the recent re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes
and Regulation of Glycemia in Diabetes (RECORD) trial data by Duke Clinical Research Institute
(DCRI) which did not show statistically
significant differences between the rosiglitazone and the
metformin/sulfonylurea groups for the composite end point of CV death, MI, or
stroke and the individual components. Still the concerns about the
cardiovascular safety remain due to this re-evaluation, but the prescribing
information and Risk Evaluation and Mitigation Strategy (REMS), called the
Rosiglitazone REMS program will be
modified.
Health care professionals,
pharmacies, and patients will no longer be required to enroll in the
rosiglitazone REMS program to be able to prescribe, dispense, or receive
rosiglitazone medicines.
History of changes in the prescribing
information
09/23/2010
US FDA restricted
the use of rosiglitazone to patients of type 2 DM who cannot control their
diabetes on other medications. This was following the data from a large,
combined analysis of mostly short-term, randomized clinical trials of
rosiglitazone which had suggested an elevated risk of heart attack.
FDA required a Rosiglitazone
REMS program. The Rosiglitazone REMS program restricted the use of
rosiglitazone medicines to help ensure that their benefits outweighed the
risks.
02/04/2011
Information
on cardiovascular risks added to the physician label and medication guide.
05/18/2011
The
new REMS included a restricted access and distribution program for all the three
products containing rosiglitazone (Avandia, Avandamet and Avandaryl)
11/04/2011
Healthcare
professionals to enroll in the Avandia-Rosiglitazone Medicines Access Program
if they wished to prescribe rosiglitazone medicines to outpatients or patients
in long-term care facilities.
References
4.
Results of a reevaluation of
cardiovascular outcomes in the RECORD trial. http://www.ncbi.nlm.nih.gov/pubmed/23895806
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