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From: GlaxoSmithKline
August 2007
Important
Prescribing Information
GlaxoSmithKline
(GSK) is fully committed to the timely communication of safety
information about its products to the healthcare community. In
collaboration with the U.S. Food and Drug Administration, we are
updating the rosiglitazone prescribing information with regard to
heart failure. This labeling affects rosiglitazone-containing
products, i.e. Avandia® (rosiglitazone maleate) tablets,
Avandamet (rosiglitazone maleate and metformin hydrocloride) tablets,
and Avandaryl (rosiglitazone maleate and glimeperide) Tablets, which
are used in treating type 2 diabetes melitus.
Important
changes to the Prescribing Information for Avandia, Avandamet and
Avandaryl include:
1. Boxed
warning regarding heart failure...
2.
Contraindication for initiation of rosiglitazone in patients with
NYHA class III and IV heart failure.
WARNING: CONGESTIVE HEART FAILURE
.
Thiazolidinediones, including rosiglitazone, cuase or exacerbate
congestive heart failure in some patients. After initiation of
Avandia, and after dose increases, observe patients carefully for
signs and symptoms of heart failure (including excessive, rapid
weight gain, dyspnea, and / or edema). If these symptoms
develop, the heart failure should be managed according to current
standards of care. Futhermore, discontinuation or dose
reduction of AVANDIA must be considered.
. AVANDIA is
not recommended in patients with symptomatic heart failure.
Initiation of AVANDIA in patients with establised NYHA Class III or
Class IV heart failure is contraindicated.
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