TORONTO, July 12, 2012 /CNW/ -
Subject: Contraindication regarding the use of VOLIBRIS® (ambrisentan) in patients with Idiopathic Pulmonary Fibrosis (IPF)
GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of new safety information regarding the use of VOLIBRIS® in patients with idiopathic pulmonary fibrosis (IPF) [idiopathic means arising without a known cause]. Higher rates of disease progression or deaths were observed during a prematurely discontinued clinical trial in IPF patients treated with VOLIBRIS®.
VOLIBRIS® (ambrisentan) is a prescription drug approved for use to treat idiopathic ('primary') pulmonary arterial hypertension (IPAH) and pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD), which is high blood pressure in the blood vessels between the heart and the lungs.
VOLIBRIS® is not approved for use in patients with IPF; nonetheless, the Product Monograph for VOLIBRIS® has been updated with important information for patients, described below and found at www.gsk.ca.
| When it should not be used:
Do not take VOLIBRIS® if:
GlaxoSmithKline has sent a letter to healthcare professionals informing them of this new safety information. This information may be obtained on the Canadian website of GlaxoSmithKline (www.gsk.ca) or on the Health Canada Web site. If you have questions regarding your VOLIBRIS® prescription, please contact your doctor.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Serious or unexpected adverse reactions in patients receiving VOLIBRIS® should be reported to GlaxoSmithKline or Health Canada.
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You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
To change your mailing address or fax number, contact the Market Authorization Holder (GlaxoSmithKline Inc.).
original signed by
Dr. Glenn Crater,
Vice-President, Medical and Chief Medical Officer
1. G. Raghu et al. ARTEMIS-IPF: A Placebo-Controlled Trial Of Ambrisentan In Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med 2012;185:A3632.
VOLIBRIS® is a registered trademark, used under license by GlaxoSmithKline Inc.
For further information:
For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363.