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
A clinical study in patients with IPF was prematurely discontinued as a
result of a lack of benefit shown in IPF patients taking VOLIBRIS when
compared to placebo. Evaluation of the data revealed higher rates of
disease progression (including decreases in respiratory function,
respiratory hospitalizations) or deaths in patients on VOLIBRIS® when compared to placebo.
If you have been diagnosed with IPF and you are currently taking
VOLIBRIS®, please speak with your doctor immediately.
VOLIBRIS® is not approved for use in patients with idiopathic pulmonary fibrosis
(IPF) and is now contraindicated; as such, if you have IPF, with or
without pulmonary hypertension, you should not take 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:
You have a lung condition called Idiopathic Pulmonary Fibrosis (IPF) that makes it
hard to breathe, along with a dry cough, and sometimes, joint pain or
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.
7333 Mississauga Road
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:
The Reporting Forms, postage paid labels, and Guidelines can be found on
the MedEffectTM Canada Web site in the Adverse Reaction Reporting section http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php). The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.
Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Reporting Form and:
Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
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.
SOURCE GLAXOSMITHKLINE INC.
For further information:
For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363.