Volibris (ambrisentan) - Contraindication in Patients with Idiopathic Pulmonary Fibrosis (IPF) - For the Public

Starting date:

July 12, 2012

Posting date:

July 12, 2012

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-14803

This is duplicated text of a letter from GlaxoSmithKline Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on Volibris

July 12, 2012

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^®.

• 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 swelling.

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 or on the Health Canada Web site.  If you have questions regarding your Volibris^® prescription, please contact your doctor.

For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363.

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.

GlaxoSmithKline Inc.

7333 Mississauga Road

Mississauga, Ontario

L5N 6L4

Tel: 1-800-387-7374

To report suspected adverse reactions to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or visit the MedEffect™ Canada Web site for information on how to report.

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc.public@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

Dr. Glenn Crater,

Vice-President, Medical and Chief Medical Officer

GlaxoSmithKline Inc.

Volibris^® is a registered trademark, used under license by GlaxoSmithKline Inc.