FLOLAN (epoprostenol sodium) - Potential for Glass-related Particles in Sterile Diluent - For the Public

Starting date:

April 24, 2013

Posting date:

April 24, 2013

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Contamination

Audience:

General Public

Identification number:

RA-26807

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 Information on ^PrFLOLAN^® (epoprostenol sodium)

April 24, 2013

Subject: Updated Information – Potential for Glass-Related Particles in ^prFLOLAN^® (epoprostenol sodium) Sterile Diluent and the Essential Use of a Filter with the Administration of the Reconstituted Product 
(FLOLAN^® 0.5 mg vial, DIN: 02230845; FLOLAN^® 1.5 mg vial, DIN: 02230848; Sterile Diluent DIN: 02230857)

GlaxoSmithKline Inc., in consultation with Health Canada, is providing Canadians with updated information on the use of the pulmonary hypertension drug, FLOLAN^®. Some vials of Sterile Diluent for FLOLAN^® have been found to contain glass-related particles that may not be easily visible under normal lighting conditions. Studies indicate filtration through a 0.22 or 0.2 micron pore size filter is an effective means to remove these glass-related particles. The infusion tubing supplied by your Pharmaprix/Shoppers Drug Mart Specialty Pharmacy already incorporates a 0.2 micron filter.

There have been no reports of adverse events that could be definitively attributed to these glass-related particles in GlaxoSmithKline’s safety database for FLOLAN^®. 

Based on this information, GlaxoSmithKline would like to advise you of the following:

• Some vials of Sterile Diluent for FLOLAN^® have been found to contain glass-related particles.
• When administering FLOLAN^® you must only use the infusion tubing supplied to you by your Pharmaprix/Shoppers Drug Mart Specialty Pharmacy.  This tubing already incorporates a 0.2 micron filter. 
• FLOLAN^® Sterile Diluent and reconstituted FLOLAN^® should be inspected for visible particles prior to use.  Product containing visible particles should not be used.

GlaxoSmithKline has sent a letter to healthcare professionals informing them of this safety information.  A copy of that letter will be available on the Health Canada Website.  

GlaxoSmithKline continues to search for improvements in the manufacturing process of the Sterile Diluent for FLOLAN^® so that no vials will contain glass particles. Since the continued availability of this product is medically necessary for patients who require FLOLAN^®, the use of a filter with the administration is essential for these patients. 

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

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them.  Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any serious or unexpected side effects in patients receiving FLOLAN^® should be reported to GlaxoSmithKline Inc. or Health Canada.

GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Phone:  1-800-387-7374

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to  report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Sincerely,

Original signed by

Dr. Glenn Crater,
Vice President, Medical and Chief Medical Officer
GlaxoSmithKline Inc.

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