Health Canada Endorsed Important Information on FLOLAN® (epoprostenol sodium)

Subject:  Updated Information - Potential for Glass-Related Particles in FLOLAN^® (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)

TORONTO, April 24, 2013 /CNW/ - 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 [phone].

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:  [phone]

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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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: [email protected]
Telephone: [phone]
Fax: [phone]

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.

SOURCE: GlaxoSmithKline Inc.

For further information:

GlaxoSmithKline Communications at [phone]