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

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 

    --  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) 

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
Telephone: 1-800-267-9675
Fax: 1-613-946-5636


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.

GlaxoSmithKline Communications at (905) 819-3363

SOURCE: GlaxoSmithKline Inc.

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CO: GlaxoSmithKline Inc.
ST: Ontario

-0- Apr/24/2013 12:00 GMT

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