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
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
-- 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.
7333 Mississauga Road
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
Original signed by
Dr. Glenn Crater,
Vice President, Medical and Chief Medical Officer
(®)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.
-0- Apr/24/2013 12:00 GMT
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