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Mesna (Uromitexan), Multi-Dose Vials - Association with Fatal Gasping Syndrome in Neonates and Infants - For the Public
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(PDF Version - 19 K)Contact: Marketed Health Products Directorate
The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Baxter Corporation.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on UROMITEXAN (Mesna Injection) 100mg/mL
August 15, 2011
Subject: Association of mesna (Uromitexan), multi-dose vials with fatal gasping syndrome in children
This letter is being sent out following consultation with Health Canada regarding mesna (Uromitexan) multi-dose vials which was recently approved in Canada. Baxter Corporation is issuing this letter to ensure that prescribers have the most recent information available when considering mesna (Uromitexan) as a treatment option in the prevention of blood in urine.
Mesna (Uromitexan), multi-dose vials is indicated for the reduction and prevention of bleeding from the bladder caused by the treatment with a group of drugs called oxazaphosphorines (such as Ifosfamide, Glufosfamide and Cyclophosphamide).
- Mesna (Uromitexan), multi-dose vials is indicated for use in adults and children 13 years and older only. However, this product has been reported to be used off-label in younger patients.
- There have been reported cases of a fatal respiratory syndrome in children associated with the use of drugs containing the preservative benzyl alcohol.
- Prescribers have been advised to use this product as per its approved use.
To read the full content of the Dear Health Professional Letter (DHPL) for Mesna (UROMITEXAN), Multi-Dose Vials - Association with Fatal Gasping Syndrome in Neonates and Infants - For Health Professionals.
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. Any case of fatal or life-threatening respiratory syndrome or other serious or unexpected adverse reactions in patients receiving UROMITEXAN should be reported to Baxter Corporation or Health Canada.
Mississauga, Ontario
1-888-719-9955
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect™ Canada
- Call toll-free at 1-866-234-2345
- Complete a Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
K1A 0K9
The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction and Medical Device Problem Reporting section.
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738
Sincerely,
original signed by
Adel Gehchan, MD
Director, Medical and Clinical Affairs
Baxter Corporation
References:
- Product Monograph, PrUROMITEXAN (mesna Injection) 100mg/mL, August 2011
Promoting Safety of Medicine for Children (PDF Version - 1,005 K)
