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Desmopressin Nasal Sprays (including Apo-Desmopressin Spray) are associated with an increased risk of serious side effects involving water retention and decreased blood sodium levels (hyponatremia). - Notice to Hospitals
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(PDF Version - 692 K)Contact: Marketed Health Products Directorate (MHPD)
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This is duplicated text of a letter from Apotex Inc.
Contact the company for a copy of any references, attachments or enclosures.
NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on
Apo-Desmopressin Spray
July 31, 2008
Dear Chief of Medicine,
Please distribute to relevant Departments -Surgery, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Internal Medicine, Intensive Care and/or other Departments as required, and other involved professional staff and post this Notice in your institution.
Subject: Association of increased risk of hyponatremia/water intoxication with all intranasal spray formulations of the antidiuretic drug desmopressin, including Apo-Desmopressin Spray
Apotex Inc., in collaboration with Health Canada, wishes to advise you that all intranasal formulations of the antidiuretic drug desmopressin, including Apo-Desmopressin Spray, are now contraindicated for the treatment of Primary Nocturnal Enuresis, as international post-market data has indicated intranasal formulations of desmopressin are associated with greater risk of hyponatremia than oral formulations. Hyponatremia is a serious, potentially fatal, adverse reaction caused by water retention resulting from the potent antidiuretic effect of desmopressin. If unrecognized, hyponatremia can lead to seizures and death.
- All intranasal formulations of desmopressin are now contraindicated for the treatment of Primary Nocturnal Enuresis (PNE).
- All patients using intranasal formulations of desmopressin should be reassessed to determine whether ongoing treatment with desmopressin is necessary. If continued desmopressin therapy is required, patients should be switched to the lowest starting dose of an oral desmopressin formulation, with the dose only increased if necessary to control symptoms.
- Fluid intake and desmopressin dosage should be adjusted carefully in order to reduce the possibility of water retention and hyponatremia especially in very young and elderly patients or when significant daily variables occur such as hot climate conditions, intense exercise or other situations where increased water intake can be expected.
- Prodromal symptoms such as headache, nausea or vomiting may herald impending hyponatremia. A patient treated with desmopressin for PNE and/or their guardian should be advised that if such symptoms occur, desmopressin should be discontinued and medical attention sought immediately.
Apotex Inc. will be updating the Indications and Clinical Use, Contraindications, Warnings and Precautions, Adverse Reactions, Drug Interaction and Dosage and Administration sections of the Canadian Product Monograph for Apo-Desmopressin Spray to include the new contraindication for the treatment of Primary Nocturnal Enuresis and other important safety information regarding the risk of hyponatremia.
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 serious hyponatremia/water intoxication or other serious or unexpected adverse reactions in patients receiving Apo-Desmopressin intranasal spray formulation should be reported to Apotex Inc, or Health Canada at the following addresses:
Apotex Inc.
150 Signet Drive
Toronto, ON
M9L 1T9
Tel: 800-667-4708
Fax: 416-401-3819
E-mail: drugsafety@apotex.com
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca
The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel: 613-954-6522
Fax: 613-952-7738
Sincerely,
original signed by
Dr. Bruce D. Clark, Ph.D.
Vice-President, Regulatory & Medical Affairs
