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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). - For the Public
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(PDF Version - 651 K)Contact: Marketed Health Products Directorate (MHPD)
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 Apotex Inc.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on Apo-Desmopressin Spray
July 31, 2008
Subject: 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).
Primary Nocturnal Enuresis is a medical term for night-time bed-wetting. This means that a child continues to bedwet past the age when most children are successfully toilet trained. This is a common problem which most children will outgrow by age 6 years. Bedwetting is sometimes treated with a drug called desmopressin which is available in tablets and nasal spray formulations.
Apotex Inc., in collaboration with Health Canada, wishes to advise you that all nasal spray formulations of desmopressin, including Apo-Desmopressin Spray, must NOT be used to treat Primary Nocturnal Enuresis, as new safety information has found that the nasal spray formulations are associated with a higher risk of a serious, potentially life-threatening side effect known as hyponatremia than oral tablets. Hyponatremia is caused by increased water retention and decreased blood sodium levels, and can lead to seizures or death if not treated.
- Desmopressin nasal spray must NOT be used to treat night-time bedwetting.
- Patients currently being treated for bedwetting with desmopressin nasal spray should see their doctors to determine if desmopressin treatment is still required.
- Oral desmopressin tablets are available if medical treatment of bedwetting is considered necessary.
- Patients (parents/caregivers of patients) using desmopressin must be very careful to monitor their fluid intake carefully in order to reduce the possibility of water retention and hyponatremia, especially in very young and elderly patients, in hot weather, with strenuous exercise, or during illnesses causing fever.
- Certain symptoms, such as headache, nausea or vomiting, may be warning signs of water retention or decreased blood sodium levels. If such symptoms occur, desmopressin should be discontinued and medical attention sought immediately.
Apotex Inc. will be updating the Canadian prescribing information for Apo-Desmopressin Spray, and has sent a letter to Canadian healthcare professionals to make them aware of this new safety information. A copy of that letter is available on the Health Canada website.
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 serious or unexpected adverse reactions in patients receiving Apo-Desmopressin Spray should be reported to Apotex Inc, or Health Canada at the following addresses:
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 AR Reporting Form and the AR 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
