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DDAVP Spray (desmopressin acetate nasal spray) and DDAVP Rhinyle (desmopressin acetate nasal solution) have been associated with an increased risk of hyponatremia - For the Public
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(PDF Version - 67 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 Ferring Pharmaceuticals.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on desmopressin (DDAVP Spray, DDAVP Rhinyle Solution)
July 15, 2008
Subject: Public Communication for New Safety Information regarding desmopressin (DDAVP® Spray, DDAVP® Rhinyle Solution)
Ferring Pharmaceuticals, in cooperation with Health Canada, wishes to inform Canadians about new safety information regarding desmopressin when it is used nasally for the treatment of bedwetting (also called Primary Nocturnal Enuresis or PNE). Because of increased risk of serious side effect with all nasal formulations, they are no longer indicated for use in patients with bedwetting.
Desmopressin can cause water retention that could lead to a low blood sodium level (hyponatremia). Hyponatremia is rare but serious and if unrecognized, can lead to seizures and even death.
- Bedwetting must not be treated with any nasal form of desmopressin (e.g., DDAVP® Spray, DDAVP® Rhinyle Solution). It must only be treated with desmopressin taken by mouth (e.g., DDAVP® Melt).
- If you or your child is currently taking a nasal form of desmopressin (Spray or Rhinyle) for bedwetting, you should talk to your doctor to see if you need to continue on desmopressin treatment. If continued treatment is necessary, you should be changed over to an oral form.
- If you are a new patient needing desmopressin treatment for bedwetting you should only be given an oral form.
If you face a situation where increased water intake can be expected, for example; hot weather, after lots of exercise or during illnesses causing fever, you should seek advice from your physician. Your doctor will advise you on how to reduce the risk of side effects by monitoring fluid intake.
Certain medications when taken with desmopressin have been associated with serious side-effects. Make sure you tell your doctor or pharmacist if you or your child takes other medications, for example anti-depressants or anti-inflammatory drugs.
Ferring Inc. has worked with Health Canada to update the prescribing information for DDAVP Spray and DDAVP Rhinyle solution and has sent a letter to health care professionals and pharmacists to inform them 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 DDAVP Spray and DDAVP Rhinyle Solution should be reported to Ferring Inc. Canada or Health Canada at the following addresses:
Ferring Inc,
200 Yorkland Boulevard, Suite 800
North York, Ontario
M2J 5C1
Tel: 1-800-263-4057
Fax: 416-493-1692
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
Should you have any questions or require additional information regarding the use of DDAVP Spray and DDAVP Rhinyle Solution please contact Ferring Inc., Medical Information at 1-800-263-4057.
Sincerely,
original signed by
Dr. Anne Brusby M.D., MRCP (UK) FRCPC
Medical Director
Ferring Inc.,Canada
