Advisory - Three lots of antidiuretic DDAVP Spray recalled because of potential overdose risk

OTTAWA, July 16, 2020 /CNW/ -

Summary

DDAVP Spray, 2.5 mL (CNW Group/Health Canada)

DDAVP Spray, 5 mL (CNW Group/Health Canada)

• Product: DDAVP Spray (desmopressin acetate nasal solution, 10 micrograms/spray)
• Issue: Three lots are being recalled because the product may contain a higher than labelled dose of the active ingredient (desmopressin) and could pose an overdose risk.
• What to do: Check the lot number on your product or contact your pharmacist to determine whether your product is being recalled. If you have a recalled product, contact your healthcare provider immediately to obtain a replacement.

Issue
Ferring Inc. is recalling three lots of DDAVP Spray (desmopressin acetate nasal solution, 10 micrograms/spray) because the product may contain a higher than labelled dose of the active ingredient (desmopressin) and could pose an overdose risk.

DDAVP Spray is a prescription antidiuretic drug used to treat an uncommon brain disorder called central diabetes insipidus (genetic or acquired) caused by a deficiency of antidiuretic hormone (ADH). It is also used to control temporary frequent urination, extreme thirst, and loss of water following head trauma or surgery in the pituitary gland in the brain.

Taking too much desmopressin may cause headache, nausea, vomiting, abdominal cramps, facial flushing and weight gain because of water retention and, in severe cases, convulsions.

Health Canada is monitoring the company's recall and will inform Canadians if new safety information becomes available.

Who is affected
Patients who are taking the recalled product.

Products affected

Company	Product Name	DIN	Strength	Lot	Expiry
Ferring Inc.	DDAVP Spray, 2.5 mL	00836362	10 µg/spray	R11524L	31-Mar-21
	DDAVP Spray, 2.5 mL			S10153C	31-Dec-21
	DDAVP Spray, 5 mL			R14720C	30-Sep-21

What you should do

• Check the lot number on your product or contact your pharmacist to determine whether your product is being recalled.
• If you have a recalled product, consult your healthcare provider immediately to obtain a replacement. This medication (desmopressin) is important to treat or control your condition; it is advisable that you do not miss a dose.  
• If you become aware of any unusual symptoms or side effects that may be associated with overdose of this product, contact your healthcare provider.
• Report any health product-related adverse reactions or complaints to Health Canada.
• If you have any questions regarding the recall, contact Ferring Inc. at 1-866-384-1314.

SOURCE Health Canada

Media enquiries: Health Canada, [phone], [email protected] ; Public enquiries, [phone], 1-866 225-0709, [email protected]