Other safety alerts
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| Australia: Medicines safety update: Water for injection and haemolysis |
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The Therapeutic Goods Administration (TGA) announces that health professionals are reminded that water for injection can cause haemolysis resulting in patient harm, including death, if large quantities are inadvertently administered intravenously without being rendered isotonic.
Water for injection, which is hypotonic, is indicated for dissolving or diluting injectable therapeutic substances for parenteral administration (where water is a suitable solvent). It is contraindicated for intravenous administration if it is not adjusted to isotonicity by the addition of suitable solutes.
The TGA is aware of international reports of mix-ups between 1 litre bags of water for injection and other 1 litre bags, including sodium chloride 0.9% and glucose 5%.
As with any therapeutic goods, water for injection products should always be used in strict accordance with all instructions for using the product. All registered injection products in Australia with a volume of 100 mL or more are required to include a statement on the label if the injection is hypotonic, hypertonic or isotonic.
Always carefully check the label to ensure there is no confusion between water for injection and other IV bags.
Please refer to the following website in TGA for details:http://www.tga.gov.au/publication-issue/water-injection-and-haemolysis
In Hong Kong, there are 11 registered pharmaceutical products containing only water for injection (WFI) for human parenteral administration, and all products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to WFI. Healthcare professionals should check the product label carefully and follow the product instructions accordingly.
Ends/ Friday, Jun 26, 2020
Issued at HKT 14:00
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