Other safety alerts
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| European Union: Senvelgo (velagliflozin) oral solution: known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus |
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European Medicines Agency (EMA) announces that following a review of cases of diabetic ketoacidosis (DKA, a potentially fatal complication of diabetes mellitus) in cats given the medicine Senvelgo, the Committee for Veterinary Medicinal Products (CVMP) has agreed on a direct animal healthcare professional communication (DaHPC) with important information about the safe use of the medicine, including those situations that may require immediate intervention.
Senvelgo is used to reduce hyperglycaemia (high blood glucose levels) in cats with non-insulin-dependent diabetes mellitus. Before starting treatment with Senvelgo, cats must be screened for DKA and treatment should not be started if clinical signs indicative of DKA are present. Not all diabetic cats may be suitable for treatment with Senvelgo, especially those currently being treated with insulin, and careful patient selection is important. Diabetic cats pre-treated with insulin have a higher risk of developing DKA and ketonuria (high ketone levels in urine) when Senvelgo is started, compared to newly diagnosed cats.
Cases of DKA and deaths have been reported in cats given Senvelgo, including cases where unsuitable cats were switched from insulin to Senvelgo. Most DKA cases occurred within four days after starting treatment with Senvelgo. Based on pharmacovigilance adverse event reports, it is important to screen for the presence of ketone bodies every day during the first week of treatment, and every one to three days in the following week. In addition, blood testing for ketones should ideally be performed within this first 2-week period.
Veterinarians should inform cat owners of the risk of DKA, and seek to ensure that cat owners are able to adequately monitor their cats for potential development of this condition. Cat owners should immediately consult a veterinarian if they observe clinical signs of DKA such as weight loss, dehydration, lethargy (lack of energy), anorexia (loss of appetite), vomiting, cachexia (muscle wasting with significant weight loss) or if ketones are detected in the cat’s urine (e.g. using urine test strips).
If DKA or diabetic ketonuria are suspected or confirmed, treatment with Senvelgo must be stopped immediately. Appropriate investigation and immediate initiation of appropriate therapy (e.g. insulin therapy to stop the progression of ketoacidosis) is required.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-committee-veterinary-medicinal-products-cvmp-16-18-july-2024
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Saturday, Jul 20, 2024
Issued at HKT 12:00
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