Senvelgo® (velagliflozin) 15 mg/ml oral solution for cats
Known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus associated with the use of the product
Date: 08.08.2024
Senvelgo® 15 mg/ml oral solution for cats was first authorised in the European Union (EU) in November 2023. In a communication coordinated with the European Medicines Agency (EMA) and the competent authorities of the Member States, the marketing authorisation holder is now informing veterinarians about the correct use of the veterinary medicinal product in order to prevent possible risks associated with the development of diabetic ketoacidosis.
Senvelgo® 15 mg/ml oral solution for cats contains velagliflozin, an SGLT‐2 inhibitor. It is indicated to reduce hyperglycaemia in non‐insulin dependent diabetic cats. Since placing on the market of SENVELGO®, serious adverse events, including diabetic ketoacidosis (DKA) and fatalities, have been reported from post-marketing pharmacovigilance data. DKA is a known, potentially life-threatening complication of diabetes mellitus. The letter now circulated by the marketing authorisation holder aims to provide veterinarians with important information about the safe use of the product, particularly with regard to the correct selection and monitoring of patients, in order to minimise the occurrence of serious adverse events. The relevant information can also be found in the product information / summary of product characteristics (SPC).
The complete direct animal healthcare professional communication, as circulated by the marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH, can be found here.
Further Information:
Information on Senvelgo® on the EMA (European Medicines Agency) Website.
Year of issue
2024
Date
08.08.2024
Pressekontakt
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Presse und Öffentlichkeitsarbeit •
Gerichtstraße 49 •
13347 Berlin
Phone: 030 18444 -88250
• Fax: 030 18444 -89999
E-Mail: *
presse@bvl.bund.de