The VMD has suspended the marketing and use of Velactis in the UK.
This prescription only veterinary medicine, marketed by CEVA Sante Animale, the Marketing Authorisation Holder (MAH) contains the active substance cabergoline, and is used in the herd management programme of dairy cows as an aid in abrupt drying-off, by reducing milk production.
The product was authorised through the European Medicines Agency (EMA) in December 2015 and was first sold in the UK in April 2016.
The VMD has been made aware of reports of serious adverse events, predominantly occurring in Denmark, involving recumbency (lying down and unable to rise) and some deaths. Most adverse events occurred within 8 to 24 hours following product administration. Anecdotal evidence suggests that hypocalcaemia treatments may be successful in reversing clinical signs.
CEVA Sante Animale stopped further distribution of the product in Europe last month pending the outcome of an (urgent) review by the EU’s scientific committee, The Committee for Medicinal Products for Veterinary Use (CVMP). The CVMP has now advised the European Commission to suspend the authorisation of Velactis and to order Ceva Sante Animale to recall the product from the supply chain pending the outcome of further investigations to assess a possible causal link between the product and the adverse events reported. The nature and use of the product means that there is no risk to human health or consumer safety.
The use of Velactis in the UK is now suspended.
CEVA Sante Animale has initiated a voluntary product recall.
We strongly encourage vets and farmers to submit to the VMD any outstanding reports of adverse events associated with use of Velactis using our online reporting form or directly to CEVA Sante Animale for further investigation by the MAH as necessary.
More detailed information is available on the EMA website.