The VMD would like to make vets and farmers aware of adverse events following use of Velactis in dairy cattle and current regulatory actions in Europe.
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 have decided to voluntarily stop further distribution of the product in Europe pending the outcome of further investigations to assess a possible causal link between the product and the adverse events reported. The VMD, EMA, other agencies throughout Europe and the MAH are working closely to monitor the situation. We would also like to highlight that due to the nature and use of the product there is no risk to human health or consumer safety.
Vets and dairy farmers are strongly encouraged to report any adverse events associated with use of Velactis to the VMD using our online reporting form or directly to CEVA Sante Animale for further investigation by the MAH as necessary.
Source: Gov.uk (Contains public sector information licensed under the Open Government Licence v3.0.)