The European Medicines Agency’s (EMA) has recommended suspending the marketing authorisation of Velactis, a treatment used to reduce milk production in dairy cows at drying off.
The Committee for Medicinal Products for Veterinary Use (CVMP) recommendation follows reports of adverse events in 319 dairy cows after treatment with Velactis.
Many of the adverse events were serious, including recumbency in 208 animals, which generally occurred within 24 hours of administering Velactis. In total, 71 deaths were reported in cows – most after a period of recumbency.
Although the exact cause of these adverse events is yet to be determined, there is evidence to suggest they may be linked to the use of Velactis.
Given the number and severity of adverse events following use of the medicine in otherwise healthy dairy cows, the committee concluded that, at present, the risks outweigh the benefits of the product.
The CVMP therefore recommended the marketing authorisation for Velactis be suspended in the EU until further information is available to show the benefits outweigh the risks – possibly under new conditions of use or restrictions.
The committee also recommended, as a precautionary measure, a recall of Velactis currently on the market in the EU. The use of the medicine has already been suspended by national authorities in some EU member states and the company has informed EMA it has suspended sales in the EU.
The CVMP’s recommendations will now be sent to the European Commission for a legally binding decision applicable in all EU member states.