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anses

French Agency for Food, Environmental and Occupational Health & Safety

ANSES calls for ceasing the use of VELACTIS® and recalling all batches, including from farms

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News of 26/07/2016

Following several reports of serious adverse effects related to the veterinary drug VELACTIS®, ANSES has suspended the use of this medicine. The Agency has asked veterinarians to no longer prescribe VELACTIS®A recall of all batches has been initiated and farmers are invited to return all unused products to their veterinarians.

 

Serious adverse events, which may lead to the death of dairy cows, have been observed following the use of VELACTIS®, a veterinary medicinal product used as a herd management aid for drying off dairy cows.

Since the drug was launched at the end of March 2016, pharmacovigilance reports have been recorded in Europe concerning 319 cows treated for approximately 40,000 doses sold. In France, fourteen reports have been recorded, eleven of them qualified as serious, via the veterinary pharmacovigilance system run by the French Agency for Veterinary Medicinal Products (ANSES-ANMV). While these effects are, a priori, related to the use of VELACTIS®, their exact cause remains to be identified.

Taking into account the severity and the number of reports, the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has recommended that the European Commission suspend the marketing authorisation for VELACTIS® until additional information becomes available.

Pending this decision, ANSES is suspending the use of VELACTIS® and has asked veterinarians to no longer prescribe the drug and livestock farmers to cease using it.

Ceva Santé Animale, which markets VELACTIS®, has already implemented the recall of all batches of the drug: farmers are therefore being asked to return all unused products to their veterinarians.