EMA reviewing veterinary medicine Velactis

News 24/06/2016

Review triggered by serious adverse events in cattle

The European Medicines Agency (EMA) is reviewing the veterinary medicine Velactis (cabergoline) after serious adverse events, including recumbency (lying down or inability to stand up) and death, were observed following the use of this product in cattle.

Velactis was authorised in the European Union (EU) in December 2015 for use in the herd management programme of dairy cows, as an aid in the abrupt drying-off. Drying-off is a management technique to stop the production of milk in cows that are still lactating in order to prepare for calving and the next lactation period. Velactis contains the active substance cabergoline which blocks release of the hormone prolactin, and thus reduces milk production and aids in the drying-off.

The marketing authorisation holder for this medicine informed EMA of serious adverse events observed after the use of the product in cattle. It is estimated that since March 2016, 40,000 doses of the medicine have been administered to cows in the EU. 100 adverse event reports have been received, including 66 reports of recumbency involving 98 animals, as well as less frequent reports of animals suffering from hypothermia (drop in temperature), hypocalcaemia (clinical signs often seen with low calcium levels/milk fever), rumen (ruminant stomach) disorder, diarrhoea, circulatory disorder, ataxia (involuntary muscle movements) and adipsia (loss of thirst). Some of those events (17 reports involving 22 cows) resulted in the death or euthanasia of the animal.

At its 14-16 June 2016 meeting, EMA's Committee for Medicinal Products for Veterinary Use (CVMP) discussed the new data and their possible implications for animal health. The CVMP noted that the events were observed following administration of the product (usually within 24 hours) but it is not yet clear whether the product has caused the adverse events observed, whether the events are due to other factors, or a combination of the two.

Upon the request of the European Commission, the CVMP started an urgent review of the new data to assess whether the benefits of this medicine continue to outweigh its risks and whether any changes are needed in the way it is used in the EU.

While the review is ongoing, the marketing authorisation holder has halted the release of any further product into the distribution chain. Depending on the situation in their territory, national competent authorities may take additional interim action pending the outcome of the CVMP review, if judged necessary to protect animal health. In line with this, EMA is aware that in Denmark, the authorities have decided to suspend the use of the product. Denmark is one of the first EU countries where the medicine was launched and where the majority of the adverse events have been observed.

The concerns that are under investigation do not relate to food safety. As for all products intended for food-producing animals withdrawal periods have been established which ensure that food commodities (milk and meat) of animals treated with Velactis are safe for the consumer. The withdrawal period is the time required after administration of the medicine before the animal can be slaughtered or food products (e.g. milk) be used for human consumption.

Advice for veterinarians

Veterinary surgeons will receive targeted communication to inform them of the situation and to remind them to ensure that the product is used in compliance with the product information and also to note the best practice guide for dry-off from the marketing-authorisation holder. This guidance from CEVA Santé Animale recommends not to make management or nutritional changes in addition to the use of Velactis in order to reduce milk production.

Veterinarians are also asked to advise farmers to keep treated animals, in particular high yielding cows, under close supervision for at least 24 hours and to apply supportive therapies as required (e.g. treatment for hypocalcaemia, if deemed appropriate).

EMA, in collaboration with Member States and the marketing authorisation holder, has intensified the surveillance of adverse events for Velactis in order to gather further information to support the ongoing investigations and analysis of the data.

Veterinary surgeons are recommended to promptly report any adverse events (including lack of expected efficacy) observed following the use of Velactis in accordance with national reporting systems.

More about the procedure

The review of the benefit-risk balance of Velactis has been initiated upon the request of the European Commission, under article 45 of Regulation (EC) No.726/2004.

The review is being carried out by the CVMP, the EMA committee responsible for preparing opinions on questions concerning medicines for veterinary use, which will make a set of recommendations. This opinion should be delivered as soon as possible and no later than within three months. The CVMP aims to adopt the opinion at its plenary meeting to be held on 12-14 July 2016. EMA will communicate the final outcome of this review.

The CVMP recommendations will then be transmitted to the European Commission for the adoption of a legally binding decision applicable in all EU Member States. Meanwhile Member States can take precautionary action to restrict the use of the product in their territories if necessary on the basis of information emerging concerning the situation.

The marketing authorisation holder is the pharmaceutical company CEVA Santé Animale.

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