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 the product in cattle.
Although the product was not launched in Ireland, and there are no reports of suspected adverse events in this country, the Health Products Regulatory Authority has issued the advisory notice, in case Velactis is imported from another Member State.
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.
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 in the EU.
