Advisory notice relating to serious adverse events involving recumbency and death in cattle (dairy cows) following use of Velactis in Europe

Notice type: Advisory

Date: 27/06/2016

The European Medicines Agency (EMA) and national competent authorities (NCAs) including the HPRA, have been made aware by Ceva Santé Animale of adverse events concerning recumbency and death in cattle (dairy cows) which the marketing authorisation holder (MAH) considers to be a validated signal. 
Velactis is a prolactin inhibitor containing cabergoline authorised for use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to reduce milk leakage at drying off, reduce the risk of new intramammary infections during the dry period, and reduce discomfort. 
Velactis is authorised under a Community authorisation procedure. Although the product has not yet been launched in Ireland, and there are no reports of suspected adverse events in this country, it is considered prudent to issue this advisory notice, in case Velactis is imported from another Member State.  

Product name or type:

Authorisation Number:

Active Substance:

Product Classification:
prolactin inhibitor 

Manufacturer Or Supplier:
Ceva Santé Animale 

Authorisation Holder:
Ceva Santé Animale

Prescription Required:

Target Audience:
Veterinary practitioners

Problem Or Issue:
The product was authorised in December 2015 and initially placed on the European Union (EU) market in March 2016, however the product has not yet been launched in Ireland. In the EU 40,000 doses are reported to have been used. 
Approximately 100 adverse events have been reported to date, including 66 reports of recumbency (involving 98 animals) and 17 reports (involving 22 animals) involved death or euthanasia of the treated cows. Many of the adverse events reported occurred in Denmark.
It is 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.

Background Information Or Related Documents:
The MAH is investigating the reported adverse events and further advice may be available in due course. Further information can also be found on the EMA website.  

Actions To Be Taken:
The product has not yet been launched in Ireland, however should this situation change in the future, veterinarians should ensure that the product is used in compliance with the approved product information. 
Contrary to normal practice in drying off cows, the MAH 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). A best practice guide for dry-off when using Velactis is also available from the MAH. 
As with the use of any other veterinary medicinal product, any future adverse events that may be observed following use of Velactis should be promptly reported to the HPRA or the Marketing Authorisation Holder at the earliest opportunity.

Further Information:
The EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has started an urgent review of this new safety 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.

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