Velactis - *Now suspended*

llamedos

New Member
EMA reviewing veterinary medicine Velactis
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. 100adverse 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. TheCVMP 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 theadverse 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.

Credit EMA
 

jade35

Member
Location
S E Cornwall
Thank you @llamedos, quite a lot of advertising for Velactis at the moment and our vets are (maybe were now) having a meeting next week having trialled it on some local farms over the last few months. Iirc it is in the region of £15/dose and recommendation is for cows giving over 20 litres/day at drying off.
 
I have bought one bottle to try, thinking it might help in the aim towards targeted rather than blanket DC therapy.
£15 / dose is what I paid.
So far no issues. However I did expect the effect to be more marked. ( I would say it helped a bit, rather than a lot )
Given that, and the potential problems highlighted above , big question mark for me.
 
Speaking to my vet about it, he said the majority of the problems were in Denmark where milk fever at drying off is not unheard of because some farms restrict water to help off.

Misuse then.
Perhaps I will finish my bottle off after all.
That's the kind of practice the promoters of Velactis are wanting to replace. On welfare grounds.
 

Clay52

Member
Location
Outer Space
The whole getting a cow to produce more and more milk and then needing more and more artifical ways to make her produce then stop her producing!
The fact you have to drug a cow to dry her off now is plain barmy to me.

Well an ideal cow will still be producing well when i have to dry her off. It's a good problem to have in my opinion. Each batch to dry off we end up with a fair few cows over 30 and some near 40lt. That's what I want.

Cut their grain off and it's enough that late in lactiation to drop them pretty quick, even if they weren't getting much grain anyway.
 

Sid

Member
Livestock Farmer
Location
South Molton
And of course you should buy organic or free range milk because none of these cows are given drugs to stop over production of milk at the end of their lactation.

I'm sorry but sometimes the intensive conventional milk industry causes its own misfortune
 

Clay52

Member
Location
Outer Space
And of course you should buy organic or free range milk because none of these cows are given drugs to stop over production of milk at the end of their lactation.

I'm sorry but sometimes the intensive conventional milk industry causes its own misfortune

Please get off the high horse and don't act like every conventional cow is given injections to dry them up. This is the first I've even heard of it.

And why try and turn this into an organic debate.
 

Sid

Member
Livestock Farmer
Location
South Molton
Please get off the high horse and don't act like every conventional cow is given injections to dry them up. This is the first I've even heard of it.

And why try and turn this into an organic debate.

I said free range and organic.
I didn't say all of them were try reading properly!

I was making the point that the conventional industry is going down the lower antibiotics route but then another stick to beat them turns up. Isn't it better to not use it if at all possible?

Put cows in a paddock with just water and belly fill for a week pre drying off?
 

Clay52

Member
Location
Outer Space
I said free range and organic.
I didn't say all of them were try reading properly!

I was making the point that the conventional industry is going down the lower antibiotics route but then another stick to beat them turns up. Isn't it better to not use it if at all possible?

Put cows in a paddock with just water and belly fill for a week pre drying off?

And most people have never used or even heard of this injection for drying off their cows anyway. Just relax.

But if it works well with no complications and results better welfare for the animal. What's wrong with it.
 
Speaking as perhaps one of a minority who are trying it, I certainly am not trying to slow down cows that I have artificially forced into producing unnatural amounts of milk. Typically , 7.5- 8.5 k litre cows getting very little concentrate at the end of lactation. But nonetheless, cows with a natural willingness to keep going. The aim is to reduce udder engorgement and reduce / stop teat leakage in known candidates. DC therapy over many years, and like many farmers has enabled me to consistently deliver the quality milk the market demands. The emphasis is now starting to shift, and I recognise I need to shift with it. Teat sealants are part of the picture, but ( I feel ) they need an aid to deliver the same quality of result. So I am trying this.
The paddock + bellyfill scenario might work for some cows, but for others that are otherwise unprotected it would be a mastitis / summer mastitis
generating exercise.
 
Last edited:

llamedos

New Member
suspension of velactis following adverse events in dairy cattle


Veterinary Medicines Directorate (VMD) has suspended the use of the veterinary medicine Velactis used in dairy cows at the time of drying off following reports of serious adverse events in cows, including recumbency and deaths


Summary

· Velactis is used as an aid in the abrupt drying-off in dairy cows and has been linked to several cases of recumbency and deaths.

· As a result of the serious cases, the authorisation of Velactis is being suspended.

· Users are advised to stop using Velactis in dairy cows and use alternative methods for dry off.

· Users who have any questions should contact their veterinarian or national veterinary medicines authority.


Background

1. The VMD has suspended the marketing and use of Velactis in the UK.

2. This prescription only veterinary medicine, marketed by CEVA Sante Animale, the Marketing Authorisation Holder (MAH) contains the active substance cabergoline, and is used in the herd management programme of dairy cows as an aid in abrupt drying-off, by reducing milk production.

3. The product was authorised through the European Medicines Agency (EMA) in December 2015 and was first sold in the UK in April 2016.

4. The withdrawal follows reports of adverse events in 319 dairy cows after treatment with Velactis. Many of the adverse events were serious, including recumbency (lying down and being unable to stand) in 208 animals, which generally occurred within 24 hours of administering Velactis. In total, there were 71 reported deaths in cows, most after a period of recumbency.

5. Anecdotal evidence suggests that hypocalcaemia treatments may be successful in reversing clinical signs.

6. Although the exact cause of these adverse events is yet to be determined, there is evidence to suggest that 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 European Medicines Agency (EMA) concluded that, at present, the risks outweigh the benefits of the product.

7. CEVA Sante Animale stopped further distribution of the product in Europe last month pending the outcome of an (urgent) review by the EU’s scientific committee, The Committee for Medicinal Products for Veterinary Use (CVMP). The CVMP has now advised the European Commission to suspend the authorisation of Velactis and to order Ceva Sante Animale to recall the product from the supply chain pending the outcome of further investigations to assess a possible causal link between the product and the adverse events reported. The nature and use of the product means that there is no risk to human health or consumer safety.

8. The use of Velactis in the UK is now suspended.

9. CEVA Sante Animale has initiated a voluntary product recall.

10.We strongly encourage vets and farmers to submit to the VMD any outstanding reports of adverse events associated with use of Velactis using our online reporting form or directly to CEVA Sante Animale for further investigation by the MAH as necessary.
 

Sid

Member
Livestock Farmer
Location
South Molton
And most people have never used or even heard of this injection for drying off their cows anyway. Just relax.

But if it works well with no complications and results better welfare for the animal. What's wrong with it.
Are you still going to use it? It great stuff look!

Can't all be the farmers fault like some were saying it was.
 

NI agri-food stakeholder groups discuss climate change bill with committee

  • 32
  • 0
Written by Richard Halleron from Agriland

The Livestock and Meat Commission (LMC) recently submitted oral evidence to members of the Stormont Agriculture, Environment and Rural Affairs (AERA) committee on the content and potential impact of the Northern Ireland Climate Change Bill (No.2).

This draft legislation was recently introduced to the Northern Ireland Assembly by the Department of Agriculture, Environment and Rural Affairs (DAERA) in conjunction with agriculture minister, Edwin Poots.

“We were accompanied by representatives from a wide range of food industry bodies, including the Northern Ireland Meat Exporters’ Association,the Ulster Farmers’ Union [UFU], Northern...
Top