Marketing authorisation for medicine for cows suspended in the EU/EEA
On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.
The suspension of Velactis means that as from 14 July 2016, it is no longer permitted to use Velactis in the EU/EEA.
Following discussions in the CVMP, the European Commission asked the CVMP on 16 June 2016 to assess the benefits and risks of Velactis on the basis of the reported adverse reactions. On 21 June 2016, the Danish Medicines Agency decided to suspend the use of Velactis in Denmark based on serious adverse reaction reports received.
On 14 July 2016, the CVMP agreed unanimously to recommend to the European Commission that the marketing authorisation for Velactis be suspended temporarily and any distributed medicine be recalled in all links. The CVMP recommendations do not include cabergoline for pets or humans.
The background for suspending Velactis
From 21 March to 12 July 2016, a total of 198 adverse reaction reports were submitted after treatment with Velactis (EU/EEA, Brazil and Mexico) – related to events in 319 animals, 71 of which died or had to be put down. 135 of these reports, with 208 responding animals, were related to cows being unable to stand (recumbency) and 57 of the animals died.
The underlying mechanisms remain unresolved. There are several theories that e.g. management (feeding the animals before drying off and moving the animals in connection with drying off), race, yield at the time of drying off etc. may play a role, but the impact of the individual factors are yet to be determined. At present, there are no clear recommendations ensuring that the use of the medicine will not cause further adverse reactions.
The suspension of Velactis may be lifted on condition that the marketing authorisation holder resolves the underlying mechanisms and changes the summary of product characteristics so that risks are reduced or avoided.
Information for users
- Velactis is used as an aid in the abrupt drying-off in dairy cows and has been linked to a relatively large number of reports of serious adverse events, including deaths.
- As a result of the serious adverse reaction reports, the authorisation of Velactis is being suspended temporarily.
- Users are advised to stop using Velactis in dairy cows and use alternative methods for drying off.
- Users must return the medicinal product in accordance with the usual recall procedures.
- If you have any questions to the above, please contact your veterinarian, the Danish Veterinary and Food Administration or the Danish Medicines Agency.
Facts about Velactis
Velactis contains the active substance cabergoline.
The medicine is used at drying off (discontinuation of milk production) in dairy cows and helps to reduce milk production, discomfort and milk leakage at drying off, and the risk of infections of the udder during the dry period is also reduced.