ADVERSE REACTIONS
 

CURRENT ISSUES

 

VMD statement on Pregsure BVD – Updated 22 July 2010

Bovine neonatal pancytopenia (BNP), also known as ‘bleeding calf syndrome’, is a new emerging disease affecting calves from birth to 4 weeks of age at the start of the clinical signs. It is characterised by spontaneous and prolonged bleeding from orifices or wounds and also from apparently intact skin. Fever and severe anaemia are frequently reported and the outcome is death in nearly all cases. A minority of calves die rapidly with few or no obvious clinical signs. A pathological change in the bone marrow is a consistent post mortem finding.

On 3 June 2010 Pfizer Animal Health, the Marketing Authorisation Holder for Pregsure BVD (inactivated Bovine Viral Diarrhoea (BVD) type 1 virus), voluntarily stopped selling Pregsure BVD in all EU Member States, including the UK, in order to assist the company and other investigators in understanding the aetiology of the disease and to facilitate the monitoring of its epidemiology. Pfizer took this action as a result of an increased incidence of suspected adverse reactions in calves from vaccinated dams, specifically involving BNP.

The matter was notified to the European Committee for Medicinal Products for Veterinary Use (CVMP) by Germany under Article 78 of Directive 2001/82/EC, due to concerns relating to animal safety following the use of the vaccine in dams and the development of BNP in calves. The Committee concluded the procedure for Pregsure BVD during its meeting held on 13-15 July 2010. The Committee reviewed pharmacovigilance data, as well as epidemiological and laboratory data, and, although the aetiology of the disorder remains obscure at present and the associated risk factors have yet to be determined, the Committee considered that the information available is sufficient to indicate a potential association with the product. Therefore, the Committee adopted by majority an opinion concluding that the Marketing Authorisation for Pregsure BVD should be suspended until scientific evidence is available to demonstrate that the administration of the vaccine to dams according to authorised conditions of use does not lead to an increased risk of BNP or that risk mitigation measures ensuring the safe use of the product can be implemented. In addition, the Committee recommended that all batches of the product be recalled at wholesale level.

Defra will continue to work in collaboration with other research institutes and Pfizer to better understand the nature of this emerging disease. The VMD will continue to record and monitor cases of BNP reported as suspected adverse reactions.

Bluetongue virus vaccine field safety data

The EMEA’s Committee for Medicinal Products for Veterinary Use (CVMP)  has reviewed data provided by Member States regarding the safety of Bluetongue vaccines used during 2008 as part of the Community approved emergency vaccination campaigns to immunise cattle and sheep.  Overall, the frequency of adverse drug reactions was very low (<1:10,000) and the results support the continued use of inactivated bluetongue vaccines in the 2009 vaccination campaign.

The press release and the report can be reached by following these links:

Press release: http://www.emea.europa.eu/pdfs/general/direct/pr/5679409en.pdf

Report: http://www.emea.europa.eu/pdfs/vet/press/pos/65201908en.pdf

Risk of avermectin toxicity to dogs

Horse, cattle and sheep wormers containing avermectins (eprinomectin, ivermectin, moxidectin or doramectin) present a serious risk of poisoning to dogs. In dogs, these drugs can cause nervous signs such as depression, pupil dilation, blindness, fits, staggering, coma and death. Collies and Collie-mix dogs are known to be particularly at risk as these animals are more sensitive to the effects of this drug class. Tortoises and turtles are also at risk.

The majority of cases of such poisonings in dogs reported to the VMD occurred because the dog ate spilt worming paste or horse feed containing these drugs, but there have been cases of dogs that fell ill after playing with used syringes. Not only pastes but also injectable and pour-on solutions are dangerous to dogs and contact with, or swallowing even small amounts of product may cause serious clinical signs.

The package leaflets of wormers containing eprinomectin, ivermectin, moxidectin or doramectin contain warnings regarding avermectin toxicity. It is important that users of these products read the instructions carefully before dosing their animals. It is also important that spillages are avoided and used syringes and containers are disposed of safely. Dogs suspected of having ingested or been in direct contact with products containing these drugs should be taken to their veterinarians as soon as possible.

Any suspected cases of avermectin poisoning should be reported to the VMD using the Yellow Form. Details of how to report a suspected adverse reaction and Yellow Forms can be found by following the link http://www.vmd.gov.uk/General/Adverse/adverse.htm.

Permethrin Spot On Products Can Kill Cats

The following spot on products can be deadly for cats:

Advantix Spot On Solution for Dogs
Armitage Pet Care Flea and Tick Drops for Dogs 702mg Spot-on Solution
Beaphar Dog Flea and Tick Drops, 65% w/w, Cutaneous Solution
Bio-tech’s Anti-Flea and Anti-Tick Drops for Dogs
Bio-tech’s Flea and Tick Drops for Dogs
Bob Martin Dog Spot On Solution 744mg
Bob Martin Dog Spot On Solution 1488mg
Bob Martin Flea and Tick Spot On Solution 744mg
Bob Martin Permethrin Dog Spot On
Exspot Insecticide for Dogs
Hartz Control Pet Care System One Spot Flea and Tick Remedy for Dogs
Hyperdrug Veterinary Flea and Tick Drops for Dogs 742mg Cutaneous Solution
Johnson’s Flea and Tick Drops 742mg for Puppies and Small Dogs, Cutaneous Solution
Johnson’s Insecticidal Flea and Tick Drops 742mg, Cutaneous Solution
Protect Spot Flea and Tick Drops for Dogs
Wilko Dog Flea Drops 65% w/w Cutaneous Solution

These products are intended for the treatment of fleas and ticks in dogs only. They contain permethrin, a substance that is safe for dogs but causes a toxic reaction in cats when present in spot on products, due to its concentration. Cats treated with even small amounts of spot on products containing permethrin, or allowed to groom dogs treated with any of the products in the list above, can develop nervous signs such as depression, drooling, tremors, seizures, vomiting and staggering, and can die.  

Some pet owners apply spot on products containing permethrin that are indicated for use in dogs to their cats by mistake, or because they think that it is safe if they use only small amounts of the product. It is not safe to use any spot on product containing permethrin in cats. If you have applied any of the products listed above to your cat, it is important to wash off the product from the cat with water and a mild detergent and seek immediate treatment from your veterinary surgeon. Take the product package with you and show it to the veterinarian.

The VMD is actively monitoring the incidence of suspected adverse reactions to these products and requests that any incident be reported as soon as possible. Details of how to report a suspected adverse reaction can be found by following the link http://www.vmd.gov.uk/General/Adverse/mal252.pdf.

Injection site fibrosarcoma

The EMEA has prepared an advisory notice to veterinary surgeons regarding the development of injection site sarcoma in cats. The press release and the advisory notice can be reached by following this link: http://www.emea.europa.eu/pdfs/vet/press/pr/29627907en.pdf.
 

Harmonisation of PSUR Submission Dates

There is a European initiative to harmonise the European Birth Dates of veterinary medicinal products with the same active substances.  The aim is to synchronise the dates of submission of Periodic Safety Update Reports (PSURs) for related products.  The VMD is always willing to consider requests from marketing authorisation (MA) holders to amend the periods covered by individual PSURs, providing that the overall frequency of these reports respects the schedule set out in Article 75(7) of Directive 2001/82/EC, and that the MA holder describes how the transition will be managed to avoid gaps or overlaps in the data.  For further information please contact Fabia Dyer - phone 01932 338424 or e-mail f.dyer@vmd.defra.gsi.gov.uk

Correct Use of Intramammary Treatments

It is essential that strict aseptic techniques are used for the infusion of intramammary treatments authorised for use at drying off, particularly those which possess no antimicrobial activity.   Care must be taken not to introduce pathogens into the teat, as the failure to do so can lead to serious, possibly fatal, cases of post-infusion mastitis.

Cows should be prepared and treated on an individual cow basis as a separate job and not during milking or foot trimming.  

Animals must be appropriately restrained in hygienic conditions – a foot crush would not be appropriate.

Ensure that adequate supplies of clean, dry cotton wool and surgical spirit (or the equivalent) are available before starting the process, as it has been demonstrated that swabs freshly prepared from these are the most effective means of teat cleaning.

Keep intramammary syringes clean and DO NOT immerse in water.

Wear a separate pair of clean, disposable gloves for each cow.

Start with a visibly clean, dry teat and udder.  If the teats are obviously dirty, clean the dirt from them with moistened disposable paper towels, avoiding getting the udder wet.  Then wipe each teat completely dry with separate disposable paper towels and change gloves.  Dip the teats in a rapid-acting pre-dip, leave for 30 seconds, then wipe each teat completely dry with separate disposable paper towels.  Strip the fore milk (3 - 4 draws) into a strip cup and discard.

Thoroughly disinfect the whole surface of the teat with a disposable swab made from clean, dry cotton wool soaked in surgical spirit.  Clean the teats furthest away from you first, to avoid contaminating clean teats.

Using a new, disposable surgical spirit swab individually prepared for each teat, gently scrub the teat end.  Use fresh swabs, if necessary, until both the teat end and swab are clean.  Clean the teats furthest away from you first, to avoid contaminating clean teats.

Remove the cap from the intramammary tube, being careful not to touch the nozzle.  If you do touch the nozzle by mistake, do not use the tube and discard it.  Infuse the contents of the syringe into the teat avoiding contaminating the teat end.  Tube teats in the opposite order to cleaning, i.e. infuse the quarters closest to you first. 

Apply a post-milking teat disinfectant and confine the treated cows to a loafing yard so that they must stand for at least 30 minutes to allow the teat canal to close.

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