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Suspension of Veterinary Medicines containing the excipient Diethanolamine (DEA)

The VMD suspended products for food-producing animals that contain diethanolamine (DEA).

VMD

The VMD is not recalling products. The VMD judges the consumer safety risk to be very low and we are not aware of any problems in animals associated with the use of products containing DEA.

Any existing stocks can continue to be used until they run out. Vets may continue to prescribe and use products containing DEA while stock is available. Vets may also continue to obtain stock for non-food horses from wholesalers.

Availability of flunixin for intravenous use in non-food producing horses

The VMD is aware of vets’ concerns over the potential future lack of availability of flunixin (which contains DEA) for intravenous use in non-food producing horses.

The VMD has agreed with Marketing Authorisation Holders that currently labelled products containing flunixin, such as Finadyne, can be released onto the market for non-food horses only, provided they are accompanied by a “Caution in Use” letter (as approved by the VMD) which outlines the conditions of use and restricts supply to non-food horses.

The VMD will work closely with companies who wish to reformulate their products to remove DEA so that their products can be placed back on the market.

Availability of alternative medicines

Eight of the nine suspended products are solutions for injection for cattle and horses or cattle, horses and pigs containing flunixin meglumine, a non-steroidal anti-inflammatory drug. The other suspended product is a suspension for injection for cattle, horses and pigs containing the antimicrobials trimethoprim and sulfadiazine.

There are other veterinary medicines currently authorised for use in cattle, pigs and horses that either contain the same active substance(s) in a different form or can be used to treat the same conditions.

Treatment decisions are the responsibility of the individual prescribing vet.

A list of the suspended products is below:

Product Vm Number MAH
Allevinix 50 mg/ml Solution for Injection for Cattle, Pigs and Horses 15052/4144 Ceva Animal Health Ltd
Cronyxin Injection, 5% w/v Solution for Injection 12597/4014 Cross Vetpharm Group Ltd
Dugnixon 50 mg/ml Solution for Injection for Cattle, Pigs and Horses 36167/4005 Global Vet Health S.L.
Finadyne 50 mg/ml Solution for Injection 01708/4582 Intervet UK Ltd
Flunixin 50 mg/ml Solution for Injection for Cattle, Horses and Pigs 02000/4170 Norbrook Laboratories Limited
Meflosyl 5% Solution for Injection 42058/4085 Zoetis UK Limited
Norixin 5% Solution for Injection 02000/4137 Norbrook Laboratories Limited
Pyroflam 50 mg/ml Solution for Injection for Cattle, Horses and Pigs 02000/4253 Norbrook Laboratories Limited
Tribrissen 48% Suspension for Injection 01708/4593 Intervet UK Ltd

Reason for the suspension

The VMD has done this in the light of the scientific opinion of the Committee for Medicinal Products for Veterinary Use (the scientific advisory committee to the European Medicines Agency) that there may be a risk to humans from consuming food from animals treated with products containing DEA.

Published 26 July 2018
Last updated 13 August 2018 + show all updates
  1. Update on supply, further batches released
  2. Update regarding supply
  3. Updated 1 August 2:30pm
  4. Updated
  5. First published.