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Suspension of Veterinary Medicines containing the excipient Diethanolamine (DEA)

The VMD has suspended products for food-producing animals that contain the excipient diethanolamine (DEA) - updated 13 August.

VMD

Update 13 August

Further flunixin product is now available to order.

Wholesalers can accept further batches from the manufacturer provided it is accompanied by a “Caution in Use” letter.

Update 9 August

The VMD is actively working with Marketing Authorisation Holders to allow them to release further currently labelled flunixin product onto the market for non-food horses only, provided it is accompanied by a “Caution in Use” letter (to be approved by the VMD) which outlines the conditions of use and restricts supply to non-food horses. We will inform vets when flunixin product is available to order.

Update 1 August 2018 2:30pm

The suspension means that no product containing DEA and indicated for a food-producing animal may be released or placed on the market by the Marketing Authorisation Holder. No products are being recalled. 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.

Distribution of products containing DEA

At this stage, no further product may be released by the qualified person or placed on the market (i.e. stock controlled by Marketing Authorisation Holders may not be sent to wholesalers). However, as the products are not being recalled, products already at the wholesalers may continue to be distributed.

Using products containing DEA

Vets may continue to prescribe and use products containing DEA whilst stock is available.

Vets may also continue to obtain stock from wholesalers. Therefore there should not be any immediate availability concerns.

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.

Future 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 for intravenous use in non-food producing horses. The VMD is investigating potential ways to maintain the availability of injectable flunixin for use in such horses.

A list of these 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

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.