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Rise in Augmentin adverse reaction reports
medical
GlaxoSmithKline said that it has not altered the manufacture of the product and it is not aware of any batch defects.
Practices encouraged to report all adverse events to the VMD

There has been a significant rise is the number of adverse reaction reports relating to Augmentin Intravenous Powder for Solution for Injection, according to the Veterinary Medicines Directorate (VMD).

In a letter to Veterinary Record (Vol. 176, No. 23) Gillian Diesel from the VMD said that over the past three months, the organisation has seen a 'significantly higher' number of reports relating to Augmentin.

"They all involved hypersensitivity reactions, including allergic oedema, urticaria and allergic pruritus," writes Gillian.

"We notified veterinary practices of a similar issue in 2011 concerning Co-amoxiclav, which also contains amoxicillin and clavulanate."

Augmentin is authorised for use in humans and is authorised for use by veterinary surgeons under the cascade system. It is not authorised for use in animals, so no safety or efficacy studies have been carried out relating to its use in animals.

The VMD spoke to the manufacturer, GlaxoSmithKline and the Medicines and Healthcare Products Regulator Agency (MHRA).

GlaxoSmithKline said that it has not altered the manufacture of the product and is not aware of any batch defects. They asked some practices to send them samples of a batch for testing, which confirmed that the product was within manufacturing specifications.

GlaxoSmithKline and the MHRA also said they were not aware of a rise in the number of reactions or reports from humans relating to the product.

"We would like to encourage practices to report all adverse events to the VMD using our online reporting form," added Gillian.

"As Augmentin is not authorised for use in animals, GlaxoSmithKline has no obligation to investigate these case or report them to the VMD.

"We would also like to remind vets that any human adverse reactions to authorised human medicines should be report to the MHRA."

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Defra shares new Sanitary and Phytosanitary guidance

News Story 1
 Defra has published guidance for the vet sector ahead of a proposed UK-EU Sanitary and Phytosanitary agreement.

The agreement, which will change the movement and trade of animals and related products, could see reductions in checks, paperwork and certification. As well as describing regulatory developments, the advice highlights the importance of animal ID, registration and traceability in disease control and other compliance arrangements.

The guidance can be found here. More detail is expected as negotiations progress. 

Click here for more...
News Shorts
New form for online veterinary medicines retailers

The Veterinary Medicines Directorate (VMD) has produced a new online form for retailers wishing to sell veterinary medicines on the internet.

The form replace the previous Word version and is part of the VMD's ongoing commitment to digitise its processes. Anyone retailing prescription medicines online, including POM-V, POM-VPS and NFA-VPS categories, is lawfully required to register with the VMD before trading.

The change only applies to new applicants. Retailers already listed on the VMD's Register of Online Retailers or registered under the Accredited Internet Retailer Scheme (AIRS) do not need to do anything.