Rise in Augmentin adverse reaction reports
GlaxoSmithKline said that it has not altered the manufacture of the product and it is not aware of any batch defects.
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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