VMD responds to Librela solution concerns
The drug affects fewer than 15 animals for every 10,000 doses sold.
The Veterinary Medicines Directorate (VMD) has said that it is ‘constantly reviewing’ Librela Solution for Injection for Dogs, following media reports of adverse events.
The medicinal product, which contains the active substance bedinvetmab, is used for the alleviation of pain caused by osteoarthritis in dogs.
Reports in the media, particularly in the United States of America, throughout 2024 had revealed concerns about adverse effects from the drug. The Food and Drug Administration (FDA) released a statement in December describing severe side effects from the popular drug.
As part of its drug authorisation process, the VMD assesses the safety, quality and efficacy of veterinary medicines before and after authorisation.
Based on findings from recent reports, the VMD updated the Summary of Product Characteristics (SPC) for Librela Solution on 10 December 2024.
The new data reveals that, in rare cases, diarrhoea, emesis, ataxia, urinary incontinence, anorexia and lethargy have been reported. In very rare cases, some dogs have experienced seizures.
Previously recorded adverse events include hypersensitivity reactions, immune-mediated haemolytic anaemia and immune-mediated thrombocytopenia.
The VMD says that any instances of a suspected adverse event are monitored by its pharmacovigilance team. The team assesses reports submitted to the VMD from both veterinary professionals and animal owners.
As with all medicinal products marketed in the UK, the pharmacovigilance team had been continuously monitoring Librela since it was first released in November 2020.
The VMD states that no medicinal product is 100 per cent risk free. It calculates that, according to its data, fewer than 15 animals experience adverse events for every 10,000 doses of Librela sold.
It tells veterinary professionals and pet owners that it is constantly reviewing adverse event report data for authorised medicines. This means that, for each licensed veterinary product, the benefits of the medicine must outweigh the risks posed by potential adverse events.
To report any adverse effects for a drug, find the Marketing Authorisation Holder’s contact details in the product information or find the product on the Product Information Database. Further information about the Librela Solution for Injection in Dogs can be found here.
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