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1. FOI2025/00174 Request

Itchiness is not listed in the side effects lists for Incurin. I would like to know if there are more animals suffering this or if this has been reported as a side effect?

2. Our reply

Incurin 1mg tablets is a veterinary medicinal product (VMP) used for the treatment of hormone dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised dogs.

If you or someone else involved with the case has not yet reported this adverse event to the relevant Marketing Authorisation Holder (MAH, pharmaceutical company) then please do so. MAH contact details can be found within the product information that comes packaged with a medicine, on the MAH’s website, or by searching for the product on the , which contains details of all authorised VMPs. The MAH for Incurin is MSD Animal Health and their adverse event reporting form can be found .ÌýÌýÌý

MAHs have a legal obligation to report all adverse event reports they receive to the VMD within 30 days of awareness, as per paragraph 57 of  and the accompanying guidance in Guideline III Adverse event reporting - °Ç¸ç³Ô¹Ï.ÌýÌýÌý 

All adverse events submitted to the VMD have their clinical signs coded using the  (VeDDRA). We have provided you below with the number of adverse event reports for Incurin 1mg tablets for pruritus by preferred term (PT), which is one of the hierarchical levels of VeDDRA. Further information regarding VeDDRA can be located on the , including the VeDDRA list of clinical terms for reporting suspected adverse events and the Guidance notes on the use of VeDDRA terminology.ÌýÌýÌý 

Your request pertained to itching of the skin, specifically questioning if this has been encountered before following administration of Incurin. In our database, there are 24 cases for Incurin that include the PT pruritus in the United Kingdom.

Please be aware the data are not subject to independent verification and the VMD does not guarantee their accuracy. The figures are based on adverse events submitted to the VMD for the purposes of pharmacovigilance.ÌýÌýÌý 

We have included all adverse event reports. This includes reports where more than one product was used, reports when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, or reports where, on further evaluation, there may have been other reasons for the adverse event occurring.ÌýÌýÌý 

Evaluation is dependent on the accuracy and quality of data received from veterinary professionals and animal owners, and reporting frequency can vary over time (reporting frequency may be affected by a product being new to the market or social media interest, for example).ÌýÌýÌý

Although adverse event report information can be useful to provide a general overview of a VMP, it is important for any clinical decisions regarding the use of a VMP to be based on a risk-benefit discussion specific to the animal or group of animals being administered the VMP. An overall frequency of an adverse event occurring for a VMP does not reflect the actual risk for an individual animal, as there are many individual factors that may contribute to the likelihood of an adverse event occurring.ÌýÌýÌý

All medicines whether for human or animal use come with risk, and the benefits of use in wider populations need to outweigh the potential risks. Information on adverse events that have been known to occur following administration of a particular product are summarised in sections 3.6/4.6 of the Summary of Product Characteristics (SPC).  The SPC is a document describing the properties and the officially approved conditions of use of a medicine. The SPC and associated product information are updated as new information is available, and the latest version of an SPC can be found on our publicly available . We continually assess and update our findings relating to products used within the United Kingdom and should there be sufficient data to suggest that an SPC requires alteration or that another appropriate action is required, this will be carried out within the required timeframe, as set out by the current legislation surrounding that veterinary medicinal product or region.ÌýÌýÌý 

Pharmacovigilance updates are published on gov.uk at /guidance/urgent-safety-updates-for-veterinary-medicines; this also includes any updates involving non-veterinary medicines used in animals. To receive these pharmacovigilance updates via email, please click on the ‘Get emails about this page’ button.