Safety of Cartrophen Vet in the dog: review of adverse reaction reports in the UK |
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| Authors: | Hannon R L Smith J G Cullis-Hill D Ghosh P Cawdery M J Hope |
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| Institution: | Biopharm Australia Pty, 111 Bronte Road, Bondi Junction, NSW 2022, Australia. |
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| Abstract: | Suspected adverse reactions (SARs) reported for Cartrophen Vet (100 mg sodium pentosan polysulphate/ml) to the Veterinary Medicines Directorate in the UK for the period January 1991 to October 1999 were reviewed. Of the 161 reports, 28 were probably product related, 54 were possibly product related, 71 were unlikely to be related and eight were unclassified. An estimated real incidence of adverse reactions probably and possibly associated with Cartrophen Vet of 0.074 per cent on an individual dose basis was calculated (assuming only 10 per cent were documented due to underreporting). Sixty-two SARs (38.5 per cent) documented emesis, 22 (35.5 per cent) of which were product related (onset five to 15 minutes after administration). Sixty-eight SARs (42.2 per cent) documented general changes to demeanour, 10 (14.7 per cent) were product related (lethargy and/or mild depression and/or mild inappetence lasting up to two days after administration). Six SARs were considered likely to be associated with concurrently administered carprofen. Cartrophen Vet had a low incidence of side effects that were mild and transitory. |
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