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1313618
registered interest false more like this
date less than 2021-05-11more like thismore than 2021-05-11
answering body
Department for Environment, Food and Rural Affairs more like this
answering dept id 13 more like this
answering dept short name Environment, Food and Rural Affairs more like this
answering dept sort name Environment, Food and Rural Affairs more like this
hansard heading Cats: Meloxicam remove filter
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty's Government, further to the US Food and Drug Administration including boxed warning labels on Metacam (Meloxicam) due to the risks associated with acute renal failure and death in cats, what steps they are taking to ensure similar warnings are in place on all boxes of Metacam sold to vets in the UK. more like this
tabling member printed
Lord Blencathra more like this
uin HL10 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2021-05-25more like thismore than 2021-05-25
answer text <p>There are three Metacam products authorised for use in cats in the UK:</p><p> </p><p>- Metacam 5 mg/ml solution for injection for dogs and cats</p><p>- Metacam 2mg/ml solution for injection for cats</p><p>- Metacam 0.5 mg/ml oral suspension for cats and guinea pigs</p><p> </p><p>All three products already include warnings relating to renal failure and therefore veterinary surgeons in the UK are aware of the risk of renal failure with the use of Metacam in cats.</p><p> </p><p>In 2019, the marketing authorisation holder for Metacam was requested to provide an analysis of all cases of renal failure and death in cats. The company provided data comparing the use of the product and the frequency of cases in the United States (US) with those in the EU. This demonstrated a significantly higher incidence of off-label use (use of the product not in accordance with the product information), renal failure and fatalities in the US compared with the EU. Vets are allowed to use veterinary medicinal products off-label in certain circumstances. However, the Metacam data does not indicate that the incidence of such use is as prevalent in the EU or the UK as in the US. It was concluded that vets in the EU and UK were already aware of the risks of renal failure with off-label use and the product information included sufficient warnings relating to the correct use and associated risks. The company was requested to continue specifically to monitor cases of renal failure in cats.</p><p> </p><p>Based on a review of the data over the past 10 years, the incidence of renal failure in the UK following use of Metacam in cats has gradually decreased from one in 200,000 to one in a million, supporting the view that vets are now even more aware of the risks associated with off-label use.</p><p> </p><p>The Veterinary Medicines Directorate will continue to consider the scientific evidence to inform further action as required and the consistency of product information and warnings for all meloxicam products.</p>
answering member printed Lord Benyon more like this
grouped question UIN HL11 more like this
question first answered
less than 2021-05-25T14:28:37.663Zmore like thismore than 2021-05-25T14:28:37.663Z
answering member
1547
label Biography information for Lord Benyon more like this
tabling member
497
label Biography information for Lord Blencathra remove filter
1313619
registered interest false more like this
date less than 2021-05-11more like thismore than 2021-05-11
answering body
Department for Environment, Food and Rural Affairs more like this
answering dept id 13 more like this
answering dept short name Environment, Food and Rural Affairs more like this
answering dept sort name Environment, Food and Rural Affairs more like this
hansard heading Cats: Meloxicam remove filter
house id 2 more like this
legislature
25277
pref label House of Lords more like this
question text To ask Her Majesty's Government what steps the Veterinary Medicines Directorate are taking to draw to the attention of veterinary surgeons the acute dangers to cats of a repeat injection dose of Metacam (Meloxicam). more like this
tabling member printed
Lord Blencathra more like this
uin HL11 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2021-05-25more like thismore than 2021-05-25
answer text <p>There are three Metacam products authorised for use in cats in the UK:</p><p> </p><p>- Metacam 5 mg/ml solution for injection for dogs and cats</p><p>- Metacam 2mg/ml solution for injection for cats</p><p>- Metacam 0.5 mg/ml oral suspension for cats and guinea pigs</p><p> </p><p>All three products already include warnings relating to renal failure and therefore veterinary surgeons in the UK are aware of the risk of renal failure with the use of Metacam in cats.</p><p> </p><p>In 2019, the marketing authorisation holder for Metacam was requested to provide an analysis of all cases of renal failure and death in cats. The company provided data comparing the use of the product and the frequency of cases in the United States (US) with those in the EU. This demonstrated a significantly higher incidence of off-label use (use of the product not in accordance with the product information), renal failure and fatalities in the US compared with the EU. Vets are allowed to use veterinary medicinal products off-label in certain circumstances. However, the Metacam data does not indicate that the incidence of such use is as prevalent in the EU or the UK as in the US. It was concluded that vets in the EU and UK were already aware of the risks of renal failure with off-label use and the product information included sufficient warnings relating to the correct use and associated risks. The company was requested to continue specifically to monitor cases of renal failure in cats.</p><p> </p><p>Based on a review of the data over the past 10 years, the incidence of renal failure in the UK following use of Metacam in cats has gradually decreased from one in 200,000 to one in a million, supporting the view that vets are now even more aware of the risks associated with off-label use.</p><p> </p><p>The Veterinary Medicines Directorate will continue to consider the scientific evidence to inform further action as required and the consistency of product information and warnings for all meloxicam products.</p>
answering member printed Lord Benyon more like this
grouped question UIN HL10 more like this
question first answered
less than 2021-05-25T14:28:37.74Zmore like thismore than 2021-05-25T14:28:37.74Z
answering member
1547
label Biography information for Lord Benyon more like this
tabling member
497
label Biography information for Lord Blencathra remove filter