Freedom of Information request (FOI 22/915)
Published 17 January 2024
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FOI 22/915
6th September 2022
Dear
Thank you for contacting the MHRA and requesting evidence that a serious side effect of alogliptin is Fournier’s gangrene (necrotising fasciitis) as stated on the NHS Side effects of alogliptin page.
You may be interested to know that the product information for alogliptin products is available here. Fournier’s gangrene is not currently listed in the product information as a possible side effect of alogliptin. Alogliptin is used to treat type 2 diabetes in adults. It belongs to a group of medicines called DPP-4 inhibitors.
The MHRA publishes information on the suspected side effects being reported to the MHRA via the Yellow Card scheme in the form of interactive Drug Analysis Profiles (iDAPs). There is an iDAP for each licensed medicine by drug substance. Within an iDAP you can see all suspected side effects, known as suspected adverse drug reactions, that are reported to the MHRA. Up to and including 22/08/2022, the MHRA has not received any adverse drug reaction reports of Fournier’s gangrene in association with alogliptin via the Yellow Card scheme. When reviewing the data within an iDAP it is important to do so in the context of the essential guidance at the bottom of the report to ensure that you do not misinterpret the data.
There is another group of medicines used to treat type 2 diabetes called SGLT2 inhibitors, in the UK these are medicines that contain dapagliflozin, canagliflozin, empagliflozin, and ertugliflozin. Cases of Fournier’s gangrene have been reported in patients taking SGLT2 inhibitors. Although diabetes mellitus is a risk factor for the development of Fournier’s gangrene, some reports were considered possibly to be related to the use of SGLT2 inhibitors. As such, SGLT2 inhibitors list Fournier’s gangrene as a possible side effect in their product information. The MHRA released a Drug Safety Update (DSU) article regarding SGLT2 inhibitors and reports of Fournier’s gangrene in February 2019, which is available here.
The MHRA is not able to comment on why Fournier’s gangrene is listed on the NHS page Side effects of alogliptin as the MHRA does not have editorial control over the content of the NHS website. We suggest that you direct your enquiry to the NHS website team. You can find out how to contact the NHS here.
I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team
Patient Safety Monitoring