FOI release

Freedom of Information request on the reports of lipodystrophies from medroxyprogesterone (FOI 22/417)

Published 31 May 2022

FOI 22/417

23rd February 2022

Dear

Thank you for your email dated 3rd February 2022, where you requested detailed reports of all lipodystrophies reported with medroxyprogesterone.

Yellow Card data is releasable to members of the public provided that patient and reporter confidentiality is maintained. Under the Freedom of Information Act (FOIA) 2000, the data for this request has been provided as category Ib. For this FOI, the line listings contain the following fields:

• Patient age categories (as aggregated data)

• Patient sex categories (as aggregated data)

• Suspect drug(s)

• Dose of suspect drug(s)

• Route of administration of suspect drug(s)

• Suspected adverse drug reaction(s)

• Adverse drug reaction outcome(s)

• Time to onset

• Past medical history

Firstly, it may be helpful to provide some information on how we code adverse drug reaction (ADR) reports within our database. MedDRA (Medical Dictionary for Regulatory Activities) is a clinically validated international medical terminology dictionary. It’s organised by System Organ Class (SOC), divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT) and finally into Lowest Level Terms (LLT). MedDRA is a rich and highly specific standardised medical terminology developed to facilitate the sharing of regulatory information internationally for medical products used by humans; further information regarding MedDRA can be found here.

In response to your request I can confirm that up to and including 16th February 2022, the MHRA has received a total of 27 UK spontaneous suspected ADR reports specifying an ADR in the lipodystrophies HLT of the MedDRA hierarchy in association with medroxyprogesterone use. The requested information is presented in Table 1a and aggregated patient age and sex data are presented in Tables 1b and 1c; please see this summary attached in response to your email.

When considering the spontaneous ADR data, it is important to be aware of the following points:

• The fact that symptoms or events occur after use of a medicine or vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the medicine or vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card Scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, and the extent of use of a particular drug. Reporting may also be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

If you are not already aware, the MHRA publishes some information on suspected side-effects in the form of interactive Drug Analysis Profiles (iDAPs) which can be accessed on our website. iDAPs enable you to interact with the data so you can understand more about the types of reactions that have been reported, and at a high level about who experienced the side effects. The iDAP for medroxyprogesterone can be found here and information on lipodystrophies can be found under the skin and subcutaneous tissue disorders system organ class (SOC).

Any emerging evidence relating to possible risks associated with medroxyprogesterone is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed. As the data provided do not necessarily refer to proven side-effects of medroxyprogesterone, you should refer to the product information for further details, which can be found here: https://products.mhra.gov.uk/. To note, acquired lipodystrophy is a listed side effect for both Sayana Press and Depo-Provera.

The MHRA continuously monitors the safety of medicines and vaccines through a variety of pharmacovigilance processes including the Yellow Card Scheme. As part of our signal detection activities, all ADR reports received by the Yellow Card Scheme are individually assessed and the cumulative information is reviewed at regular intervals.

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,

Vigilance and Risk Management of Medicines Division