Freedom of Information request (FOI 22/1014)
Published 17 January 2024
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12th October 2022
FOI 22/1014
Dear
We are sorry to hear of your unpleasant experiences. Acute pancreatitis is an identified side effect of gabapentin, although we cannot determine how often this occurs. The licence for gabapentin was authorised some time ago, and the event of acute pancreatitis was not revealed until after authorisation when more people were exposed to the medicine. Awareness of this possible side effect was reported in some individual countries in Europe and as a result, in 2004 a referral was initiated at the European Medicines Agency to harmonise the product information for healthcare professionals and patients to ensure that everyone had the same information about the possible side effect. A final decision was issued on 4 August 2006. Access to the public assessment report can be found at this website:
| [Neurontin | European Medicines Agency (europa.eu)](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2Freferrals%2Fneurontin&data=05%7C01%7CPharmacovigilanceservice%40mhra.gov.uk%7C72908045612747158b9408daac408ca8%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C638011690473394788%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Erq7a5fGg1nyDh5mbgIlvzlpZn8ypYdxEjwX9n9T47U%3D&reserved=0) |
The MHRA continues to receive adverse reaction reports through our Yellow-card Scheme, identifying new and old adverse reactions although, unfortunately, known adverse reactions are often not reported. These reports of adverse reactions will not necessarily tell you if the medicine caused the event merely that it is suspected as causing the reaction as there may also be other factors like the patient’s medical history and other medicines that have been taken. However, taking into consideration all available evidence including reports from the licence holders (manufacturers), literature, clinical trials and all other databases including the Yellow-card Scheme, it was agreed in 2006 that the side effect of acute pancreatitis should be included in the product information for gabapentin.
An electronic Drug Analysis Profile (iDAP) of all drugs consisting of all the side effects that people have reported to the MHRA when they have taken a medicine is available at:
Check drug analysis profiles (iDAPs) - GOV.UK (www.gov.uk)
The iDAP contains all side effects reported in our Yellow-card scheme since launch on the market, although may not be case for all medicines which were authorised before the development of the Yellow-card scheme. In the iDAP, you can select the drug which you want to see, and select the items that you want to see. The first report for gabapentin submitted to the Yellow-card scheme was in 1993. Acute Pancreatitis comes under the System Organ Class, Gastrointestinal disorders (total 901 reports), of which there are 22 reports of exocrine pancreas disorders; of which 19 are acute and chronic pancreatitis.
Please note that all Yellow-card reports are anonymised for patient confidentiality.
If you have a query about the information provided, please reply to this email 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 you receive this response and addressed to: info@mhra.gov.uk Please remember to quote the reference number above in any future communications. If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
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Yours sincerely
FOI Team,
Safety and Surveillance