Janet and I (INFACT) have been working with MHRA (Medicines and Healthcare Regulatory Agency) since 16th August 2013. We had a meeting with them to discuss how they can monitor Epilim and other AEDs during pregnancy. We felt that MHRA were not covering aspects related to medication Epilim and other medications. One of the many points we raised at the meeting we had was the fact that when a person reports an effect of a medicine they couldnt report the effect on the Foetus/baby. The Yellow Card has now been updated so if any mums on AEDs or other medication feel their medicine is affecting the baby you can now report this more thoroughly.
All medicines can cause side effects. Some may not yet be known so that’s why it’s important for people to report to the Yellow Card Scheme. Many side effects are mild, but some can be serious and even life-threatening. Others appear after taking a medicine for a long time or even after stopping a medicine.
It is important for people to report as these are used to identify side effects and other problems which might not have been known about before. If a new side effect is found, the MHRA will review the way that the medicine can be used, and the warnings that are given to people taking it to minimise risk and maximise benefit to the patient.
If you would like to report an adverse incident involving a medical device, an adverse blood reaction/event or a suspected counterfeit product please click on the link below