Dear UCON Study Participant



>> Local Research Team Details <<>> Participant Details <<IMPORTANT: New safety information relating to Ulipristal Acetate (UPA)Dear >> Trial Participant <<We are writing to you as you are currently participating in our UCON trial and taking Ulipristal Acetate (UPA; Esmya). Our UCON research team may have already been in contact with you by telephone. The European Medicines Agency (EMA) and MHRA in UK are organisations which oversee all aspects of drug safety. They have issued the information below for patients currently taking Ulipristal Acetate.? Esmya (ulipristal acetate; UPA), used to treat uterine fibroids, is being reviewed because cases of serious liver problems have occurred in a few women worldwide taking the medicine. ? As a precaution, while taking Esmya you will be required to have blood tests to check that your liver is working well. If the tests indicate that you have a liver problem, your treatment will be stopped. ? If you have nausea (feeling sick), vomiting, upper belly pain, lack of appetite, tiredness or yellowing of the eyes or skin, contact your doctor immediately as these could be signs of liver problems. ? If you were about to start treatment with Esmya or start a new course of treatment, your doctor will discuss alternative treatment options until EMA’s review of the medicine is complete.? If your treatment has recently stopped, your doctor will perform a blood test to check how well your liver is working 2 to 4 weeks after you stop taking Esmya. The above measures are a precaution. To date no concerns, based upon symptoms reported by UCON participants, have been raised in the UCON trial.As a consequence of this guidance we would like to arrange for you to attend a research visit as soon as possible. During this visit you will be asked to provide a blood sample, to check your liver function and to discuss your onward clinical care. Based on the advice of the MHRA we are taking the following actions:If you currently taking UPA we will check liver function (blood test) at monthly intervals if you choose to complete your 12 week course of UPA.Trial participants currently on a 4 week no treatment interval will unfortunately not be able to resume further UPA treatment courses.If you have taken a UPA dose in the last 30 days, we will check your liver function (blood test). All participants will need to have a liver function test (blood test) 2-4 weeks after the last UPA tablet has been taken.As part of the UCON trial:We will arrange to see you for a womb lining check (endometrial biopsy) after the period following your last tablet. This was always planned as part of the study and is not an extra test.We will arrange to see you for an ultrasound scan, as previously planned as part of the study. This is not an extra test.Please continue to complete the follow up questionnaire and menstrual blood loss diary that are sent to you. Knowing the impact of this new advice upon your clinical symptoms and well-being is extremely important. We realise how incredibly disappointing this news will be to you after the commitment you have offered to our UCON study.Our study team will keep in touch with you and do our very best to minimise the impact of these extra visits and to ensure your clinical care is prioritised.Please feel free to contact us directly for further information using the contact details at the beginning of this letter. The research team are available to discuss this information with you and answer any questions or concerns you may have. Kind Regards, >> PI Signature <<>> PI Printed Name << ................
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