Add this result to my export selection Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 18 February 2021 The indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Read Summary Type: Safety Alerts (Add filter)
Add this result to my export selection Pregabalin (Lyrica): reports of severe respiratory depression Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 18 February 2021 Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised... Read Summary Type: Safety Alerts (Add filter)
Add this result to my export selection Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancy Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 18 February 2021 Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy. Read Summary Type: Safety Alerts (Add filter)
Add this result to my export selection Alkindi (hydrocortisone granules): risk of acute adrenal insufficiency in children when switching from hydrocortisone tablet formulations to granules Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 18 February 2021 When children receiving replacement therapy for adrenal insufficiency are being switched from hydrocortisone tablets to Alkindi granules, parents or carers should be informed of the need to be extra... Read Summary Type: Safety Alerts (Add filter)
Add this result to my export selection Letters and drug alerts sent to healthcare professionals in January 2021 Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 18 February 2021 A summary of letters and drug alerts recently sent to healthcare professionals. Read Summary Type: Safety Alerts (Add filter)
Add this result to my export selection COVID-19 vaccines and medicines: updates for February 2021 Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 18 February 2021 A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 16 February 2021. Read Summary Type: Safety Alerts (Add filter)
Add this result to my export selection Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 07 January 2021 A review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs by the Commission on Human Medicines has confirmed that lamotrigine... Read Summary Type: Safety Alerts (Add filter)
Add this result to my export selection Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 07 January 2021 Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes... Read Summary Type: Safety Alerts (Add filter)
Add this result to my export selection Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 07 January 2021 The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy... Read Summary Type: Safety Alerts (Add filter)
Add this result to my export selection COVID-19 vaccines (Pfizer/BioNTech and COVID-19 Vaccine AstraZeneca): current advice Source: GOV UK (Remove filter) Source: Medicines and Healthcare products Regulatory Agency - MHRA (Add filter) Published by Medicines and Healthcare products Regulatory Agency, 07 January 2021 Recent advice from the MHRA on the COVID-19 vaccines authorised for use in the UK, including advice for people with allergies and for women during pregnancy and breastfeeding. Read Summary Type: Safety Alerts (Add filter)