Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury

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. Although the temporary sus…

Pregabalin (Lyrica): reports of severe respiratory depression

Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …

Alkindi (hydrocortisone granules): risk of acute adrenal insufficiency in children when switching from hydrocortisone tablet formulations to granules

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 vigilant for symptoms of …

Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancy

Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.

COVID-19 vaccines and medicines: updates for February 2021

A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 16 February 2021.

Letters and drug alerts sent to healthcare professionals in January 2021

A summary of letters and drug alerts recently sent to healthcare professionals.

Posted on the UK MHRA website on 18 February 2021