The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2021 (PDF).
This month readers are advised of further restrictions on the use of ulipristal acetate (Esmya®) for uterine fibroids due to the risk of serious liver injury. The temporary suspension has been lifted but it is recommended that this medicine should only be used for intermittent treatment of moderate to severe symptoms before the menopause and when surgical procedures (including uterine fibroid embolisation) are not suitable or have failed.
Readers are also notified that pregabalin (Lyrica®) has been linked with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients considered at higher risk of this complication include those with respiratory disease, neurological disease, renal impairment, those using concomitant CNS depressants and people older than 65 years. In such patients a more cautious introduction to this medication may be prudent and adjustments in dose or dosing regimen may be necessary.
An increased risk of acute adrenal insufficiency in children has also been identified when switching from hydrocortisone tablet formulations to granules (Alkindi®). During such switches, parents or carers should be informed of the need to be extra vigilant for symptoms of adrenal insufficiency.
This issue also contains information about the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium. This is a partnership of 16 leading organisations working together to improve the health information available to women who are thinking about becoming pregnant, are pregnant, or are breastfeeding, especially relating to the medicines they take. To support this work healthcare professionals are being asked to report inconsistencies in UK advice on use of individual or classes of medicines used in pregnancy or breastfeeding via the address on the consortium's webpage.
Finally in this issue is a summary of advice recently issued by the MHRA relating to coronavirus (COVID-19) vaccines and medicines as well as the summary of letters to healthcare professionals sent in January.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
|« SMC Update - February 2021||NICE Guidance - February 2021 »|