Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

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 (Lamictal) and levetiracetam…

COVID-19 vaccines (Pfizer/BioNTech and COVID-19 Vaccine AstraZeneca): current advice

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.

Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia

The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy (PML) in patients with mild …

Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis

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 simplex and varicella zoster …

SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery

SSRIs and SNRIs are known to increase bleeding risks due to their effect on platelet function. Data from observational studies suggest that the use of SSRI/SNRI antidepressants during the month before delivery may resul…

Aminoglycosides (gentamicin, amikacin, tobramycin, and neomycin): increased risk of deafness in patients with mitochondrial mutations

Evidence suggests an increased risk of aminoglycoside-associated ototoxicity in patients with mitochondrial mutations, including cases in which the patient’s aminoglycoside serum levels were within the recommended range.

Letters and drug alerts sent to healthcare professionals in December 2020

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

Posted on the UK MHRA website on 7 January 2021