MHRA Drug Safety Update
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 (Lamictal) and levetiracetam (Keppra) are the safer of the medicines reviewed during pregnancy. This review was initiated in the context of the known harms of valproate in pregnancy, which should only be prescribed to women of childbearing potential if there is a pregnancy prevention programme in place.
Clinicians should use this information when discussing treatment options with women with epilepsy at initiation and at routine recommended annual reviews and with women who are planning to become pregnant.
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.
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 lymphopenia.
Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury.
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 result in a small increased risk of postpartum haemorrhage.
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.
A summary of letters and drug alerts recently sent to healthcare professionals.
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