The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2021 (PDF).
This month readers are advised of a review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs conducted by the Commission on Human Medicines. It has confirmed that lamotrigine and levetiracetam are the safer of the medicines reviewed during pregnancy. It is recommended that clinicians use this information when discussing treatment options with women with epilepsy at routine recommended annual reviews and with women who are planning to become pregnant.
Readers are also signposted to the information available about the COVID-19 vaccines authorised for use in the UK, including advice for people with allergies and for women during pregnancy and breastfeeding.
This issue also highlights data from observational studies suggesting that the use of SSRI/SNRI antidepressants during the month before delivery may result in a small increased risk of postpartum haemorrhage. Prescribers should consider this risk in the context of an individual patient's bleeding and thrombotic risk assessment during the peripartum period and the benefits of antidepressants for the patient's mental health during this time.
Finally this month, aminoglycosides have been linked with an increased risk of deafness in patients with mitochondrial mutations with some reports of this happening at serum levels within the recommended ranges. Micochondrial mutations are rare but genetic testing may need to be considered especially in patients requiring recurrent or long-term treatment with aminoglycosides. Urgent treatment should not be delayed while awaiting genetic testing results.
The summary of letters to healthcare professionals were generally regarding product recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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