MHRA Drug Safety Update
January 2024
New safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males. These safety and educational materials support the new regulatory measures announced in the National Patient Safety Alert.
Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate. This follows a review by the MHRA which looked at the effectiveness of current measures to reduce the identified risk of disabling and potentially long-lasting or irreversible side effects.
Systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl ester medicines compared to placebo.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Drug Safety Update is a monthly newsletter from the Medicines and Healthcare products Regulatory Agency (MHRA) and its independent advisor the Commission on Human Medicines.
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