Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy

Modafinil potentially increases the risk of congenital malformations when used in pregnancy.

Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing

Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome.

Ferric carboxymaltose (Ferinject▼): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures

Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia.

Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs

Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect.

Isotretinoin (Roaccutane▼): contribute to expert review

A review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group due to concerns about the possible associat…

Letters and drug alerts sent to healthcare professionals in October 2020

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

Posted on the UK MHRA website on 16 November 2020