- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Drug Safety Update - November 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2020 (PDF).

This month readers are advised that modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil.

Additionally, pirfenidone (Esbriet®) has been linked with an increased risk of serious liver injury. Updated advice on liver function testing has been issued that recommends monthly checks during the first 6 months of treatment and every 3 months thereafter.

Ferric carboxymaltose (Ferinject®) has been linked with an increased risk of symptomatic hypophosphataemia leading to osteomalacia and fractures. Additional monitoring of phosphate levels is recommended for patients requiring multiple administrations at higher doses, on long-term treatment or with pre-existing risk factors for hypophosphataemia.

Finally in drug safety news, bupropion (Zyban®) has been associated with several cases of serotonin syndrome, especially when used with other serotonergic drugs or in cases of overdose. It is recommended that patients are informed about the milder symptoms of serotonin syndrome at initiation of treatment. If serotonin syndrome is suspected the dose of bupropion should be decreased or treatment withdrawn depending on the severity of the symptoms.

The summary of letters to healthcare professionals were generally regarding product recalls or supply disruptions.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.