The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2018 (PDF).
This issue advises that there is an increased risk of neural tube defects in women who become pregnant while taking dolutegravir for the treatment of HIV. If pregnancy is confirmed in the first trimester their specialist should consider switching to an alternative treatment.
This issue also notifies readers of two emerging concerns regarding denosumab (Xgeva® ▼). Rebound hypercalcaemia have been reported up to 9 months after discontinuation of denosumab. Periodic monitoring of serum calcium is recommended. A pooled analysis has also shown an increased incidence of new primary malignancies in patients treated with denosumab compared to zoledronic acid. All suspected adverse reactions for denosumab should be reported, including any new primary malignancies.
Finally this month, the summary of letters to healthcare professionals includes a reminder of false readings seen with certain batches of Accu-Chek test strips, as reported last month.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.