In diabetes, selective sodium-glucose co-transporter 2 (SGLT-2) inhibitors dominated the news when the Medicines and Healthcare products Regulatory Agency (MHRA) issued a safety update for canagliflozin, stating that treatment increased the risk of lower limb amputations (mainly toes) and highlighting the importance of preventive footcare for all patients with diabetes. Although there is no evidence of an increased risk with dapagliflozin and empagliflozin, the MHRA pointed to limited data, stating that the risk could be a class effect.
Valproate: the risks of developmental disabilities and birth defects in babies born to mothers who take valproate medicines saw the MHRA issue a Patient Safety Alert. The MHRA asked all organisations to undertake systemic identification of women and girls on the antiepileptic, and the European Medicines Agency (EMA) kicked off a review into whether wider action is needed to minimise the risk.
Recombinant human erythropoetins (r-HuEPOs): the rare but potentially fatal risk of severe skin reactions – such as Steven-Johnsons syndrome (SJS) and toxic epidermal necrolysis – was highlighted, particularly with long-acting agents. Patients should be advised to contact their doctor immediately if they develop flu-like symptoms and a widespread rash with reddening and blistering of the skin and oral mucosa, eyes, nose, throat or genital area that may lead to peeling and shedding that resembles a burn.