Tolvaptan: over-rapid increase in serum sodium and risk of serious neurological events

23rd April 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has warned that treatment with tolvaptan (Samsca, Otsuka) can result in over-rapid correction of hyponatraemia, which can lead to serious neurological events. They give specific advice for healthcare professionals on monitoring of serum sodium and the acceptable rate of rise of serum sodium during treatment and highlight that co-administration of other drugs or fluids with a high sodium content (e.g. normal or hypertonic saline) is not recommended. They also warn that tolvaptan may reduce the effect of vasopressin analogues (e.g. desmopressin) used to control or prevent bleeding.

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