Revised indication on the use of risperidone for treatment of dementia

HSA, in consultation with its Medicines Advisory Committee, would like to update healthcare professionals on the new restrictions on the use of risperidone-containing products, following concerns on the higher risk of cerebrovascular adverse events (CVAE) in patients with mixed/vascular dementia (MD/VD) versus Alzheimer’s dementia (AD).   HSA’s benefit-risk assessment, which considered the current available scientific evidence, the local situation and the input of local clinical experts,  concluded that the benefit-risk profile of risperidone remains favourable. However,  the licensed indication of risperidone will be revised to the short-term treatment of persistent aggression in patients with AD only. It will no longer be recommended for use in other types of dementia, such as MD/VD. Physicians are advised to assess the risks and benefits of the use of risperidone in elderly patients with dementia, taking into account risk predictors for stroke in the individual patient. Patients/caregivers should be cautioned to immediately report signs and symptoms of potential CVAEs, such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems. All treatment options should be considered without delay, including discontinuation of risperidone. Patients should be re-assessed regularly to determine the need for continued treatment. Please refer to the letter for details. Published: 16 Jun 2016

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