In the long-term study in subjects with schizoaffective disorder, the EPS during the 25-week open-label INVEGA SUSTENNA® treatment were hyperkinesia (%), parkinsonism (%), tremor (%), dyskinesia (%), and dystonia (%). During the 15-month double-blind treatment, the incidence of any EPS was similar to that of the placebo group (% and % respectively). The most commonly reported treatment-emergent EPS-related adverse events ( > 2%) in any treatment group in the double-blind phase of the study (INVEGA SUSTENNA® versus placebo) were hyperkinesia (% vs. %), parkinsonism (% vs. %), and tremor (% vs. %).
WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between to times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about %, compared to a rate of about % in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (., heart failure, sudden death) or infectious (., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL CONSTA ® is not approved for the treatment of patients with dementia-related psychosis.
Oral and injectable systemic corticosterois are steroid hormones prescribed to decrease inflammation in diseases and conditions such as arthritis (rheumatoid arthritis, for example), ulcerative colitis, Crohn's disease, asthma, bronchitis, some skin rashes, and allergic or inflammatory conditions that involve the nose and eyes. Examples of systemic corticosteroids include hydrocortisone (Cortef), cortisone, prednisone (Prednisone Intensol), prednisolone (Orapred, Prelone), and methylprednisolone (Medrol, Depo-Medrol, Solu-Medrol). Some of the side effects of systemic corticosteroids are swelling of the legs, hypertension, headache, easy bruising, facial hair growth, diabetes, cataracts, and puffiness of the face.