Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has received an approvable letter from the US Food and Drug Administration (FDA) regarding two supplemental New Drug Applications (sNDA) for Risperdal (risperidone), filed on Dec 21, 2006.

The sNDAs are for the treatment of schizophrenia in adolescents ages 13-17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents ages 10-17 years, respectively. The FDA has not asked for any additional studies. J&JPRD is currently reviewing the approvable letter and looks forward to finalizing the label with the agency.

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Risperdal (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.

Schizophrenia the most common side effects that occurred with Risperdal were anxiety, sleepiness, restlessness, tremors and muscle stiffness; dizziness, constipation, nausea, indigestion, runny nose, rash and rapid heartbeat.

A rare but serious side effect that has been reported with this kind of medicine, including Risperdal, is known as neuroleptic malignant syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be serious.

Some people taking Risperdal may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your health care professional's dosing instructions, this side effect may be reduced or it may go away over time.