crisis

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Table 19: Incidence of EPS Compared to Placebo in the Adjunctive Therapy Bipolar Depression Studies LATUDA Placebo 20to 120 mg/day (N=334) (N=360) Adverse Event Term (%) (%) All EPS events 13 24 All EPS events, excluding 9 14 Akathisia/ Restlessness Akathisia 5 11 Dystonia * <1 1 Parkinsonism ** 8 13 Restlessness <1 4 Note: Figures rounded to the nearest integer * Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus ** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor
When the atypical antipsychotics are compared to typical ones, dystonic reactions and therefore cause of oculogyric crisis are not expected.
3 Confirmed rechallenge data were seen in 6 cases of oculogyric crisis while 8 cases underwent thorough neurologic consultation with radiographic proceedings.
Table 18: Incidence of EPS Compared to Placebo in the Monotherapy Bipolar Depression Study LATUDA Adverse Event Term Placebo 20 to 60 mg/day 80 to 120 mg/day (N=168) (N=164) (N=167) (%) (%) (%) All EPS events 5 12 20 All EPS events, 2 5 9 excluding Akathisia/ Restlessness Akathisia 2 8 11 Dystonia* 0 0 2 Parkinsonism** 2 5 8 Restlessness <1 0 3 Note: Figures rounded to the nearest integer *Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus **Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor
Other more recently introduced antipsychotic drugs, such as Clozapine, Risperidone, and Olanzepine have been mostly associated with the side effect of oculogyric crisis, (9,10) which is an ocular dystonia whereby the eyes deviate upwards; the crisis is associated with autonomic symptoms such as pupil dilation, salivation, catatonia, high blood pressure, as well as with depression, obsessions and even violence.
Table 18: Incidence of EPS Compared to Placebo in the Monotherapy Bipolar Depression Study LATUDA 20 to 60 80 to 120 Placebo mg/day mg/day (N=168) (N=164) (N=167) Adverse Event Term (%) (%) (%) All EPS events 5 12 20 All EPS events, excluding Akathisia/ 2 5 9 Restlessness Akathisia 2 8 11 Dystonia * 0 0 2 Parkinsonism ** 2 5 8 Restlessness <1 0 3 Note: Figures rounded to the nearest integer * Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus ** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor
When the atypical antipscyhotics are compared to typical ones, dystonic reactions and therefore cause of oculogyric crisis are not expected.