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ORAP (PIMOZIDE): ADVERSE REACTIONS

General

Extrapyramidal Reactions

Neuromuscular (extrapyramidal) reactions during the administration of Pimozide (Orap) have been reported frequently, often during the first few days of treatment. In most patients, these reactions involved Parkinson-like symptoms which, when first observed, were usually mild to moderately severe and usually reversible.

Other types of neuromuscular reactions (dystonia, motor restlessness, akathisia, opisthotonos, hyperreflexia, oculogyric crises) have been reported far less frequently. Severe extrapyramidal reactions have been reported to occur at relatively low doses. Generally the occurrence and severity of most extrapyramidal symptoms are dose-related since they occur at relatively high doses and have been shown to disappear or become less severe when the dose is reduced. Administration of antiparkinson drugs such as benztropine mesylate or trihexyphenidyl hydrochloride may be required for control of such reactions. It should be noted that persistent extrapyramidal reactions have been reported and that the drug may have to be discontinued in such cases.

Withdrawal Emergent Neurological Signs

Generally, patients receiving short term therapy experience no problems with abrupt discontinuation of antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under "Tardive Dyskinesia" except for duration. It is not known whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent neurological signs, but until further evidence becomes available, it seems reasonable to gradually withdraw use of Pimozide (Orap) tablets.

Tardive Dyskinesia

Orap may be associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may appear in some patients on long-term therapy or may occur after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by rhythmical involuntary movements of tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities and the trunk.

There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, this syndrome may be masked.

It has been reported that fine vermicular movement of the tongue may be an early sign of tardive dyskinesia and if the medication is stopped at that time the syndrome may not develop.

Electrocardiographic Changes

Electrocardiographic changes have been observed in clinical trials of Orap (Pimozide) in Tourette's Disorder and schizophrenia. These have included prolongation of the QT interval, flattening, notching and inversion of the T wave and the appearance of U waves. Sudden, unexpected deaths and grand mal seizure have occurred at doses above 20 mg per day.

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS) has been reported with Orap (Pimozide) tablets.

Hyperpyrexia

Hyperpyrexia has been reported with other antipsychotic drugs.

Because clinical investigational experience with Pimozide (Orap) in Tourette's Disorder is limited, uncommon adverse reactions may not have been detected. The physician should consider that other adverse reactions associated with antipsychotics may occur.

Other Adverse Reactions

In addition to the adverse reactions listed above, those listed below have been reported in U.S. clinical trials of ORAP in conditions other than Tourette's Disorder.

Body as a Whole: Asthenia, chest pain, periorbital edema.

Cardiovascular / Respiratory: Postural hypotension, hypertension, hypotension, tachycardia, palpitations.

Gastrointestinal: Increased salivation, vomiting, nausea, anorexia, GI distress.

Endocrine: Loss of libido.

Metabolic / Nutritional: Weight gain, weight loss.

Central Nervous System: Dizziness, parkinsonism, tremor, fainting, dyskinesia.

Psychiatric: Excitement.

Skin: Rash, sweating, skin irritation.

Special Senses: Blurred vision, cataracts.

Urogenital: Nocturia, urinary frequency.

Postmarketing Reports

The following experiences were described in spontaneous postmarketing reports. These reports do not provide sufficient information to establish a clear causal relationship with the use of Pimozide (Orap) tablets.

Gastrointestinal: Gingival hyperplasia in one patient.

Hematologic: Hemolytic anemia.

Metabolic / Nutritional: Hyponatremia.

Other: Seizure.

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