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ELDEPRYL (SELEGILINE HCL) TABLETS: ADVERSE REACTIONS / SIDE EFFECTS

Introduction

The number of patients who received selegiline in prospectively monitored pre-marketing studies is limited. While other sources of information about the use of selegiline are available (e.g., literature reports, foreign post-marketing reports, etc.) they do not provide the kind of information necessary to estimate the incidence of adverse events. Thus, overall incidence figures for adverse reactions associated with the use of selegiline cannot be provided. Many of the adverse reactions seen have also been reported as symptoms of dopamine excess.

Moreover, the importance and severity of various reactions reported often cannot be ascertained. One index of relative importance, however, is whether or not a reaction caused treatment discontinuation. In prospective pre-marketing studies, the following events led, in decreasing order of frequency, to discontinuation of treatment with selegiline: hallucinations, nausea, confusion, loss of balance, depression, insomnia, orthostatic hypotension, increased akinetic involuntary movements, arrhythmia, agitation, bradykinesia, delusions, chorea, hypertension, new or increased angina pectoris, and syncope. Events reported only once as a cause of discontinuation are anxiety, ankle edema, burning lips/mouth, drowsiness/lethargy, constipation, dystonia, increased freezing, excess perspiration, gastrointestinal bleeding, increased tremor, hair loss, nervousness, weakness, and weight loss.

Experience with Eldepryl obtained in parallel, placebo controlled, randomized studies provides only a limited basis for estimates of adverse reaction rates. The following reactions that occurred with greater frequency among the 49 patients assigned to selegiline as compared to the 50 patients assigned to placebo in the only parallel, placebo controlled trial performed in patients with Parkinson's disease are shown in the following Table. None of these adverse reactions led to a discontinuation of treatment.

Incidence of treatment-emergent adverse experiences in the placebo-controlled clinical trial

Adverse Event: Nausea, dizziness/light-headed/fainting abdominal pain, confusion, hallucinations, dry mouth, vivid dreams, dyskinesias, headache.

The following events were reported once in either or both groups: ache, anxiety/tension, anemia, diarrhea, hair loss, insomnia, lethargy, leg pain, low back pain, malaise, palpitations, urinary retention, weight loss.

In all prospectively monitored clinical investigations, enrolling approximately 920 patients, the following adverse events, classified by body system, were reported.

Central Nervous System

Motor/Coordination/Extrapyramidal: chorea, increased tremor, loss of balance, blepharospasm, restlessness, increased bradykinesia, falling down, facial grimace, heavy leg, myoclonic jerks, muscle twitch, stiff neck, dystonic symptoms, tardive dyskinesia, dyskinesia, freezing, involuntary movements, festination, muscle cramps, increased apraxia.

Mental Status/Behavioral/Psychiatric: dizziness, hallucinations, confusion, depression, anxiety, drowsiness, dreams/nightmares, behavior/mood change, tiredness, disorientation, delusions, lightheadedness, impaired memory, transient high, increased energy, hollow feeling, apathy, lethargy/malaise, overstimulation, personality change, vertigo, sleep disturbance, weakness, restlessness, transient irritability.

Pain/Altered Sensation: back pain, headache, leg pain, migraine, tinnitus, supraorbital pain, generalized ache, throat burning, chills, taste disturbance, numbness of toes/fingers.

Autonomic Nervous System: blurred vision, dry mouth, sexual dysfunction.

Cardiovascular: hypertension, orthostatic hypotension, arrhythmia, new or increased angina pectoris, palpitations, hypotension, peripheral edema, tachycardia, sinus bradycardia, syncope.

Gastrointestinal: constipation, nausea/vomiting, weight loss, poor appetite, anorexia, dysphagia, heartburn, diarrhea, rectal bleeding, bruxism, gastrointestinal bleeding (exacerbation of preexisting ulcer disease).

Genitourinary/Gynecologic/Endocrine: transient anorgasmia, slow urination, nocturia, urinary hesitancy, prostatic hypertrophy, urinary retention, urinary frequency, decreased penile sensation.

Skin and Appendages: diaphoresis, increased sweating, facial hair, hematoma, hair loss, rash, photosensitivity.

Miscellaneous: diplopia, asthma, shortness of breath, speech affected.

Post-marketing Reports

The following experiences were described in spontaneous post-marketing reports. These reports do not provide sufficient information to establish a clear causal relationship with the use of Selegiline (Eldepryl) tablets.

CNS: seizure in dialyzed chronic renal failure patient on concomitant medications.

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