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GEODON: ADVERSE REACTIONS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical trials for oral ziprasidone included approximately 5700 patients and/or normal subjects exposed to one or more doses of ziprasidone. Of these 5700, over 4800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1831 patient-years. These patients include:

  • 4331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1698 patient-years of exposure as of February 5, 2000;
  • 472 patients who participated in bipolar mania trials representing approximately 133 patient-years of exposure. An additional 127 patients with bipolar disorder participated in a long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone.

    The conditions and duration of treatment with ziprasidone included open-label and double-blind studies, inpatient and outpatient studies, and short-term and longer-term exposure. Clinical trials for intramuscular ziprasidone included 570 patients and/or normal subjects who received one or more injections of ziprasidone. Over 325 of these subjects participated in trials involving the administration of multiple doses.

    Adverse reactions during exposure were obtained by collecting voluntarily reported adverse experiences, as well as results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.

    The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

    Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Geodon (Ziprasidone Hydrochloride)

    The following findings are based on the short-term placebo-controlled premarketing trials for schizophrenia (a pool of two 6-week, and two 4-week fixed-dose trials) and bipolar mania (a pool of two 3-week flexible-dose trials) in which ziprasidone was administered in doses ranging from 10 to 200 mg/day.

    Commonly Observed Adverse Reactions in Short Term-Placebo-Controlled Trials

    The following adverse reactions were the most commonly observed adverse reactions associated with the use of ziprasidone (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (ziprasidone incidence at least twice that for placebo):

    Schizophrenia trials

  • Somnolence
  • Respiratory Tract Infection

    Bipolar trials

  • Somnolence
  • Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials.
  • Akathisia
  • Dizziness which includes the adverse reaction terms dizziness and lightheadedness.
  • Abnormal Vision
  • Vomiting
  • Asthenia

    Schizophrenia

    Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials of Oral Geodon (Ziprasidone HCl)

    Approximately 4.1% (29/702) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 2.2% (6/273) on placebo. The most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients.

    Dose Dependency of Adverse Reactions in Short-Term, Fixed-Dose, Placebo-Controlled Trials

    An analysis for dose response in the schizophrenia 4-study pool revealed an apparent relation of adverse reaction to dose for the following reactions: asthenia, anorexia, postural hypotension, dry mouth, arthralgia, increased salivation, anxiety, dystonia, dizziness, hypertonia, tremor, somnolence, rhinitis, rash, and abnormal vision.

    Extrapyramidal Symptoms (EPS)

    The incidence of reported EPS (which included the adverse reaction terms extrapyramidal syndrome, dystonia, hypertonia, dyskinesia, tremor, hypokinesia, paralysis and twitching) for ziprasidone-treated patients in the short-term, placebo-controlled schizophrenia trials was 14% vs. 8% for placebo. Objectively collected data from those trials on the Simpson-Angus Rating Scale (for EPS) and the Barnes Akathisia Scale (for akathisia) did not generally show a difference between ziprasidone and placebo.

    Dystonia

    Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

    Vital Sign Changes

    Ziprasidone (Geodon) is associated with orthostatic hypotension.

    Weight Gain

    The proportions of patients meeting a weight gain criterion of >= 7% of body weight were compared in a pool of four 4- and 6-week placebo-controlled schizophrenia clinical trials, revealing a statistically significantly greater incidence of weight gain for ziprasidone (10%) compared to placebo (4%). A median weight gain of 0.5 kg was observed in ziprasidone patients compared to no median weight change in placebo patients. In this set of clinical trials, weight gain was reported as an adverse reaction in 0.4% and 0.4% of ziprasidone and placebo patients, respectively. During long-term therapy with ziprasidone, a categorization of patients at baseline on the basis of body mass index (BMI) revealed the greatest mean weight gain and highest incidence of clinically significant weight gain (> 7% of body weight) in patients with low BMI (< 23) compared to normal (23-27) or overweight patients (> 27). There was a mean weight gain of 1.4 kg for those patients with a "low" baseline BMI, no mean change for patients with a "normal" BMI, and a 1.3 kg mean weight loss for patients who entered the program with a "high" BMI.

    ECG Changes

    Geodon (Ziprasidone) is associated with an increase in the QTc interval. In the schizophrenia trials, ziprasidone was associated with a mean increase in heart rate of 1.4 beats per minute compared to a 0.2 beats per minute decrease among placebo patients.

    Other Adverse Reactions Observed During the Premarketing Evaluation of Oral Ziprasidone Hydrochloride (Geodon)

    Following is a list of Costart terms that reflect treatment-emergent adverse reactions as defined in the introduction to the "adverse reactions" section reported by patients treated with ziprasidone in schizophrenia trials at multiple doses > 4 mg / day within the database of 3834 patients. All reported reactions are included except those already listed in labeling, those reaction terms that were so general as to be uninformative, reactions reported only once and that did not have a substantial probability of being acutely life-threatening, reactions that are part of the illness being treated or are otherwise common as background reactions, and reactions considered unlikely to be drug-related. It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it.

    Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions:

    Frequent: adverse reactions occurring in at least 1/100 patients (>= 1.0% of patients) (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing);

    Infrequent: adverse reactions occurring in 1/100 to 1/1000 patients (in 0.1-1.0% of patients)

    Rare: adverse reactions occurring in fewer than 1/1000 patients ( < 0.1% of patients).

    Body as a Whole

    Frequent: abdominal pain, fever, flu syndrome, accidental fall, chills, face edema, photosensitivity reaction, hypothermia, flank pain, motor vehicle accident.

    Cardiovascular System

    Frequent: tachycardia, postural hypotension, hypertension

    Infrequent: bradycardia, atrial fibrillation, angina pectoris

    Rare: first degree AV block, phlebitis, bundle branch block, pulmonary embolus, cerebral infarct, cardiomegaly, cerebrovascular accident, myocarditis, deep thrombophlebitis, thrombophlebitis

    Digestive System

    Frequent: vomiting, anorexia

    Infrequent: rectal hemorrhage, tongue edema, dysphagia

    Rare: jaundice, gum hemorrhage, fecal impaction, hematemesis, gamma glutamyl transpeptidase increased, cholestatic jaundice, hepatomegaly, hepatitis, leukoplakia of mouth, melena, fatty liver deposit

    Endocrine

    Rare: hyperthyroidism, hypothyroidism, thyroiditis

    Hemic and Lymphatic System

    Infrequent: ecchymosis, anemia, leukocytosis, eosinophilia, leukopenia, lymphadenopathy

    Rare: hypochromic anemia, thrombocytopenia, lymphocytosis, basophilia, monocytosis, lymphedema, thrombocythemia, polycythemia

    Metabolic and Nutritional Disorders

    Infrequent: transaminase increased, thirst, peripheral edema, creatine phosphokinase increased, hyperglycemia, alkaline phosphatase increased, dehydration, hypercholesteremia, lactic dehydrogenase increased, hypokalemia, albuminuria

    Rare: BUN increased, hyperlipemia, creatinine increased, hypocholesteremia, hypochloremia, hyperkalemia, hypoglycemia, hypoproteinemia, hyponatremia, glucose tolerance decreased, hyperchloremia, gout, hyperuricemia, hypoglycemicreaction, hypocalcemia, hypomagnesemia, respiratory alkalosis, ketosis

    Musculoskeletal System

    Frequent: myalgia

    Infrequent: tenosynovitis

    Rare: myopathy

    Nervous System

    Frequent: extrapyramidal syndrome, agitation, tremor, hypertonia, dystonia, dyskinesia, twitching, hostility, paresthesia, vertigo, confusion, hypokinesia, abnormal gait, hyperkinesia, oculogyric crisis, ataxia, hypesthesia, amnesia, delirium, cogwheel rigidity, hypotonia, dysarthria, akinesia, withdrawal syndrome, choreoathetosis, buccoglossal syndrome, diplopia, incoordination, neuropathy

    Infrequent: paralysis

    Rare: nystagmus, myoclonus, torticollis, opisthotonos, circumoral paresthesia, reflexes increased, trismus

    Respiratory System

    Frequent: dyspnea

    Infrequent: pneumonia, epistaxis

    Rare: hemoptysis, laryngismus

    Skin and Appendages

    Infrequent: urticaria, maculopapular rash, alopecia, exfoliative dermatitis, eczema, contact dermatitis, vesiculobullous rash

    Special Senses

    Frequent: fungal dermatitis

    Infrequent: dry eyes, conjunctivitis, tinnitus, cataract, blepharitis, photophobia

    Rare: visual field defect, eye hemorrhage, keratitis, keratoconjunctivitis

    Urogenital System

    Infrequent: abnormal ejaculation, impotence, amenorrhea, menorrhagia, hematuria, female lactation, urinary retention metrorrhagia, polyuria, male sexual dysfunction, glycosuria, anorgasmia

    Rare: vaginal hemorrhage, gynecomastia, nocturia, female sexual dysfunction, oliguria, uterine hemorrhage

    Bipolar Disorder

    Acute Treatment of Manic or Mixed Episodes

    Adverse Reactions Associated with Discontinuation of Treatment in Short Term, Placebo-Controlled Trials

    Approximately 6.5% (18/279) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 3.7% (5/136) on placebo. The most common reactions associated with dropout in the ziprasidone-treated patients were akathisia, anxiety, depression, dizziness, dystonia, rash and vomiting, with 2 dropouts for each of these reactions among ziprasidone patients (1%) compared to one placebo patient each for dystonia and rash (1%) and no placebo patients for the remaining adverse reactions.

    Weight Gain

    During a 6-month placebo-controlled bipolar maintenance study in adults with ziprasidone as an adjunct to lithium or valproate, the incidence of clinically significant weight gain (>= 7% of body weight) during the double-blind period was 5.6% for both ziprasidone and placebo treatment groups who completed the 6 months of observation for relapse. Interpretation of these findings should take into consideration that only patients who adequately tolerated ziprasidone entered the maintenance phase of this study, and there were substantial dropouts by the 6 month endpoint.

    Intramuscular Ziprasidone Mesylate (Geodon)

    Adverse Reactions Occurring at an Incidence of 1% or More Among Ziprasidone-Treated Patients in Short-Term Trials of Intramuscular Ziprasidone

    In these studies, the most commonly observed adverse reactions associated with the use of intramuscular ziprasidone (incidence of 5% or greater) and observed at a rate on intramuscular ziprasidone (in the higher dose groups) at least twice that of the lowest intramuscular ziprasidone group were headache (13%), nausea (12%), and somnolence (20%).

    Postmarketing Experience

    The following adverse reactions have been identified during post approval use of Geodon. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Adverse reaction reports not listed above that have been received since market introduction include rare occurrences of the following:

    Cardiac Disorders: tachycardia, torsade de pointes (in the presence of multiple confounding factors)

    Digestive System Disorders: swollen tongue

    Reproductive System and Breast Disorders: galactorrhea, priapism

    Nervous System Disorders: facial droop, neuroleptic malignant syndrome, serotonin syndrome (alone or in combination with serotonergic medicinal products), tardive dyskinesia

    Psychiatric Disorders: insomnia, mania / hypomania

    Skin and subcutaneous Tissue Disorders: allergic reaction (such as angioedema, allergic dermatitis, orofacial edema, urticaria), rash

    Urogenital System Disorders: enuresis, urinary incontinence

    Vascular Disorders: postural hypotension, syncope.



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