Propulsid Side Effects

Please note - some side effects for Propulsid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Propulsid Side Effects - for the Professional

Propulsid

In the U.S. clinical trial population of 1728 patients (comprising 506 with gastroesophageal reflux disorders, and the remainder with other disorders) the following adverse experiences were reported in more than 1% of patients treated with Propulsid® (cisapride) and at least as often on Propulsid® as on placebo.

The following adverse events also reported in more than 1% of Propulsid® patients were more frequently reported on placebo: dizziness, vomiting, pharyngitis, chest pain, fatigue, back pain, depression, dehydration and myalgia.

Diarrhea, abdominal pain, constipation, flatulence and rhinitis all occurred more frequently in patients using 20 mg of Propulsid® than in patients using 10 mg.

Additional adverse experiences reported to occur in 1% or less of patients in the U.S. clinical studies are: dry mouth, somnolence, palpitation, migraine, tremor and edema.

In other U.S. and international trials and in postmarketing experience, there have been rare reports of seizures and extrapyramidal effects. Also reported have been tachycardia, elevated liver enzymes, hepatitis, thrombocytopenia, leukopenia, aplastic anemia, pancytopenia and granulocytopenia. The relationship of Propulsid® to the event was not clear in these cases.

Cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation, in some cases resulting in death, have been reported.

Ongoing Postmarketing Surveillance: Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking Propulsid®. From July 1993 through May 1999, more than 270 such cases have been spontaneously reported, including 70 fatalities. In approximately 85% of these cases the events occurred when Propulsid®was used in patients with known risk factors. These risk factors included the administration of other drugs which caused QT prolongation, inhibited the cytochrome P450 3A4 enzymes that metabolize cisapride, or depleted serum electrolytes; or the presence of disorders that may have predisposed patients to arrhythmias. In approximately 0.7% of these cases, the events occurred in the absence of identified risk factors; in the remaining cases, risk factor status was unknown. Because the cases were reported voluntarily from a population of unknown size, estimates of adverse event frequency cannot be made. Propulsid®-induced serious ventricular arrhythmias and death may not correlate with the degree of drug-induced prolongation of the QT interval detected by 12-lead ECG.

In addition to the cardiovascular adverse events, the following events have been identified during post-approval use of Propulsid® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion in this insert due to a combination of their seriousness, frequency of reporting, or potential causal connection to Propulsid®: allergic reactions, including bronchospasm, urticaria, and angioedema; possible exacerbation of asthma; psychiatric events, including confusion, depression, suicide attempt, and hallucinations; extrapyramidal effects including akathisia, Parkinson-like symptoms, dyskinetic and dystonic reactions; gynecomastia, female breast enlargement, urinary incontinence, hyperprolactinemia and galactorrhea.

The following events were specifically reported in the pediatric population: antinuclear antibody (ANA) positive, anemia, hemolytic anemia, methemoglobinemia, hyperglycemia, hypoglycemia with acidosis, unexplained apneic episodes, confusion, impaired concentration, depression, apathy, visual changes accompanied by amnesia, and severe photosensitivity reaction.

There have been rare cases of sinus tachycardia reported. Rechallenge precipitated the tachycardia again in some of those patients.

Side Effects by Body System

General

Generally cisapride is well tolerated. Many of the side effects reported in clinical trials occurred with similar frequency in the placebo groups.

Gastrointestinal

Gastrointestinal side effects are often due the pharmacologic actions of cisapride. These effects appear to be dose-related, as 20 mg doses are associated with an increased incidence of diarrhea, abdominal pain, and flatulence compared to 10 mg doses.

In a study of 1500 patients, approximately 2.5% discontinued cisapride therapy, usually due to abdominal pain and intolerable diarrhea.

Gastrointestinal side effects have been reported the most frequently. These have included diarrhea or loose stools (14.2%), abdominal cramping (10.2%), nausea (7.6%), flatulence (3.5%), borborygmi (rumbling bowel sounds), and dry mouth.

Nervous system

Nervous system side effects have included headache (19.3%), dizziness, somnolence, and fatigue. In addition, seizures and extrapyramidal symptoms have been reported rarely.

While cisapride lacks antidopaminergic properties, extrapyramidal effects have been reported to the manufacturer. However, the incidence of cisapride-induced movement disorders would be expected to be significantly less than with metoclopramide, an antidopaminergic, gastrokinetic agent.

In addition, somnolence and fatigue are reported with lesser frequency during cisapride therapy (1.6%) than with metoclopramide (15.2%).

Worsening of tremor has been reported in two patients with parkinsonism who were treated with cisapride.

Hematologic

Hematologic side effects have rarely included thrombocytopenia, leukopenia, aplastic anemia, pancytopenia, and granulocytopenia.

Cardiovascular

Syncope associated with QT interval prolongation and nonsustained ventricular tachycardia occurred in a 64-year-old male taking cisapride 40 mg by mouth four times a day for diabetic gastroparesis. A baseline electrocardiogram was normal 6 days earlier. Gradual reduction in dosage to 5 mg four times a day resolved the prolonged QT interval. High dosages of cisapride may lead to a risk of ventricular arrhythmia and torsades de pointes.

Cardiovascular effects have reported rarely. These have included palpitations, tachycardia, and edema. Rare but potentially serious cardiac arrhythmias, including ventricular arrhythmias and torsades de pointes have also been reported.

Hepatic

Hepatic side effects have included elevations in liver function test results, and hepatitis.

Psychiatric

Psychiatric side effects have rarely included insomnia, anxiety, nervousness, and depression.

Genitourinary

Urinary symptoms usually begin within 48 hours of starting treatment with cisapride. Urinary frequency and incontinence generally resolve completely upon withdrawal of therapy and may recur during rechallenge with the drug.

Genitourinary side effects have included urinary frequency, urinary incontinence, and vaginitis.

Ocular

Ocular side effects have included visual changes (1.4%).

Respiratory

Respiratory side effects have included bronchospasm and wheezing in asthma patients. Rechallenge with cisapride led to reoccurrence of bronchospasm in one patient.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions, including bronchospasm, urticaria, and angioedema.

Endocrine

Endocrine side effects have been rarely reported. These have included gynecomastia in males, female breast enlargement, hyperprolactinemia, and galactorrhea.

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