Noncardiac adverse effects and organ toxicity of moricizine during short- and long-term studies.
To determine the tolerance and safety of moricizine, the incidence and nature of its noncardiac adverse effects and organ toxicity reported during short- and long-term clinical studies were examined. From a pooled data base of 1,256 adult patients and healthy subjects, the most frequent non-cardiac adverse events were gastrointestinal (nausea) and neurologic (dizziness) complaints which occurred in 10 to 15% of patients during short-term (less than 3 months) studies and increased to 20 to 25% during long-term (greater than 12 months) studies. Adverse effects led to discontinuation of moricizine therapy in 116 patients (9%). Organ toxicity consisted predominantly of drug fever, possible thrombocytopenia and elevated liver function tests and was quite low (less than 0.7%) for both short- and long-term studies. Moricizine appears to be a well-tolerated antiarrhythmic drug with low occurrence of noncardiac adverse effects without significant serious organ toxicity.
Kennedy
H L
HL
Department of Internal Medicine, St. Louis University Medical Center, Missouri.
D000328:Adult; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D004244:Dizziness / Q000139:chemically induced; D004361:Drug Tolerance; D005334:Fever / Q000139:chemically induced; D006801:Humans; D008111:Liver Function Tests; D016293:Moricizine; D009325:Nausea / Q000139:chemically induced; D010640:Phenothiazines / Q000009:adverse effects* / Q000627:therapeutic use; D013921:Thrombocytopenia / Q000139:chemically induced; D013997:Time Factors
D000889:Anti-Arrhythmia Agents; D010640:Phenothiazines; D016293:Moricizine