"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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Clinical findings associated with MEXITIL (mexiletine hydrochloride, USP) overdosage have included drowsiness, confusion, nausea, hypotension, sinus bradycardia, paresthesia, seizures, bundle branch block, AV heart block, asystole, ventricular tachyarrhythmia, including ventricular fibrillation, cardiovascular collapse and coma. The lowest known dose in a fatality case was 4.4g with postmortem serum mexiletine level of 34-37 mcg/ml (Jequier P. et al. Lancet 1976: 1 (7956): 429). Patients have recovered from ingestion of 4g to 18g of mexiletine (Frank S. E. et al. Am J Emerg Med 1991: 9:43-48).
There is no specific antidote for MEXITIL (mexiletine hcl) . Management of MEXITIL (mexiletine hcl) overdosage includes general supportive measures, close observation and monitoring of vital signs. In addition, the use of pharmacologic interventions (e.g., pressor agents, atropine or anticonvulsants) or transvenous cardiac pacing is suggested, depending on the patient's clinical condition.
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