Inadvertent oral administration of methylergometrine maleate to children in the first months of life: from surveillance to prevention.

PURPOSE: Methylergometrine maleate is an ergot alkaloid frequently used in obstetrics for prevention and treatment of post partum haemorrhage. Accidental administration of this medicine to newborns can cause severe effects and should be carefully prevented. The present paper is aimed at describing the main characteristics of cases accidentally exposed to this medicine in Italy before and after Novartis, the manufacturer of Methergin®, a widely used methylergometrine maleate-containing gynecological medication, decided to withdraw the drop preparation from the European market. METHODS: The study design is a case-series study. The database of the National Poison Control Centre of Milan was searched retrospectively (from 1 January 2005 to 31 December 2011) and prospectively (from 1 January 2012 to 31 December 2013) in order to provide a descriptive analysis of the main characteristics of cases unintentionally exposed to methylergometrine maleate and to document the impact of Novartis' decision. RESULTS: In the first period under study (2005-2011), a total of 642 cases of exposure to methylergometrine maleate were identified. Most of them were children aged <1 year (No. 483, 75%). Patients aged 1-2 and 3-5 years accounted for 13% (No. 85) and 9% (No. 56) of cases, respectively. Among children aged <1 year, about 76% (No. 368) were exposed during the first month of life, including 44% (No. 211) of cases exposed in the first week of life. The main cause of exposure was medication error (No. 432, 89%), mainly due to oral administration of methyltergometrine maleate in place of a paediatric preparation (No. 469, 97%). About 14% of these cases suffered clinical effects as a consequence of the exposure. Severity of poisoning was minor in 45 cases, moderate in 12, and severe in one case. The main cause of exposure among children aged 1-2 and 3-5 years was uncontrolled access to the medicine, accounting for 78% (No. 66) and 77% (No. 43) of cases, respectively. Some 9% (No. 8) of cases aged 1-2 years and 7% (No. 4) of those aged 3-5 years developed signs/symptoms possibly related to the exposure. For all of them, severity of clinical effects was low, but one case suffered moderate effects. Exposure to the medicine in drops was reported for 87% (No. 74) and 84% (No. 47) of cases aged 1-2 and 3-5 years, respectively. In 2012-2013 a total of 25 cases were observed. Among them, two patients were aged <1 year (8%). Both cases occurred in 2012 and were inadvertently administered the medicine in drops still available (present) in the home. Fourteen (56%) and 8 (32%) cases were aged 1-2 and 3-5 years, respectively. All of them were exposed to the tablet formulation following uncontrolled access to the medicine. CONCLUSIONS: The observations here reported indicate that having different formulations for methylergometrine maleate-containing products intended for the mother and paediatric medicines can successfully prevent medication error due to medicine exchange in the first months of life.

Management of methylergonovine induced respiratory depression in a newborn with naloxone.

INTRODUCTION: We report a case of a female neonate who developed respiratory depression following the unintentional administration of methylergonovine. The respiratory depression appeared to improve after the administration of bag mask ventilation, stimulation, and naloxone; and the baby was able to be managed without endotracheal intubation and prolonged positive-pressure ventilation. CASE: A full-term female neonate was delivered vaginally without issue. Approximately 10 min after delivery, the infant was inadvertently administered 0.1 mg of methylergonovine intramuscularly instead of vitamin K. Thirty minutes later the child developed cyanotic extremities and respiratory depression with an oxygen saturation of 75%. Naloxone, 0.4 mg IM, was recommended to mitigate respiratory depression. Within 5 min the patient's respirations improved to 40 breaths per minute, cyanosis improved, and she began resisting ventilations and crying loudly. The child continued to improve and was back to baseline that evening. DISCUSSION: Methylergonovine toxicity in neonates has been commonly associated with respiratory depression necessitating ventilatory support. In consideration of chemical structural similarity between methylergonovine and morphine, as well as signs/symptoms consistent with opioid-induced respiratory depression, naloxone was suggested. CONCLUSION: It appears that naloxone may reverse methylergonovine toxicity in neonates. The identification of a safe and potentially useful antidote to mitigate respiratory depression, potentially avoiding the need for intubation and more invasive interventions in this patient population is important.

Methylergometrine poisoning in the newborn: report of two cases.

Methylergometrine is probably the most commonly used drug in obstetric care at all levels of the health care system. Many communities in Africa lack skilled birth attendants and adequate health systems; medication errors are more likely to occur and go unreported in these settings. The morbidity and mortality that result from these errors can be reduced if health care workers are better informed. We report two cases of medication error with methylergometrine and suggest guidelines for health care workers at the primary and secondary levels of health care.

Neonatal ergot poisoning: a persistent iatrogenic illness.

Ergot toxicity in the newborn usually manifests itself as respiratory depression, cyanosis, oliguria, and seizures. Death is usually caused by respiratory failure. A limited number of neonatal cases have been reported worldwide, and almost all cases involved confusion of maternal methylergonovine with neonatal vitamin K. Previous case reports provided little information regarding the effectiveness and dosing of antidotal therapy, especially sodium nitroprusside. A full-term male infant was inadvertently given methylergonovine instead of naloxone at birth. Several hours later, he required intubation for respiratory failure. Peripheral perfusion, ventilation, and renal function improved rapidly with nitroprusside infusion, and he was extubated on the third hospital day. Even asymptomatic newborns should be transferred to a neonatal intensive care unit for close observation after methylergonovine administration because toxicity can be life threatening. Rapid recognition of the therapeutic error, ventilatory support, and prompt administration of sodium nitroprusside should lead to a good outcome.

Accidental child poisoning with methylergometrine intended for the mother.

(1) Erroneous administration to an infant of methylergometrine intended to treat postpartum haemorrhage in the mother can have severe repercussions for the child. (2) The risk is particularly high when the mother and newborn are being treated simultaneously immediately after delivery or in the postpartum period.

Carboprost exposure in a newborn with recovery.

BACKGROUND: This case describes a newborn who was accidentally given carboprost (Hemabate) 250 micrograms intramuscularly, the largest amount ever reported in a normal newborn. CASE REPORT: A full-term newborn was inadvertently given carboprost rather than his prescribed hepatitis vaccine. Within 15 minutes, he was tachypneic and hypertensive followed by bronchospasms and dystonic movements and/or seizure activity of his upper extremities. He also was hyperthermic and had diarrhea stools. He recovered within 18 hours and was discharged. CONCLUSION: The manufacturer reports 2 infants who received lesser amounts and remained asymptomatic. This child exhibited symptoms associated with an overdose of a prostaglandin F2a, although complete recovery occurred within 18 hours.

Overdose of ergometrine in the newborn infant: acute symptomatology and long-term outcome.

OBJECTIVE: To document the short- and long-term effects of accidental administration of ergometrine in adult dosage to the newborn infant. METHODS: The case records of all infants admitted to the Royal Children's Hospital (RCH) since 1970 with a diagnosis of acute ergometrine overdose were reviewed, and details of the acute symptomatology, management, and the neurodevelopmental outcome at follow-up were noted. Similar information was obtained, where available, from previous case reports, and from two major drug information services. Additionally, data relating to administration of uterotonic agents and vitamin K were collected from tertiary perinatal centres around Australia. RESULTS: Seven cases of neonatal ergometrine overdose were identified at RCH. The major features of the acute toxicity syndrome were: encephalopathy (100% RCH cases, 79% combined cases); seizures (100%, 70%); peripheral vascular disturbances (100%, 83%); and oliguria (43%, 34%). Other important symptoms were hypoxaemia, hypertension and feed intolerance. 86% of RCH cases (72% overall) required ventilatory support. Virtually all symptoms resolved within 4 days, and 86% of RCH infants (86% all cases) were neurologically intact at the time of discharge. Long-term neurodevelopmental outcome was normal in 100% of RCH infants (n=6). All the perinatal centres surveyed give vitamin K in the labour ward soon after delivery, and 7 of 18 (39%) reported using Syntometrine (ergometrine 0.5 mg, Syntocinon 5 IU) routinely during the third stage of labour. Thus the circumstances in which ergometrine overdose can occur still exist in many labour wards around the country. CONCLUSIONS: Despite the catastrophic initial presentation, the long-term prognosis after neonatal ergometrine overdose appears to be favourable. To prevent further cases of this life-threatening drug error, we recommend that administration of vitamin K be deferred until just prior to, or shortly after, transfer of the newborn infant to the postnatal ward.