Evaluation of the safety of short-acting nifedipine in children with hypertension

Abstract

Concerns regarding the safety of nifedipine emerged in 1995 with the report of an increased risk of myocardial infarction associated with adult patients receiving short-acting calcium channel blockers. There have been few case reports of adverse events in children. The purpose of this study is to investigate the effect on blood pressure (BP) and the incidence of adverse events associated with nifedipine in our pediatric population. We conducted a retrospective chart review of pediatric patients who received nifedipine. We recorded the dose administered, all BP measurements and all adverse events reported within six hours of a nifedipine dose regardless of the likelihood that those events were related to the nifedipine dose. 1,746 doses of nifedipine in 166 pediatric patients were reviewed. Systolic BP decreased by a mean of 17% and a maximum of 63%. Diastolic BP decreased by a mean of 28% and a maximum of 89%. Adverse events included: a) change in neurologic status, six cases; b) hypotension, two cases; c) oxygen desaturation, 16 cases. Neurologic events occurred in 33% of patients with acute CNS injury and 3.6% of all patients. Short-acting nifedipine is an important and effective oral antihypertensive agent which can be safely used for the treatment of hypertensive emergencies in children. It should be used with caution in children with acute CNS injury.

Ventricular arrhythmia following short-acting nifedipine administration

“…In two recent pediatric series, a significant percentage of children had a drop in blood pressure greater than 25% after short-acting nifedipine administration, demonstrating the unpredictable magnitude of the antihypertensive effect of this agent [7,8]. Adverse neurologic sequelae have also recently been reported in children treated with short-acting nifedipine [8,9].…”

“…Adverse neurologic sequelae have also recently been reported in children treated with short-acting nifedipine [8,9]. Finally, it is instructive to note that even the early descriptions of short-acting nifedipine use in children reported that the magnitude and duration of blood pressure reduction following administration of this agent were unpredictable [1].…”

“…On the other hand, in adults, short-acting nifedipine is now considered contraindicated in the treatment of severe hypertension due to well-documented adverse effects, including cerebrovascular ischemia, stroke, arrhythmias, hypotension and death [2,3,4,5,6]. Recently, however, several reports have appeared documenting either excessive drops in blood pressure [7,8] or adverse events in children treated with short-acting nifedipine secondary to the abrupt decrease in blood pressure [8] or the associated rebound hypertension [9]. We now report the development of a ventricular arrhythmia in an adolescent following short-acting nifedipine administration.…”

The safety and use of short-acting nifedipine in hospitalized hypertensive children

“…In addition, this report did not provide any other information such as adverse events. In another series by Egger et al [17], serious adverse events included change in neurological status, hypotension, and oxygen desaturation. However, the mean dosage utilized in this series was higher than in the present series (0.3 mg/ kg per dose versus 0.22 mg/kg per dose) with wider ranges in the former report (0.04-1.3 mg/kg per dose versus 0.04-0.67 mg/kg per dose).…”

“…In the 1996 recommendations from the Task Force Report on High Blood Pressure in Children and Adolescents, SA nifedipine continues to be recommended as a treatment for pediatric hypertensive emergencies [11]. Recent retrospective studies have suggested the safe use of SA nifedipine in pediatric hypertensive patients [16,17].…”