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Adverse Drug Reaction following Injection of Amikacin Sulphate in a Cluster of Preterm Newborns |
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Jayesh Varia, Rajiv Prasad, Vandana M Desai, Vasav D Desai 1. Resident, Department of Pediatrics, SMIMER, Surat, Gujarat, India. 2. Associate Professor, Department of Pediatrics, SMIMER, Surat, Gujarat, India. 3. Professor and Head, Department of Pediatrics, SMIMER, Surat, Gujarat, India. 4. Resident, Department of Pediatrics, SMIMER, Surat, Gujarat, India. |
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Correspondence Address : Dr. Jayesh Varia, Resident, Depatment of Pediatric, SMIMER Hospital, Sahara Darwaja, Umarwada, Surat-395010, Gujarat, India. E-mail: jayesh.variya123@gmail.com |
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| ABSTRACT |  | ||||||||||||||||||||||||
: Although, single case reports regarding adverse effects of Inj. Amikacin sulphate in newborns have been published, simultaneous affection of multiple babies is rare. In this report we present cluster of newborns admitted in a neonatal intensive care setup presenting with Adverse Drug Reaction (ADR) to Inj. Amikacin sulphate. It can cause life threatening adverse effects and neonates are particularly vulnerable to ADR. | |||||||||||||||||||||||||
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| Keywords : Adverse drug reaction, Amikacin sulphate, Neuromuscular blockade, Preterm newborns | |||||||||||||||||||||||||
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DOI and Others :
DOI: 10.7860/IJNMR/2017/27702.2217
Financial OR OTHER COMPETING INTERESTS: None. Date of Publishing: Oct 01, 2017 |
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| Case Report |
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ADR with Inj. Amikacin sulphate has been reported in many cases but is rarely serious. In our literature search, we did not found any report of a cluster of cases with ADR to Injection Amikacin sulphate. Hence we are reporting this cluster of newborns who simultaneously developing ADR in NICU setup. A cluster of preterm low birth weight newborns admitted in a Neonatal Intensive Care Unit (NICU) in a Medical College setup developed severe ADR after administration of the night dose of antibiotics. The details of the event are as follows: 13 babies were on Injection Amikacin sulphate (15 mg/kg/day in 2 divided doses) in the NICU of our Tertiary Care Hospital as per protocol for neonatal sepsis (1). The nurse in charge of administration of antibiotic injection in NICU prepared the doses as per the NICU protocol for the night dose [2,3]. During the administration of the drugs when the sixth baby was injected, the mother of the baby who had received the first dose of Injection Amikacin sulphate complained that her baby has become lethargic and had bluish discolouration of the whole body. As the NICU staff attended the first baby, the other four babies also started developing similar symptomes. Immediate assessment and management of all 5 babies was initiated. The sixth baby was already on ventilator support and developed only transient cyanosis hence we could not exactly define whether the baby had suffered an ADR. There after Inj. Amikacin sulphate was stopped for all remaining babies in NICU and batches of other the antibiotics being administrated simultaneously viz. Inj. Piperacillin/tazobactum (300 mg/kg/day in 3 divided doses) and Inj. Cefotaxime (100 mg/kg/day in 2 divided doses) were substituted. Later on, after change of antibiotics, no further adverse events were reported. There were two pairs of preterm twins among the 5 babies. i.e., first pair was case 1 and 2. Second pair was case 4 and 5. Case 3 was preterm baby from single pregnancy. Details of the cases has been described in (Table/Fig 1). Common antibiotic being administered to all babies was Inj. Amikacin sulphate. All 5 babies were vitally stable and none of them had any history of apnoeic spells before the adverse event. Twin pair 1 and case 3 developed cyanosis, hypotonia, bradycardia while twin pair 2 also developed pallor and mottling along with the aforesaid symptoms. ADR was reported to pharmacovigilance program and antibiotic samples were sent to FDA for analysis which was reported as normal. | |||||||||||||||||||||||||
| Discussion |
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An ADR has been defined by the World Health Organization (WHO) as ‘any noxious or unintended drug response at doses commonly used for prophylaxis, diagnosis or treatment of a disease or condition (4). Neonatal clinical pharmacology aims to assess inter and intra individual variability among different subjects and by that to predict and estimate adverse effects at the level of the population or preferably, the individual infant [5,6]. In recent studies related to iatrogenesis in NICUs, 33% cases were preventable, of which about 25% were related to medical errors [7,8]. Differentiation of ‘true’ ADRs from confounding reactions associated with organ dysfunction, immaturity and underlying diseases remains difficult. New ADR assessment score [Table/ Fig-2] is more valid and reliable as compared to the Naranjo algorithm, ADR assessment score is based on 13 simple yet informative questions [8,9]. Ototoxicity, nephrotoxicity and neuromuscular blockade are known adverse reactions of Amikacin sulphate (10). Calcium transfer from mother to fetus takes place mainly in last trimester, so preterm babies are prone to hypocalcemia and they have high chances of neuromuscular blockade (11). In this case report, primary evaluation suggested adverse reaction to Inj. Amikacin sulphate based on the ADR assessment score which was 22 for each of the babies thus falling in “Definite ADR” category. All the babies had the same score since they had similar background of predisposition and epidemiology. This ADR is likely to be due to neuromuscular blockade action of Amikacin sulphate. Once this drug was withdrawn and antibiotic was changed, no further adverse event occurred which further supports the possibility of ADR. Since, all the babies in the cluster of babies reported by us were preterm and the literature clearly mentions prematurity to be a risk factor for ADR, in this event prematurity was no doubt a significant predisposing factor. However, since the event involves a single episode which was in the backdrop of no unusual or new methodology of drug preparation or administration and the process of preparation of actual injection is not monitored, it is not possible to establish the actual reason which may have precipitated this crisis. | |||||||||||||||||||||||||
| Acknowledgement |
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We would like to thank Administration of SMIMER and Surat Municipal Corporation for their support and guidance. | |||||||||||||||||||||||||
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