Medicines Control Council, National Adverse Drug Event Monitoring Centre,

South African Medical Journal (SAMJ)

another agenda, but it was at the end of the day and mysuperbly tuned incisive diagnostic skills were not at theirsharpest. We ended on that note and as he got to the door hesaid, as an aside, ‘I believe there is a pill for it nowadays’.  Iknew intuitively exactly what he was talking about. He wasreferring to Viagra and we went on to raise the subject, so tospeak.My most recent door-handle symptom involved a man withsores on his arms and legs.  I explained that they were Natal orveld sores and were caused by bacteria.  I prescribed antibioticsto take by mouth and a nasal cream, which I explained was tokill the reservoir of organisms in his nose.  As he went out ofthe door he hesitated and said ‘do you think I should have anAIDS test?’. I asked why he thought this was necessary. Hereplied that a worker in his factory had just died of AIDS andhis symptoms had started with skin sores.  I had treated hiscondition, but I had completely missed his reason for comingto see me.December 2004, Vol. 94, No. 12  SAMJSAMJ FORUM952The National Adverse Event Monitoring Centre (NADEMC)of the Medicines Control Council wishes to draw theattention of health practitioners to the fact that Naropin(ropivacaine) is not approved for use in children under 1year of age, as safety and efficacy in this population havenot been established.For paediatric use ropivacaine is approved for acutepain management using caudal epidural or peripheralnerve block in the pre- and postoperative setting.1 Safetyand efficacy have not been established in children under theage of 1 year.  The package insert gives no dose for childrenunder 1 year of age.The NADEMC has a total of 21 adverse reaction reportswith 47 adverse reaction terms in its database whereropivacaine is indicated as the medicine suspected to havecaused the event. Three of these reports followed the use ofropivacaine in infants less than 1 year of age:• A 2-month-old male infant (2.1 kg) was given a caudalblock with ropivacaine, and 13 minutes later developedapnoea, bradycardia and pallor. He responded totreatment with oxygen and atropine. He required nofurther treatment apart from tactile stimulation andaminophylline. This infant had been born at 28 weeks’gestation and had a history of apnoeic spells.• A 2-month-old male infant (2.5 kg) experienced apnoeafollowed by bradycardia and cyanosis 5 minutes afterropivacaine administration for caudal block. Herecovered on treatment. The infant had been bornprematurely, but had no history of apnoea.• A 6-month-old infant (7.8 kg), treated with ropivacainefor postoperative analgesia by epidural infusion over 2days, was noted to be jittery with continuous abnormalmovements of the upper limb, which were morepronounced when he was awake. The symptoms slowlyresolved after the infusion was stopped. Analysis ofblood samples showed ropivacaine levels below thoseexpected to result in systemic toxicity based on findingsin adults.In all three cases the events were assessed as possiblyhaving been causally associated with Naropin because ofthe temporal relationship to its administration. The role ofother causes, including the clinical status of the infants,could not be excluded.The systemic toxicity of local anaesthetics, includingropivacaine, mainly involves the central nervous system(CNS) and the cardiovascular system. Excitation of the CNSmay be manifested by restlessness, excitement, nervousness,paraesthesiae, dizziness, tinnitus, blurred vision, nauseaand vomiting, muscle twitching and tremors, andconvulsions. Excitation may be transient and followed bydepression with drowsiness, respiratory failure and coma.Cardiovascular system effects of local anaesthetics includemyocardial depression and peripheral vasodilatationresulting in hypotension and bradycardia, arrhythmias andcardiac arrest.Health care professionals are requested to report anysuspected reactions associated with the use of Naropin orany other medicines to the National Adverse Drug EventMonitoring Centre at (021) 447-1618, fax (021) 448-6181.National Adverse Drug Event Monitoring CentreMedicines Control Council1. Sweetman C, Blake PS, eds. Martindale: The Complete Drug Reference. 33rd ed. London:Pharmaceutical Press, 2002.Naropin: Safety and efficacy not established in childrenunder 1 year of ageDRUG ALERT

Naropin: Safety and efficacy not established in children under 1 year of age

http://samj.org.za/index.php/samj/article/download/2813/2015

Naropin: Safety and efficacy not established in children under 1 year of age

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South African Medical Journal (SAMJ)