|
Event verbatim [preferred term] (related symptoms if any separated by commas).Grown 5, 5 cm in 6 months [growth accelerated].Misuse: the cartridge 10 mg used with nordipen 5 mg [drug administered in wrong device].Patient was systematically received a double dose [overdose].Case description: this serious spontaneous case from (b)(6) was reported by a medical doctor as "grown 5, 5 cm in 6 months" beginning on 2016, "misuse: the 10 mg cartridge was used with nordipen 5 mg pen" beginning (b)(6) 2015, "patient was systematically received a double dose" and concerned a child male patient who was treated with norditropin simplex 5mg (somatropin) from unknown start date due to "growth hormone deficiency" and nordipen 5 (device) from unknown start date due to "growth hormone deficiency".Medical history included growth hormone deficiency since 2010 and panhypopituitarism as congenital form with choanal atresia.Height, weight and body mass index (bmi) were not reported.On (b)(6) 2015 at the last consultation, the physician (reporter) proposed to replace nordipen 5 mg by norditropin nordiflex 10 mg with the same dose 0.5 mg daily.The patient's family preferred to keep the old pen used with norditropine simplex 5 mg.The pharmacist had dispensed norditropin simplex 10 mg as per prescription and did not check the number of dispensed cartridges which was very important.The patient's family was receiving 3 cartridges of 10 mg per month instead of one cartridge of 10 mg each 20 days from the pharmacy.The patient used norditropin simplex 10 mg with nordipen 5 mg and therefore systematically received a double dose (1 mg) daily that corresponding to 0.052 g/kg daily during 6 months.The physician noticed that the patient presented very marked prognathism.The patient increased regularly shoe size and especially grew 5, 5 cm in 6 months.On (b)(6) 2016, during the last consultation, the usual dose was re-established to 0.5 mg (0.026 g/kg daily) with the correct pen.Nordipen 5 was replaced by the correct pen norditropin nordiflex 10 mg.Laboratory results available: igf = 278 ng/ml normal range > 270, both the glycaemia and insulinemia were normal.In conclusion, the pharmacist had dispensed a large amount of cartridges based on the prescription of the physician's (for use with the pen nordipen 10 mg).The patient's parents decided to keep using the old pen nordipen 5.So the patient received double dose during 6 months and presented significant development disorder probably due to this overdose.However, igf1 level was normal.The case was initially reported by a sales rep on behalf of a physician on 23-jun-2016.Action taken to norditropin simplex 10 mg was dose decreased.Action taken to nordipen 5 was product discontinued.The outcome for the event "grown 5, 5 cm in 6 months" was unknown.The outcome for the event "misuse: the cartridge 10 mg used with nordipen 5 mg" was recovered.The outcome for the event "overdose" was recovered.This case was re-classified from non-serious to serious on 04-jul-2016 by the patient's medical doctor.
|
|
Event verbatim [preferred term] (related symptoms if any separated by commas)0 grown 5, 5 cm in 6 months [growth accelerated]; misuse: the cartridge 10 mg used with nordipen 5 mg [drug administered in wrong device]; patient was systematically received a double dose [overdose]; the pharmacist had dispensed norditropin simplex 10 mg and did not check the number of dispensed cartridges [drug dispensing error].This serious spontaneous case from (b)(6) was reported by a medical doctor as "grown 5, 5 cm in 6 months" beginning on 2016, "misuse: the cartridge 10 mg used with nordipen 5 mg" beginning on (b)(6) 2015, "patient was systematically received a double dose" beginning on (b)(6) 2015, "the pharmacist had dispensed norditropin simplex 10 mg and did not check the number of dispensed cartridges" with an unspecified onset date, and concerned a child male patient who was treated with norditropin simplexx (somatropin) from unknown start date due to "growth hormone deficiency", , nordipen 5 (device) from unknown start date due to "growth hormone deficiency", the pharmacy dispensed by mistake a wrong product to the patient.Laboratory results available: igf = 278 ng/ml normal range > 270, both the glucose and insulin levels were normal.On (b)(6) 2016 it was confirmed, that this was a mistake by the pharmacist who didn't deliver the corresponding pen nordipen 10 and who didn't checked the amount of mg dispensed per month (twice more).After the physician discovered the problem, he asked the patient to use the correct pen nordiflex 10 mg in order to avoid a similar mistake.Action taken to norditropin simplex 10 mg was product discontinued.Action taken to nordipen 5 was product discontinued.The outcome for the event "grown 5, 5 cm in 6 months" was unknown.On (b)(6) 2016 the outcome for the event "misuse: the cartridge 10 mg used with nordipen 5 mg" was recovered.On (b)(6) 2016 the outcome for the event "patient was systematically received a double dose" was recovered.The outcome for the event "the pharmacist had dispensed norditropin simplex 10 mg and did not check the number of dispensed cartridges" was not reported investigational results: novopen 5: no investigation was possible, because neither sample nor batch number was available.Norditropine® simplexx® 10 mg/ 1,5 ml, solution injectable: no investigation was possible, because neither sample nor batch number was available.Since last submission of the case, the following has been updated: added additional event to reflect the drug dispensing error, detailed course of event, narrative updated accordingly, manufacturer's comment updated.Company comment: this single case report is not considered to change the current knowledge of the safety profile of the suspected drug.Manufacturer's final comment: on (b)(6) 2016 nordipen 5 has not been returned to novo nordisk a/s for investigation, batch no.Is unknown and no investigation is possible.The patient was treated with norditropin simplex 5mg with nordipen 5.Nordipen 5 was used with the new proscribed medication - norditropin simplex 10 mg and get an overdose for a period of half a year.When the mistake was identified this has been corrected.In the instruction for use is specifically emphasised that patients should only use norditropin simplex strength which matches to the colour and strength of the pen.In this case this has not been followed.It was confirmed that dispensing error occurred.It was not possible to find similar reportable incidents to the one reported in argus case (b)(4).Evaluation summary: no investigation was possible, because neither sample nor batch number was available.No investigation 2 reason for no investigation choice no sample or batch no.Are available : no investigation possible no investigation 2 investigation links: batch trend report links ccc comments attachments investigation results no investigation was possible, because neither sample nor batch number was available.Investigation results lookup result codes general : no sample available remarks for result codes conclusion code no sample root cause description corrective action description no investigations - no corrective actions.
|
