Reported paediatric adverse drug reactions in the UK 2000-2009.

AIMS: The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme) to collect 'suspected' adverse drug reaction (ADR) data. MHRA advice is to report all suspected ADRs in paediatric (<17 years) patients. METHODS: Data on all ADRs reported to the MHRA in patients <17 years from the years 2000-9 were supplied in two datasets, inclusive and exclusive of vaccines. RESULTS: Of 222 755 ADR reports received by the MHRA from 2000-9, 31726 (14.2%) were in children <17 years. The number of reports in 2000 was greater than in subsequent years (12035) due to a national vaccination programme (Meningococcal Serogroup C conjugate vaccine). The median number of ADR reports per annum (2001-2009) for children was 2146 (95% CI 1801, 2575). Vaccines were included in 22102 (66.5%) paediatric ADR reports, with Meningococcal Serogroup C conjugate vaccine reported most frequently (12106 reports) and headache the commonest symptom (3163). Excluding vaccines, methylphenidate (653 reports) and atomoxetine (491) were the most commonly reported medications, and the most commonly reported symptom was vomiting (374). Reporting by nurses increased from 396 in 2001 to 1295 in 2009 (41.8% of all reports); reporting by doctors stayed constant. Reports from patients, parents or carers more than doubled but remained infrequent (1.5% in 2005, 4.0% in 2009). CONCLUSIONS: Although under-reporting is probably common, the Yellow Card Scheme in the UK receives more than 2000 reports per year on patients <17 years. Nurses now report more suspected ADRs in children than any other healthcare professional.

Is there a role for erythropoietin in neonatal medicine?

Since it was first cloned in 1985, the therapeutic potential of recombinant human erythropoietin in the neonatal hyporegenerative anaemias has been studied-the anaemia of prematurity and haemolytic disease of the newborn. Between 60% and 100% of preterm infants are transfused before three weeks of age, a large proportion receiving more than one transfusion. Blood transfusions are currently also the mainstay of treatment for the hyporegenerative anaemia encountered in neonates with Rhesus disease. Sometimes the situation is complicated by the religious beliefs of the parents. Blood transfusions are associated with numerous risks, from transmission of infection to local injury, and in an effort to minimize these risks Neonatologists have looked to recombinant erythropoietin. Despite an extensive number of studies, there is as yet no clear consensus as to whether the use of recombinant erythropoietin in Neonatal medicine minimizes the need for blood transfusions without risk to the neonate. In this article we review the evidence for and against the use of recombinant erythropoietin in Neonatal medicine.