Spontaneous Adverse Drug Reaction Reports for Neonates and Infants in the Uk 2001–2010

Abstract

AimsThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme [YCS]) to collect ‘suspected' adverse drug reaction (ADR) data. We aim to describe the Yellow card reports received for patients aged ≤1 year for a 10 year period and assess their utility.MethodsData on all ADRs reported via the YCS in Infants aged ≤1 years from the years 2001–10 were supplied by the MHRA.ResultsIn total, 3217 suspected ADRs were reported to the YCS between 2001–10 for infants age ≤1 year (Neonates n=97, vaccinations n=2673, infant [neither neonate nor vaccine] n=477). Overall only 0.88 YC per day were received by the MHRA with a male preponderance (Male 50.3%, Female 45.7%); only 25 (0.8%) YC reports stated a gestational age for the affected infant. The medications most frequently reported as suspected of causing an ADR were Swine Flu Vaccine (neonates n=8), Neisseria meningitides (vaccinations n=693) and oseltamivir (infants n=37). Reports associated with vaccinations followed the expected trends. ADRs highlighted by regulators for neonatal and infant populations are not represented in the YCs received by the regulator.Conclusions The frequency of YCS reports for those ≤1 year is low, with less than 1 per day overall. Neonates are poorly represented, and recording of gestational age is very limited. The YCS appears to be more effective for spontaneous reporting of vaccination-related ADRs in infants than for other medications. Action is required to improve reporting of suspected ADRs that affect neonates and infants.

Efficacy, Retention and Tolerability of Everolimus in Patients with Tuberous Sclerosis Complex: A Survey-Based Study on Patients’ Perspectives

“…Comparable to previously reported retrospective studies, over 70% of patients in our study reported EVE-related AEs, which were more frequently reported (80%) among the adult cohort than among children and adolescents (59%) [18,57,81]. In addition to a potential increased willingness to report AEs among adult patients, the underestimation of AEs among children and adolescents due to by-proxy recording of AEs based on the responses of parents and guardians may be a factor in this difference, although this appears to be unlikely according to the literature [82,83]. In line with the most pivotal and post-marketing studies, frequently reported AEs included stomatitis, symptoms of immunosuppression, trivial infections and an acne-like rash [17,18,51].…”