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Vaccines and paediatric ADRs

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Br J Clin Pharmacol 2012;73:437-446

Vaccines are the therapeutic class most commonly linked to paediatric adverse drug reactions (ADR), according to an analysis of Yellow Cards. The study also found that ADR reporting by nurses increased dramatically in recent years.

On average, the MHRA receives 2,146 ADR reports a year concerning children, around 14 per cent of yellow cards. Between 2000-2009, reports mentioned 18 vaccines and 152 medicines. Headache (10 per cent), dizziness (9.3 per cent) and pyrexia (7 per cent) were the most frequently reported symptoms.

Vaccines were included in 66.5 per cent of paediatric ADR reports, reflecting their 'high usage compared with medicines'. Meningococcal Serogroup C conjugate was the most frequently implicated vaccine (38.2 per cent of Yellow Cards), followed by HPV (7.8 per cent) and BCG (4.1 per cent).
Methylphenidate (2.1 per cent), atomoxetine (1.5 per cent) and valproic acid (0.8 per cent) were the most commonly reported drugs.

The proportion of Yellow Cards completed by nurses rose from 23.5 per cent of paediatric ADRs in 2001 to 41.8 per cent in 2009. Reporting by doctors and pharmacy teams remained comparatively constant.

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