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Background & aims The Medicines and Healthcare Regulatory Authority (MHRA) in the UK runs a national spontaneous reporting system (Yellow Card Scheme) to collect ‘suspected’ Adverse Drug Reactions (ADRs) for all medicines. To increase the data for paediatric medicines, current MHRA advice is to report all suspected ADRs in paediatric patients. Yellow Cards submitted between 2000 and 2009 were analysed for medications commonly used in paediatric rheumatology. Methods Data on all UK spontaneous ‘suspected’ ADRs reported to the MHRA in patients <17 years from the years 20009 were supplied. Data included age, type of reaction, medication and type of reporter, but were unlinked. Data were only supplied on an individual drug if five or more suspected ADRs were reported in a calendar year. The cut-off values in the data supplied were in accordance with policy guidelines applied by the MHRA to preserve confidentiality of reporters and patients.

Reports to the UK Yellow Card Scheme 2000-2009 for medications used in paediatric rheumatology