A groundbreaking new drug safety study published in the open access journal PLoS and titled, “Adverse Drug Reactions of Spontaneous Reports in Shanghai Pediatric Population,” has revealed for the first that that 42.5% of all reported adverse drug reactions occurring in 2009 in a Chinese pediatric population (Shanghai, pop of 17 mil) were caused by vaccines, with reactions as severe as anaphylaxis and death.
The report carries unique gravitas insofar as the data was gathered through spontaneous reports of physicians (52.03%), pharmacists (24.27%) and other health care practitioners (15.46%), with only 2.52% coming from ‘consumers.’ Presumably, the clinical training of those reporting gives the study additional credibility.
According to the study, which is one of the first ever conducted on the topic in China, “Knowledge of drug safety in the pediatric population of China is limited. This study was designed to evaluate ADRs in children reported to the spontaneous reporting system (SRS) of Shanghai in 2009.”
The results of the study were reported as follows:
“A male overrepresentation was observed regarding the total number of reports. The most frequently reported group of drugs were vaccines (42.15%). Skin rash and fever were the commonest symptoms reported in the total pediatric dataset. The proportion of children that suffered from a serious ADR was 2.16% and that for drug related deaths was 0.34%. And we found that the multiple drug exposure experienced a high proportion of serious ADRs compared with the single drug use (χ215.99, P<0.0001). Sixty-five percent of ADRs were for children less than 6 years of age. And more than half of reports were from doctors.”