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(The Best Years in Life ) 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:
According to the study, the World Health Organization defines adverse drug reaction (ADRs) "...as events related to a medication that are noxious, unintended and occur at normal doses used in humans for prophylaxis, diagnosis or therapy of disease, or for modification of physiological function." Their definition excludes accidental or deliberate excessive dosage or maladministration. The global problem with ADRs is so serious that, according to the study, "ADRs are one of the leading causes of morbidity and mortality in many countries , ." Indeed, a 1998 report published in JAMA found that 106,000 Americans die every year from correctly prescribed medications.
The study results showed concerning patterns, across both age and gender.
In interpreting the results, one explanation offered by the authors for the fact that 50% of the ADRs were reported for children from birth to 5 years of age, with close to 40% affecting children between 2 months and 2 years of age, was "Children under 5 were the most common age group for vaccination."
They expanded on this explanation further:
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