Drugs can be deadly in children under two

According to an analysis of cases recently reported to the Food and Drug Administration, medications used to treat either a mother or child played a role in serious side effects and deaths in children under 2 years of age. There were 6,000 serious side effects of drugs, including 769 deaths, in children under 2 years of age in the US between 1997 and 2000. Medications given to pregnant or breast-feeding women may have caused a large proportion of adverse events, and just four drugs were the principal suspect in more than one third of all the reported deaths. The drugs suspected as a cause of serious and deadly reactions when administered directly to children included treatments for respiratory syncytial virus (RSV), antibiotics and analgesics, such as acetaminophen and ibuprofen. Infection with RSV is common, and most people are infected by age 2 and experience cold-like symptoms that eventually improve without treatment. In the study, researchers from the Washington University in Washington DC analysed over 7,000 reports of adverse drug reactions in children under age 2 received by the US Food and Drug Administration from November 1997 through December 2000. Overall, 5,976 reports were new and unique cases that had not been reported previously. Drug therapy was associated with an average of 243 reported deaths annually over the 38-month study period, with 100 (41%) occurring during the first month of life and 204 (84%) during the first year. In 1432 (24%) reported adverse event cases of all levels of severity, exposure to the drug was from the mother during pregnancy, delivery, or lactation. Overall, the investigators identified 1,902 drugs, chemicals, biological products, vaccines, over-the-counter medications, vitamins, minerals, dietary supplements and other substances in the reports, but just 17 drugs were indicated in more than half of the serious side effects or deaths in children given medication directly. The vast majority of deaths (84%) happened before the infant's first birthday. Adverse reactions to drug therapy are a significant cause of death and injury in infants and children under 2 years of age. Drugs administered to the mother in the perinatal period constituted a major route of exposure to adverse drug advents. The results of this study underscore the need for additional testing in the youngest paediatric patients and for greater vigilance in the use of higher risk drugs and in medication for pregnant and lactating women. However these reports do not prove that the suspect drug directly caused the reported adverse event. Instead they should be considered as a warning flag to examine those drugs more carefully.