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FDA Records of Infant Drug Deaths

Drug Reactions Caused Infant Deaths

WASHINGTON, D.C. -- November 22, 2002 -- Adverse reactions to drug treatments are a significant cause of death and injury in infants under two years of age, according to medical researchers at George Washington University and the University of Maryland (Pediatrics 2002 Nov; 110(5):e53). The group studied 500,000 reports by the Food and Drug Administration from November 1997 through December 2000. They found:

  • Children under two years old were named in 7,111 reports.
  • Among this age group, drug therapy was associated with an average of 243 deaths a year, with 41% occurring in the first month of life.
  • In 24% of cases of infant adverse reactions, the mother took the drug.
  • Only 17 drugs caused 54% of the most serious reactions in infants, and 4 drugs caused 38% of infant deaths.

The most dangerous drug linked to infant deaths was palivizumab, an antibody used for the prevention of severe respiratory virus disease in high-risk pediatric patients. Other drugs causing fatal reactions were nitric oxide, used in connection with mechanical ventilation in cases of respiratory failure, and indomethacin, an anti-inflammatory drug used in IVs for the reduction of hemorrhage. Cisapride (Propulsid), a treatment for severe heartburn, was also responsible for infant deaths. Propulsid's manufacturer withdrew the drug from the market in 2000 because of its links to heart rhythm disorders, other cardiac complications, and sudden deaths.

Adverse Drug Reactions Are Understated

The researchers pointed out that their estimate of the number of infant deaths and serious injuries was understated, citing FDA literature that places manufacturers' reporting of adverse drug reactions at only 15%. They recommended additional testing in young pediatric patients and greater care in the use of higher risk drugs for pregnant or lactating women.

At Brayton Purcell, we are concerned with injuries from unsafe drugs. If you have a question about your drug exposure or that of your child, please feel free to contact us to learn about your legal options.

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