Inadequate Drug Safety Testing—Children Injured by Medication

Medical Malpractice Appeals

Please visit the official website for the Food and Drug Administration for more information on this issue. Special thanks to the personal injury lawyers of Price Benowitz LLP for their insights and contribution to this post.

Some of the medical profession’s most vulnerable patients are young children,
particularly newborns. Often treated in the neonatal ICU, hospitalized newborns
are incredibly susceptible to drug errors. Nevertheless, a recent study found that
while in recent decades some progress has been made relative to the use of “adult”
drugs in older children, an alarming 90 percent of medications used in newborns in
Virginia have not gone through adequate safety studies.

The United States Food and Drug Administration’s Office of Pediatric Therapeutics
study recently evaluated labeling information on drugs used in children by
examining those listed for usage in children in the Physicians’ Desk Reference.
The results they discovered are concerning, according to Fairfax County child
medication injury attorneys. The study found that only about half of all medications
used in children contain label information about drug effectiveness, safety or dosing
in children. Researchers looked at over 500 medications in the Physicians’ Desk
Reference (PDR), some not used in pediatrics, and found that less than 50 percent
referred to use in children. Next, researchers focused only on drugs that referred
to usage in children, and found “adequate” labeling information for 231 of 461
drugs. “Adequate” in this context means that labeling information, relative to a
drug’s use in kids and teens, included effectiveness and dosing information. This,
however, does not address the vulnerabilities in Virginia’s youngest patients.

Furthermore, physicians and researchers are now beginning to understand that
children, especially the very young—including newborns—are not simply miniature
versions of adults. Their diseases, while similar, may have different underlying
causes, and they may metabolize and react to drugs differently, and they also have
underdeveloped immune systems in comparison to adults.

Progress that has been made in child drug testing and safety is due in large
part to two laws that went into effect, respectively, in 1997 and 2003: The Best
Pharmaceuticals for Children Act (BPCA), and the 2003 Pediatric Research Equity
Act (PREA). High drug development costs, however, deter many, if not all, drug
makers from not only developing pediatric formulations, but also from adequately
testing their drugs for child safety. Thus, with reauthorization of these laws due this
year, medical professionals are asking that regulations be strengthened and address
newborn patient vulnerabilities.

BPCA and PREA have been exceedingly successful in improving medical care for
children by driving research to create innovative medicines for use in pediatric
patients,” says Pharmaceutical Research and Manufacturers of America Senior Vice
President for Scientific and Regulatory Affairs Dr. David E. Wheadon. “Prior to their
passage, roughly 70 percent of medicines taken by children lacked pediatric dosing
information. As of 2008, thanks to BPCA and PREA, between 50 percent and 60
percent of medicines have been studied in some part of the pediatric population.