Most Drugs Prescribed to Children Have Never Been Tested on Children

A story initially appearing in the November 11, 2007 issue of the Baltimore Sun, titled, “Untested medicine” exposed the fact that, as author Stephanie Desmon stated in her article, “Most drugs given to children have never been tested for them, forcing physicians to sometimes use a best guess in determining dosing, efficacy and even safety.”

The article notes that children are not small adults and that their bodies’ process medications differently than do adults. Sometimes the medication goes into action faster and sometimes slower. The article also noted that some medications for adults are actually poisons for children. Dr. Joseph M. Wiley, chief of pediatrics at Sinai Hospital in Baltimore commented in the article how difficult it is to prescribe medication for children that has only been tested on adults, “If you extrapolate from an adult dose to a pediatric dose, you may be right … you may be wrong.”

Attempts to correct this problem have been made by laws being passed, however, the article notes that according to the Government Accountability Office, the investigative arm of Congress, that as of this year only about one-third of the drugs prescribed for children have been studied and labeled for pediatric use.

When studies were done it was found that the effects of drugs on children were much different than that on adults. Dr. Dianne Murphy, director of the Food and Drug Administration’s office of pediatric therapeutics, stated, “We found out that you can’t predict how kids are going to handle things.”

The article explained that once a medication has been approved for use in adults, it can then be legally prescribed to anyone at any age. The practice of prescribing drugs to groups it was not approved for is common and is known as “off-label” prescribing.

A study that confirmed this off-label use was published in the March 7, 2007 issue of the scientific journal the Archives of Pediatrics & Adolescent Medicine. In that study, referenced in the Baltimore Sun article they stated in their conclusions, “Most patients hospitalized at tertiary care pediatric institutions receive at least 1 medication outside the terms of the Food and Drug Administration product license. Substantial variation in the frequency of off-label use was observed across diagnostic categories and drug classes. Despite the frequent off-label use of drugs, using an administrative database, we cannot determine which of these treatments are unsafe or ineffective and which treatments result in substantial benefit to the patient.”