You may recall having seen television commercials that told us how “4 out of 5 dentists surveyed recommended a certain brand of toothpaste to their patients.” This message aired frequently for many years. Today, a similar commercial could very likely announce, “4 out of 5 doctors surveyed recommend untested, adult medication to their children patients.”

In the largest-ever U.S. pediatric study, new research confirms that nearly 4 out of 5 hospitalized children receive medications that have never been tested on children and in reality are approved “only for adults.” Prior to beginning their work, researchers had suspected that the so-called practice of "off-label” drug use was especially common with children patients. (“Off-label” refers to a drug prescribed to treat a condition for which it has not been approved by the US Food and Drug Administration.)

The study included looking into hundreds of thousands of patient records confirming their suspicions: Off-label drug use on children is rampant.

The extensive study was conducted by the Pediatric Health Information Systems Research Group under the direction of study leader Samir S. Shah, MD, a pediatrician at The Children’s Hospital of Philadelphia. Researchers analyzed patient records from 31 US children's hospitals for the entire year of 2004. They looked into the case records of more than 355,000 hospitalized children and published the following results in the Archives of Pediatrics and Adolescent Medicine.

• At least one drug was used off-label in 79% of the cases studied.
• Off-label drugs accounted for $270 million in drug sales.
• Some 40% of total dollars spent on children’s drugs was off-label.

The drugs most likely to be used off-label for children were those approved only for use on the central nervous system or the autonomic nervous system in adults. According to researchers, 28 percent of the children in the database received morphine, although the FDA has not approved it for children.

Least likely to be used off-label were anti-cancer drugs. This may have to do with the fact that anti-cancer drug testing usually includes children in clinical trials, according to researchers. Children were most likely to receive drugs off-label if they underwent surgery, were older than 28 days and had more severe illnesses.

The researchers pointed to the need for drug companies and the FDA to move forward with more testing and approvals. “With nearly 80 percent of children receiving off-label medications during hospitalizations, we need to focus our attention on the process by which medications are approved for pediatrics,” said senior study author Anthony D. Slonim, MD, executive director of the Center for Clinical Effectiveness at Children’s National Medical Center. “It is imperative that we thoroughly review this process to ensure that children are being treated with the safest, most effective therapies.”

Source: Children's Hospital of Philadelphia, March 2007. http://stokes.chop.edu/publications/press/?ID=341 and The World Chiropractic Alliance November 2007. http://www.worldchiropracticalliance.org/tcj/2007/nov/l.htm