Pediatric Drug Studies: Children Are Not Little Adults

More than half of the drugs approved every year that are likely to be prescribed to children are not adequately tested for use in children.

Vaccines and antibiotics are notably marketed with information for pediatric use, however many drugs, such as those for treating depression, epilepsy, severe pain, gastrointestinal problems, allergic reactions, and high blood pressure, do not contain any information for pediatric use. According to FDA estimates, more than half of the drugs approved every year that are likely to be used in children, are not adequately tested or labeled for treating children.

What’s the harm? Children have been harmed, and even killed, because of the lack of knowledge of how drugs might affect children. Children have immature organs and different metabolic and immune systems than that of adults. Therefore, children cannot be treated as little adults.

So, what is the FDA doing about this? The FDA finalized a rule in December 1998 requiring drug manufacturers to provide safety and efficacy information for pediatric use of their drugs, and provide labeling information on safe pediatric use. This is adequate for new drugs coming to market. However, drugs already on the market are exempt. The FDA can only require children’s studies in certain situations, such as when they believe that "significant risks" could be avoided.

The December 1998 rule expanded on a 1994 regulation that required drug manufacturers to look at existing data and determine if drug safety and efficacy in children could be supported. To avoid having to re-examine the safety and efficacy data, drug manufacturers just stated in their data that "safety and effectiveness has not been established for children". Yet some doctors continue to prescribe the drugs to children. And, it is legal for them to do so.

Is this all bad? No. There are some drugs, such as those for treating AIDS that may be beneficial to children even though they may not have been tested for safety and efficacy in children. Although the risks of prescribing the drugs are great, the alternative of not prescribing the drugs may be even greater. It places doctors in a tough situation.

What can you do to protect your child/children? Read the labeling and package inserts. Talk to your child’s doctor. There may be alternative treatments. Become an informed parent. Ask questions. Do your own research. Your children are depending on you to keep them safe!

Food and Drug Administration
Govenrment body responsible for regulating food, drugs and cosmetics.