FDA Prescribes Drug Testing On Kids

Many parents might be surprised to learn that the drugs that are prescribed for their children have never been tested on children. Now, the FDA has mandated that all new drugs undergo pediatric studies before being used on children. CBS News Health Contributor Dr. Bernadine Healy explains the changes, and offers information for parents who might consider allowing their children to participate in clinical trials.

In recent years, doctors have been prescribing more drugs for children to treat ailments such as depression, epilepsy, severe pain, gastrointestinal problems, allergic reactions and high blood pressure. Although all have been well tested in adults, these drugs have never been tested in children. Doctors have been determining the dosage for children based on experience and on the child's body weight.

The problem with this practice is that children are not just little adults. Their immature organs and different metabolic and immune systems can react very differently to drugs prescribed for adults. These drugs can carry the risk of unforeseen adverse reactions. In some cases, children may not be able to ingest even a portion of an adult drug.

Starting this December, a new FDA rule will mandate that any new adult drug that could be used in children with the same disease must undergo a pediatric study. The FDA expects more than 18,000 youngsters to participate over the next few years.

Despite the lack of pediatric studies, most drugs now on the market are known to be safe for use in children. Aspirin has been around for 100 years, and we know a lot about it. Ritalin has been around for 20 years and has been prescribed to millions of children. Although there's been no formal pharmacological testing of these drugs, a great deal of information has been acquired over time by their use.

In the past, doctors were reluctant to test drugs on children. They felt it was unethical to put children at risk, expecially since they cannot legally give consent. In any case, manufacturers had no incentive to study children because doctors legally can prescribe adult products to children. With stricter guidelines in place, many now feel clinical trials in children should be done to help doctors improve treatment.

These drug trials may be beneficial to young patients who are not responding to existing drugs. But parents need to make sure they fully understand the study and its risks.

If you consider enrolling your child in a study, find out who is running it. Pediatric specialty centers may get more careful oversight. Pediatric specialists also have the experience your child may need. If your child is going to participate in a test of a stomach drug, look for a pediatric gastroenterologist, who will be more likely to catch subtle signals of side effects in children, such as not playing or eating less. Also, ask about potential side effects from the drug and whether there will be lots of blood tests or any ain involved.

Don't get involved if the child objects. And don't be tempted by financial incentives. The only reason to participate in a clinical trial is if will help your child or others.