From Vincent Iannelli, M.D.,
Your Guide to Pediatrics.
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About.com Health's Disease and Condition content is reviewed by Kate Grossman, MD

Q. I noticed that the FDA just approved treating kids with Prozac. I am a bit surprised, as my child is taking Prozac already. Why was he prescribed a medicine that wasn't FDA approved to be used in children?

A. The Food and Drug Administration has recently approved the use of the antidepressant Prozac (fluoxetine) as treatment for children and adolescents 7 to 17 years of age with depression (major depressive disorder) or obsessive compulsive disorder (OCD).

This new indication follows studies that showed that Prozac was safe and effective for children with these disorders. But just because a medicine isn't FDA approved does not mean that it is not safe. It simply means that the drug company that makes the drug has not applied to the FDA for approval.

Many drugs are not FDA approved for use in kids, but are still used 'off-label', meaning that they are used in children younger that the approved age or for other conditions that they are not approved for yet. In fact, according to the American Academy of Pediatrics, 'three fourths of the prescription drugs currently marketed in the United States lack pediatric use information.'

This doesn't mean that it is not safe to use these medicines though. When deciding to use a medication 'off-label', a doctor should be making that decision 'based on sound scientific evidence, expert medical judgment, or published literature.' It is not like your doctor is experimenting with your child.

The use of albuterol to treat children with asthma is a good example of the safe 'off-label' use of a drug. Although commonly used in infants and toddlers, albuterol is only FDA approved for use in children over age 2 years. Many other asthma medications, such as Flovent, Serevent, and Advair are only FDA approved for use in children over age 12 years.

Why are these medications used if they are not FDA approved?

In the case of these asthma medications, there are no other medications to use and these medicines have been used so much, they are thought to be safe and studies have shown that they work. And the alternative, not treating or preventing children's asthma symptoms, would not be acceptable.

The same is true for depression, a common problem in children. The 'off-label' use of newer antidepressants, such as Prozac, Celexa (citalopram), and Zoloft (sertraline), is generally thought to be safer than not treating children's psychiatric symptoms. And there are many studies that show these medications are safe.

For Celexa, one study:

Citalopram treatment for impulsive aggression in children and adolescents: an open pilot study. Armenteros JL - J Am Acad Child Adolesc Psychiatry - 01-May-2002; 41(5): 522-9

concluded that it 'appears to be effective and well tolerated in this sample of children and adolescents with impulsive aggression.'

Zoloft is also thought to be safe in children, and is approved for treating children over age 6 years with obsessive compulsive disorder.

Allergy and reflux medications are also commonly used off-label.

According to a 1994 report, 10 drugs were prescribed more than 5 million times in a single year to children in age groups for which the drugs were not adequately labeled, including:

• 349,000 prescriptions of Prozac to children under 16
• 248,000 prescriptions of Zoloft to children under 16
• 226,000 prescriptions of Ritalin to children under 6
• 325,000 prescriptions of Lotrisone to children under 12