Dr. Henry Paul, MD

Psychiatrist, Author and Educator

ARE TOO MANY CHILDREN TAKING PSYCHIATRIC MEDICATIONS OFF-LABEL AND WHAT DOES THAT MEAN?

January 9th, 2014

Using drugs “off-label” for treating all kinds of conditions from cancer to ADHD has become so common that almost every drug at some point is prescribed off-label. “Off-label” means the medication is being used in a manner not specified in the FDA’s approved packaging label, or insert. Off-label prescribing isn’t necessarily bad. It can be beneficial.

In child and adolescent psychiatry, the majority of the drug prescribing is done off-label. Few medications are approved for young people, but making these valuable medications unavailable because drug companies have not tested them for all conditions and populations would cause a lot of prolonged suffering and even deaths. This is the case for hundreds of drugs, not just psychotropics. Studies have been coming out showing the helpfulness of psychotropic medication in young people and hopefully science and research will continue to catch up with clinical reality.

All in all, there are about ninety common psychotropic medications in common use today. The highest rate of approved drugs for use in children is in the area of stimulants used for ADHD. In that category, 100 percent of the drugs are approved for young people. In the antidepressant category, there are about thirty compounds altogether, seven of which are approved for use in children. In the antipsychotic category (most of these drugs are used for behavior control), there are fewer than twenty compounds with seven approved for children. There are no officially approved drugs for the treatment of anxiety in children and teens, and for mood stabilization (bipolar children) six medications are approved, mainly for teenagers only.

So, yes, child and adolescent psychiatrists routinely prescribe off-label, but we know that what we are prescribing works. Although there have been outcries against any off-label drug use because of possible dangers, the other side of the argument is that millions of people would be hurt if medication were withheld. When it comes to children, the outcry is even louder since the vulnerability is assumed to be greater with a younger and more physically and mentally immature population. But despite the many Internet tales of children being harmed by off-label prescribing, there are few reports in professional journals of its particular danger.

Presently about one million antidepressants prescriptions are written yearly in the United States for young people. This number has quadrupled in the last several years. In general, antidepressants are used off-label in treating children except for the following:

  • Prozac approved for depression in children eight years old and over for depression;
  • Anafranil approved for children ten years old and older but for Obsessive Compulsive Disorder only;
  • Lexapro approved for twelve to seventeen year olds for depression;
  • Luxox approved for eight year olds for Obsessive Compulsive Disorder only;
  • Sinequan approved for twelve year olds for depression;
  • Tofranil approved for six years old and over for bedwetting only;
  • Zoloft approved for six year olds for Obsessive Compulsive Disorder only.

Many people do not realize that the FDA regulates drug approval, not drug prescribing, and doctors are free to prescribe a drug for any reason they think is medically appropriate. For this reason, few patients are aware they are receiving a drug off-label since doctors are not required to tell a patient that a drug is being used that way. If you are concerned about a drug that is being prescribed for your child, by all means, ask the doctor about it.

DISCLAIMER
Information contained in this blog is intended for educational purposes only. It is not intended as medical or psychiatric advice for individual conditions or treatment and does not substitute for a medical or psychiatric examination. A psychiatrist must make a determination about any treatment or prescription. Dr. Paul does not assume any responsibility or risk for the use of any information contained within this blog.