What FDA approved medicines treat bipolar in children and teens?

Dr. Michael Roizen, MD
Internal Medicine

NONE. That is, as of right now, there are no approved medications for children under the age of 10. That being said, the FDA approves the use of lithium in children aged 12 to 17. Abilify and Risperdal (antipsychotics) have FDA approval for use in children aged 10 to 17. The use of anticonvulsants such as Depakote and Topamax are not FDA approved for use in children with bipolar disorder. Furthermore, antidepressants are used with extreme caution in children because of the risk of suicidal thoughts. Your child’s doctor will know which medications will be the safest and most effective treatment options for your child.

Mark Moronell, MD
Cardiology (Cardiovascular Disease)
The FDA has approved medications for teenagers with bipolar disorder. Other medications that are used for treating bipolar disorder are used "off label". This means the medications are not approved by the FDA for this use. The FDA has approved drugs used in short-term clinical trials. This means researchers still do not know the full impact of long-term use of medications used to treat teens with bipolar disorder. Some of the drugs approved for use in teens, ages 13 to 17, include atypical antipsychotics such as aripipazole (Abilify), quetiapine (Seroquel) and risperidone (Resperidol). The FDA has also approved the use of olanzapine (Zyprexa) for teens ages 13 to 17 with bipolar 1 disorder. Bipolar I symptoms include major depression and mania, while bipolar II symptoms include major depression and hypomania. Lithium is a mood stabilizer approved by the FDA for teens ages 12 to 17. While anticonvulsants (Depakote and Topamax) are used for teens, these drugs are not FDA approved for use in youth with bipolar disorder. Recently, the FDA has put a warning on antidepressants used for teens with depression. The drugs are thought to increase the risk of suicide in teens. To date, there are no FDA approved drugs for children under age 10 with bipolar disorder. Clinical trials are underway to determine the side effects of these bipolar drugs in both children and youth.

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