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Adasuve and Pregnancy

It is unknown if it is safe for pregnant women to use Adasuve (loxapine inhalation powder). Research has not been done to determine the possible risks of using this medicine in pregnant women. However, when the active ingredient in this powder was given to pregnant animals, it increased the risk for miscarriage and fetal kidney problems.

Can Pregnant Women Use Adasuve?

Adasuve™ (loxapine inhalation powder) is a prescription antipsychotic medicine used to control agitation in people with schizophrenia or bipolar disorder. This medication may not be safe for use during pregnancy.

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Adasuve is classified as a pregnancy Category C medicine.
Pregnancy Category C is given to medicines that have not been studied in pregnant women but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Adasuve itself has not been studied in pregnant women. However, the active ingredient of the drug, loxapine, has been studied in animals. In these studies, the drug increased the risk for problems, including miscarriages and fetal kidney problems, when given to pregnant rats. 
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine can be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
Antipsychotic medicines, such as Adasuve, have been associated with withdrawal symptoms and movement-related symptoms (called extrapyramidal symptoms) in newborns when used in the third trimester of pregnancy. Reported withdrawal and movement-related symptoms in newborns whose mothers used antipsychotics include:
  • Agitation
  • Increased or decreased muscle tone
  • Tremors
  • Sedation
  • Serious breathing problems
  • Feeding difficulty.
In some cases, the symptoms were mild and resolved on their own without treatment. In other cases, the symptoms were severe enough to require treatment, including extended hospital care or treatment in an intensive care unit.
Pregnancy and Pain

Adasuve Drug Information

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