Abilify Maintena and Pregnancy

It is unknown whether it is safe for women to use Abilify Maintena (aripiprazole ER injection) when pregnant. This pregnancy Category C medicine was shown to cause miscarriages, skeletal defects, and slow development in animal studies. However, the drug has not been studied in humans. Talk to your healthcare provider about whether the benefits outweigh the potential risks in your particular situation.

Can Pregnant Women Use Abilify Maintena?

Abilify Maintena™ (aripiprazole ER injection) is an injectable prescription medication approved to treat schizophrenia. It is in a class of medications known as antipsychotics. 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. Abilify Maintena is classified as a pregnancy Category C medicine.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans 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.
When given to pregnant animals, Abilify Maintena caused various problems, such as low birth weight, slow development, undescended testicles, miscarriages, and skeletal defects. Also, the female offspring were less fertile than normal.  
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 may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Abilify Maintena has not been studied in pregnant women. However, when used in the third trimester (the last three months of pregnancy), antipsychotic medicines may increase the risk for withdrawal symptoms and movement-related symptoms (called extrapyramidal symptoms) in newborns. This is based on reports of symptoms in newborns whose mothers took antipsychotics. Reported symptoms have included:
  • Agitation
  • Increased or decreased muscle tone
  • Tremors
  • Sedation
  • Serious breathing problems
  • Difficulty feeding.
In some cases, the symptoms resolved on their own. However, in other cases, the newborns required treatment, including prolonged hospitalization or care in an intensive care unit.
Your healthcare provider may still recommend treatment with Abilify Maintena despite these potential risks. This is because untreated schizophrenia may also be harmful to a pregnant woman and her unborn baby. Therefore, it is important that you not stop treatment without first talking to your healthcare provider. Stopping treatment may cause your symptoms to return.
Pregnancy and Pain

Abilify Maintena Medication Information

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