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A pregnant female looking downward: Is it safe to take Vraylar while pregnant?
Drug Info

Vraylar and pregnancy: Important safety considerations

Weighing the pros and cons of taking Vraylar during pregnancy
Sarah Bradley writer headshot
By | Jul. 8, 2024 Medically reviewed by Jessica Swirble, Pharm.D.

Key takeaways

  • Vraylar is an atypical antipsychotic medication that is still considered relatively new, which means there isn’t a lot of information available about its safety during pregnancy or breastfeeding.

  • Some animal studies have shown the potential for risk to the developing fetus, but there’s a lack of human studies to determine Vraylar’s safety. Human studies have shown a higher risk of withdrawal symptoms in newborns whose mothers took Vraylar during pregnancy.

  • Experts often compare the use of Vraylar to that of Abilify, which is a pregnancy category C drug, along with many Vraylar alternatives, like Haldol and Risperdal.

  • It is important to talk to your healthcare provider about how best to treat your illness during pregnancy and which medications are safest for managing your symptoms.

In this article:

People with certain mood disorders, such as schizophrenia and bipolar disorder, may be prescribed a drug called Vraylar (cariprazine) to help manage their symptoms. It’s an atypical antipsychotic medication that affects both dopamine and serotonin receptors, says Alyssa Dweck, MD, OB-GYN and women’s health expert for INTIMINA. 

It’s also relatively new: Vraylar came on the market in 2015, and the Food and Drug Administration (FDA) has been slowly approving it for different uses since then, including a 2022 approval for use alongside antidepressants in people with major depressive disorder. However, because Vraylar is a newer treatment, it hasn’t been well-studied in every population, including pregnant women. 

It is very important to have a talk with your healthcare provider about any medications you’re taking as soon as possible once pregnant. Unless the benefit clearly outweighs the risk, your provider may recommend that you not take Vraylar during pregnancy. Here’s what to know about Vraylar and pregnancy, including what you can more safely take instead of Vraylar to treat your mood disorder while pregnant.

Can you take Vraylar while pregnant?

The FDA classifies drugs used during pregnancy into one of five categories—A, B, C, D, and X—with A being the safest and X being unsafe. “The use of Vraylar during pregnancy hasn’t been studied, so its safety is unknown, and the FDA has not assigned Vraylar any type of pregnancy safety category,” Dr. Dweck says. For that reason, many providers don’t recommend using it during pregnancy.  

Vraylar has a half-life (the length of time it will take for half of a dose to be eliminated from the body) of seven days, according to its manufacturer, AbbVie. However, Vraylar has metabolites that have longer half-lives than cariprazine (the active ingredient in Vraylar) alone. After regular use, Vraylar can be detected in the body for up to 12 weeks after stopping the drug. This is important to remember if there are chances of becoming pregnant while taking Vraylar or soon after discontinuing your use, according to Dr. Dweck.

What are the risks of taking Vraylar while pregnant?

“All antipsychotics cross the placenta during pregnancy in a way that may have negative side effects on a developing baby,” Dr. Dweck says. But because Vraylar is a newer drug, experts aren’t sure yet what those side effects are or how likely they are to occur.

Alex Dimitriu, MD, psychiatrist, sleep medicine specialist, and founder of Menlo Park Psychiatry & Sleep Medicine in California, says many experts compare the use of Vraylar during pregnancy to that of Abilify (aripiprazole). The two drugs are closely related, he adds, but Abilify has been around longer and studied far more than Vraylar.

“In the medical literature, aripiprazole is pregnancy category C, meaning it has been shown to have adverse effects in animals and uncertain effects in humans,” Dr. Dimitriu says. 

A drug is labeled as pregnancy category C when animal studies have shown a risk to the fetus, and there are no reliable studies in humans (but the potential benefits of the drug may outweigh the risks). 

This tracks with what researchers have seen in their preliminary studies of Vraylar. The Vraylar drug label states that the drug was associated with fetal malformations, lower survival rates, and developmental delays when given to pregnant rats (although not when given to pregnant rabbits, even at higher doses). 

That leaves providers with mixed results to rely on when assessing the risk for humans, especially since human studies are limited—and the research we do have shows evidence of potential risk to humans: “Withdrawal symptoms have been reported in neonates whose mothers were exposed to antipsychotic drugs during the third trimester,” Dr. Dweck says.

RELATED: Vraylar withdrawal: What to expect when stopping the drug

The FDA has also made it clear that all antipsychotic drugs have the potential to cause abnormal muscle movements and withdrawal symptoms (like agitation, tremors, sleepiness, and difficulty with feeding) in newborn babies exposed to these drugs through their mothers during pregnancy.  

Can you take Vraylar while breastfeeding?

The prescribing information for Vraylar notes that the drug has been found in the milk of lactating rats, but no studies have been done to confirm whether it passes into the breast milk of humans (and what effects it could have on a breastfeeding baby if it did).

Dr. Dweck says Abilify has been shown to pass through breast milk in small quantities with no adverse effects on the newborn, but there’s no clear information about Vraylar’s effects on babies breastfeeding from mothers taking the drug. 

What can you take instead of Vraylar during pregnancy?

In general, there are several medications that can be taken instead of Vraylar, but many of these alternatives are also antipsychotic drugs and could pose the same potential risk to pregnancy. As Dr. Dimitriu points out, though, we have more information about the use of some of these drugs during pregnancy because they have been around longer; in that way, it may be safer to take one of the alternatives simply because it’s not a newer and less-studied drug like Vraylar.

Dr. Dweck points to the American College of Obstetrics and Gynecology (ACOG), which published a set of guidelines regarding the use of psychiatric medications during pregnancy. In the antipsychotic category, only clozapine is a pregnancy category B drug, which means no risk to the fetus has been found in animal studies. All of the other antipsychotic drugs, such as Abilify (aripiprazole), haloperidol, Risperdal (risperidone), and Zyprexa (olanzapine), are pregnancy category C drugs.

However, a lower pregnancy category rating doesn’t mean it’s always safer to stop taking Vraylar or another antipsychotic drug during pregnancy. In its guidelines, the ACOG cautions against automatically recommending that women with psychiatric illnesses stop taking any medications because this can also be harmful to both the mother and the baby.

“The risks versus benefits of taking such a medication need to be closely considered,” Dr. Dimitriu says. “There is significant data supporting the need to continue treatment of mental health conditions during pregnancy if possible, because the mental state of the mother may have even more significant effects on the well-being of the baby.”

Bottom line

If you’re already taking Vraylar and become pregnant, it may not be necessary to discontinue the use of the drug, as long as it’s successfully treating your symptoms and helping you manage your illness. However, there’s a lot we don’t know about the use of Vraylar during pregnancy. Women who need to start taking any antipsychotic during pregnancy should have a conversation with their healthcare provider about what their options are, such as drugs that have more safety information available. But ultimately, these are decisions that each woman needs to make with the help of a knowledgeable healthcare provider.