Focalin

THE SAFETY OF DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:

There is limited evidence available on the safety of dexmethylphenidate during pregnancy. It is important to weigh the risks versus the benefits of taking this medication during pregnancy.

What is dexmethylphenidate?

Dexmethylphenidate is a stimulant medication. Dexmethylphenidate is related to the medication methylphenidate.

What is dexmethylphenidate used to treat?

Dexmethylphenidate is a controlled prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in children over 6 years of age and adults. ADHD is a brain disorder characterized by inattention (disorganization and difficulty focusing), impulsive behaviors (acting or speaking without thinking), and/or hyperactive behaviors (restlessness and constant movement). Without proper identification and treatment, many people with ADHD struggle academically, at work, or socially. You can read more about ADHD during pregnancy here.

How does dexmethylphenidate work?

Dexmethylphenidate stimulates the brain and spinal cord by decreasing the reuptake of the neurotransmitters dopamine and norepinephrine. 

If I am taking dexmethylphenidate, can it harm my baby?

It is possible that dexmethylphenidate could harn your baby, but the research is not clear.

There is limited information available on the safety of dexmethylphenidate in pregnancy. It is unknown if dexmethylphenidate crosses the  human placenta to reach the developing baby. Animal studies have identified an increased risk of delayed bone growth and low body weight in infants exposed to dexmethylphenidate. Some case reports show that maternal dexmethylphenidate exposure during pregnancy may contribute to prematurity, poor growth, and symptoms of withdrawal in the baby. There have been a few case reports of heart defects linked to in utero dexmethylphenidate exposure, but studies remain mixed and have failed to prove a direct link between dexmethylphenidate use during pregnancy and heart defects. A Danish study found no associated risk between use of a related medication, methylphenidate, during the first trimester and major birth defects in newborns. A recent study suggests methylphenidate use during the first trimester may be associated with a small increase in risk of heart defects, but further study is required. One study found that stimulants such as methylphenidate may be associated with development of preeclampsia in the mother. Methylphenidate was identified as a predictor for miscarriage in another study.

If I am taking dexmethylphenidate and become pregnant, what should I do?

Women who are attempting to conceive or become pregnant while on dexmethylphenidate should speak with their doctor. It is important to weigh the risks and benefits of continuing dexmethylphenidate therapy during pregnancy. It is recommended that you avoid dexmethylphenidate use during pregnancy. Women continuing this medication during pregnancy should take the lowest effective dose and avoid first trimester use. Dexmethylphenidate has not been associated with major birth defects, but use during pregnancy is linked to poor growth of the developing baby, prematurity, and symptoms of dexmethylphenidate withdrawal after birth. 

If I am taking dexmethylphenidate, can I safely breastfeed my baby?

Dexmethylphenidate is expected to pass into breast milk. It is estimated that infants are exposed to less than 0.7% of the mother’s dose. In women requiring dexmethylphenidate therapy while breastfeeding, dexmethylphenidate can be continued. It is important to consider the risks to the infant and benefits to the mother before continuing this medication during breastfeeding. Infants who are exposed to dexmethylphenidate through breast milk should be monitored for adverse events such as stomach pain, poor weight gain, fever, and upset stomach. High levels of dexmethylphenidate for long periods of time may decrease milk production in women who are nursing infants.

If I am taking dexmethylphenidate, will it be more difficult to get pregnant?

It should not be harder to get pregnant while using this medication. Dexmethylphenidate has not been associated with negative effects on fertility in animal studies.

If I am taking dexmethylphenidate, what should I know?

There is limited information available on the safety of this medication during pregnancy. Dexmethylphenidate should only be used during pregnancy if the benefits to the mother outweigh the risks to the developing baby. There may be an increased risk of low birth weight and preterm delivery associated with this medication. Mothers who continue breastfeeding while on dexmethylphenidate should monitor their baby for adverse effects.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of dexmethylphenidate extended-release during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about ADHD here,  and reports about the individual medications used to treat mental health conditions here.   Additional information can also be found in the resources below. 

For more information about dexmethylphenidate during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Novartis: Focalin Prescribing Information

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.