Ritalin LA

THE SAFETY OF LONG-ACTING METHYLPHENIDATE (RITALIN LA) 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 MAY CAUSE HARM TO YOUR BABY:
There is limited evidence available on the safety of long-acting methylphenidate during pregnancy. It is important to weigh the pros and cons of taking this medication during pregnancy.

What is methylphenidate?

Methylphenidate is a stimulant medication. Long-acting methylphenidate is a form of methylphenidate that releases some of the drug immediately, followed by another release of the drug later in the day.

What is methylphenidate used to treat?

Methylphenidate is a controlled prescription medication used to treat attention deficit hyperactivity disorder (ADHD).

How does methylphenidate work?

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

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

There is limited information available on the safety of methylphenidate in pregnancy. Studies show that stimulant medications such as methylphenidate can decrease blood flow to the placenta, causing low birth weight and premature delivery. A Danish study found no associated risk between methylphenidate exposure during the first trimester and major birth defects in newborns. One study found that stimulants such as methylphenidate may be associated with development of preeclampsia. Methylphenidate was associated with miscarriage in another study. In pregnant women with ADHD, methylphenidate is considered a treatment option.

Evidence:

A recent study looked at 1,813,894 pregnancies in the United States and 2,560,069 pregnancies in the Nordic Health registries. The study compared women who were taking methylphenidate or amphetamines (another ADHD medication) during the first trimester of pregnancy to women who were not. The study found that moms who took methylphenidate had an overall increased rate of birth defects and a higher rate of birth defects in the baby’s heart. After adjusting for various factors (such as demographics and other psychiatric illnesses the moms may have had), the use of methylphenidate during pregnancy was still linked to a significantly higher rate of birth defects in the heart. 

Another recent study from the Centers for Disease Control (CDC) analyzed 64 expecting moms who took any ADHD medication during pregnancy. Women who took an ADHD medication early in pregnancy were more likely to have babies born with limb defects and two types of birth defects where the baby’s intestines and/or other organs are found outside the body (gastroschisis and omphalocele). It is important to note that this study did not separate the results based on the specific ADHD medication that the expecting moms took. Therefore, some moms may have taken ADHD medications other than methylphenidate (the main ingredient in Ritalin LA). Of the 64 expecting moms who were studied, 37.8% took a medication containing methylphenidate. 

A study analyzed 38 expecting moms who used methylphenidate in combination with a medication used to control pain. They found that the use of these medications was associated with premature birth, growth restriction (babies born smaller than normal for their age), and signs of withdrawal in the baby. Four of the babies had birth defects but the study did not link methylphenidate use to a higher risk of birth defects. Several of the moms in the study were also using alcohol, drugs, and cigarettes, which may have caused birth defects or health problems in the babies.

Bottom Line: Methylphenidate should not be used during pregnancy unless medically necessary and the benefits to the mom outweigh potential risks to the baby. Taking methylphenidate during pregnancy has been linked to a higher risk of birth defects in the heart.

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

Women who are attempting to conceive or become pregnant while on methylphenidate should speak with their doctor. It is important to weigh the risks and benefits of continuing methylphenidate therapy during pregnancy. Caution is advised when continuing methylphenidate therapy during pregnancy. Methylphenidate 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 methylphenidate withdrawal. 

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

Methylphenidate is expected to pass into breast milk. It is estimated that infants are exposed to less than 0.7% of the mother’s dose. It is important to consider the risks to the infant of continuing methylphenidate during breastfeeding compared to the benefits of continuing the medication for the mother. Methylphenidate should only be taken by women who are nursing if they would benefit from therapy without causing harm to their nursing infant. Infants who are exposed to methylphenidate through breast milk should be monitored for adverse events such as irritability, poor weight gain, and disruptions in sleep. High levels of methylphenidate for long periods of time may decrease milk production in women who are nursing infants.

Bottom Line: Methylphenidate should be used while breastfeeding only if the benefits to the mom outweigh potential risks to the baby. Your doctor will determine if the medication is medically necessary and should be continued while nursing. This medication passes into breast milk and could cause side effects in your baby. If you are taking methylphenidate while breastfeeding, contact your doctor if you notice that your baby is experiencing any side effects, including agitation, decreased appetite, and reduced weight gain.

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

Methylphenidate changes the amounts of certain chemicals in your brain. The effects of these chemicals can influence your reproductive hormones, which may affect fertility. Animal studies have shown that methylphenidate may impair fertility in both males and females, but human studies are needed to confirm this finding. A study in young boys found that short-term use of methylphenidate did not affect salivary testosterone levels, but it is unknown if long-term use of methylphenidate would affect testosterone levels.

If I am taking methylphenidate, what should I know?

Methylphenidate 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 methylphenidate 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 long-acting methylphenidate 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 methylphenidate during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Novartis:  Ritalin LA Prescribing Information

U.S. National Library of Medicine: Methylphenidate

National Institutes of Mental Health: Attention Deficit Hyperactivity Disorder

Read the whole report
Last Updated: 13-06-2019
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.