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