THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Aptensio XR should not be used during pregnancy unless medically necessary and the benefits to the mother outweigh potential risks to the baby. Taking methylphenidate during pregnancy may increase the risk that your baby will have birth defects in the heart.
What is Aptensio XR?
Aptensio XR capsules contain methylphenidate, which is a central nervous system stimulant. Central nervous system stimulants make you feel more awake and increase energy, attention, and alertness. Aptensio XR is an extended-release formulation, meaning that the effects of the medication last longer. Aptensio XR only needs to be taken once daily; it should be taken in the morning and consistently either with or without food. This medication should not be taken in the late afternoon or evening because it can keep you awake through the night. Aptensio XR is a controlled medication in the U.S., meaning that the government regulates its use. It is only available by prescription from your doctor.
What is Aptensio XR used to treat?
Aptensio XR is used to treat attention-deficit hyperactivity disorder (ADHD) in adults and children over the age of 6. 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 socially, academically, or at work. You can read more about ADHD during pregnancy here.
How does Aptensio XR work?
Aptensio XR affects certain chemicals in your brain to promote wakefulness and alertness. It is unknown how the actions of these chemicals improve the symptoms of ADHD. Aptensio XR helps people with ADHD focus on tasks, maintain attention, control behavioral problems, and improve listening skills. Central nervous system stimulants such as Aptensio XR speed up your mental processing, but they also speed up processes throughout the rest of your body. This can cause side effects such as faster heart rate, higher blood pressure, and reduced appetite. Stimulants can also cause anxiety, nervousness, and sleeping difficulties. They can be dangerous unless used under the guidance of your doctor.
If I am taking Aptensio XR, can it harm my baby?
Aptensio XR (methylphenidate) should not be used unless medically necessary and the benefits of treatment to the expecting mom justify the potential risks to the 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 association between methylphenidate exposure during the first trimester and major birth defects in newborns. There have been a few case reports of heart defects linked to in utero methylphenidate exposure, but studies remain mixed and have failed to prove a direct link between methylphenidate use during pregnancy and heart defects. 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. Methylphenidate was identified as a predictor for miscarriage in another study. For some expecting moms, discontinuing ADHD medications can impair functioning at school or work and increase the risk of motor vehicle accidents. In these cases, your doctor may decide that Aptensio XR is medically necessary.
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 Aptensio XR). 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: Aptensio XR 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 Aptensio XR and become pregnant, what should I do?
If you become pregnant while taking Aptensio XR, you should contact your doctor immediately. Your doctor may decide to discontinue your medication until after the birth of your baby.
If I am taking Aptensio XR can I safely breastfeed my baby?
Caution should be used if moms take Aptensio XR while breastfeeding because the effects of this medication on breastfed infants are unknown. Your doctor will determine if Aptensio XR is medically necessary while breastfeeding and whether breastfeeding should be continued. Methylphenidate passes into breast milk in small amounts. Since methylphenidate is a central nervous system stimulant, it could cause harmful effects to your baby. Moms who take Aptensio XR while breastfeeding should monitor their baby for side effects including irritability, agitation, reduced weight gain, lower appetite, and sleeping difficulties. If you notice any of these symptoms in your baby, contact your doctor immediately. It may indicate that your baby is experiencing side effects from your medication. There is very little data on the safety of methylphenidate while breastfeeding and the data that is available only consists of a few case reports. No side effects were observed in three breastfed babies whose moms used methylphenidate while breastfeeding. However, the long-term effects of methylphenidate on brain development in breastfed babies are unknown.
Bottom Line: Caution should be used if taking Aptensio XR while breastfeeding. 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 Aptensio XR while breastfeeding, contact your doctor if you notice that your baby is experiencing any side effects, inclu
ding agitation, decreased appetite, and reduced weight gain.
If I am taking Aptensio XR, will it be more difficult to get pregnant?
There have been no studies looking at the effects of Aptensio XR on fertility in men or women. However, 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 Aptensio XR, what should I know?
Aptensio XR should not be used during pregnancy unless medically necessary and the benefits to the mom justify the potential risks to the baby. Taking methylphenidate during pregnancy has been shown to increase the risk of birth defects in the heart.
Caution should be used if Aptensio XR is used while breastfeeding. Methylphenidate passes into breast milk and may cause side effects in the breastfed baby. If you are taking Aptensio XR while breastfeeding, contact your doctor if you notice that your baby has a reduced appetite, is more irritable, or is having sleeping difficulties. These symptoms could be the result of your medication.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of Aptensio XR 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 Aptensio XR during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
National Institutes of Mental Health: Attention Deficit Hyperactivity Disorder
WebMD: Aptensio XR