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  • Lamotrigine nursing toddler

    Hi, I was recently diagnosed with a brain cyst that is causing seizures. I was prescribed lamotrigine and having been slowly tapering up from 50mg (25mg/2x day) to 100mg (50mg/ 2x day). My neurologist is willing to let me stay at the lowest dose possible that controls my episodes, knowing that I am still nursing my 13 month old. This doctor also researched the drug and said it seems like one of the safest anticonvulsants to take during nursing, although he suggested long term cognitive effects on the child are not known. Can you inform me about any potential long-term negative effects on my son if I continue to nurse him and take the med? I had planned to let him self-wean, is this advisable, can I keep nursing my toddler safely while on this drug, or should I start the weaning process?
    Last question-are there any special/ specific risks of starting this drug and nursing a toddler who has never been exposed to it? I know a lot of women on the drug take it through pregnancy, so children who are nursed have already been exposed in utero.
    Thank you in advance for your time and expertise.

  • #2
    I'm sorry I posted this in 3 different forums...wasn't sure where to place it and really want some feedback.

    Comment


    • #3
      Dcarlo:


      Lamotrigine is a newer anticonvulsant primarily indicated for treatment of simple and complex partial seizures. High relative infant dose and significantly high infant plasma levels (range 20-43% of maternal levels) suggests significant transfer to the infant. Infants should be closely monitored with occasional plasma levels. One case of severe apnea has been recently reported in a 16 day old breastfed infant. In this case, the mother was receiving 850 mg/day, had a plasma level of 14.93 µg/mL. The plasma level of the infant was 4.87 µg/mL. The use of lamotrigine in breastfeeding mothers produces significant plasma levels in some breastfed infants, although they are apparently not high enough to produce side effects in most cases. Exposure in utero is considerably higher, and levels will probably drop in newborn breastfed infants who are breastfed. Nevertheless, it is advisable to monitor the infant's plasma levels closely to ensure safety.

      About 9.2% - 18.2% of the clinical dose of lamotrigine is present in milk. At you dose of 100 mg/day, I wouldn't expect any complications particularly in a 13 month old infant.

      Tom Hale Ph.D.
      ]

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      • #4
        Dr. Hale, Thank you for your response. I know that SJS is a very rare reaction to this drug, and I have been on it now for 5 weeks with no rashes. Is this a concern for my breastfed toddler? Or would that type of reaction be limited to the mother taking it?

        Comment


        • #5
          Dcarlo:

          Its extremely rare but possible. The rate quoted is 0.3% to 0.8% in pediatric patients (2 to 17 years of age) in infants and children receiving clinical doses. Most often occurs with rapid dose increase, etc. I really doubt that the dose in milk would ever cause a SJ syndrome, but just be cautious of unusual rashes.

          Tom Hale Ph.D.

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          • #6
            Hi,

            I am not pregnant right now, but trying to plan ahead. My last seizure happened in 2013 and at that time, I was taking Keppra and Vimpat. I am currently only taking Vimpat (200 mg). Since there is not much data on Vimpat during pregnancy/breastfeeding, my neurologist gave me an option to start taking Lamotrigine since there is a lot more data on it and it seems like it might be less risky. Do you know what the risks are when using Vimpat compared to using Lamotrigine during pregnancy/breastfeeding?

            Thank you for providing us with a forum for our questions/concerns. Appreciate your thoughts.

            Comment


            • #7
              JustWondering,

              Vimpat during pregnancy is rated an P3-unknown-risk to fetus cannot be ruled out. "There are no adequate and well-controlled studies in pregnant women. Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. These effects were observed at doses associated with clinically relevant plasma exposures. Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential adverse effects on CNS development can not be ruled out. There are no adequate and well-controlled studies in pregnant women. VIMPAT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any teratogenic effects. However, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. These doses were associated with maternal plasma lacosamide exposures [area under the plasma-time concentration curve; (AUC)] ?2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (MRHD) of 400 mg/day. When lacosamide (25, 70, or 200 mg/kg/day) was orally administered to rats throughout gestation, parturition, and lactation, increased perinatal mortality and decreased body weights were observed in the offspring at the highest dose. The no-effect dose for pre- and post-natal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide AUC approximately equal to that in humans at the MRHD. Oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of postnatal development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). The early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide AUC approximately 0.5 times that in humans at the MRHD." (Medications and Mothers' Milk database, Dr Thomas Hale PhD).

              Vimpat in lactation is a L3-no data. "Due to its structure, levels in milk may be significant. No data are available on its transfer into human milk, but caution is recommended until we have more data." (Medications and Mothers' Milk database, Dr Thomas Hale PhD). Monitor the infant for sedation or irritability, not waking to feed/poor feeding, weight gain, vomiting, diarrhea, tremor.

              Lamotrigine is rated P3 in pregnancy-unknown-risk to fetus cannot be ruled out. "Lamotrigine does not appear to cause major congenital anomalies and is relatively safer than other seizure medications such as valproic acid. Prevention of seizures during pregnancy is important for the safety of the mother and fetus. Changing seizure medications during pregnancy is not advised due to the risk of increased seizure activity.[8] Folic acid supplementation is recommended prior to and during pregnancy when taking lamotrigine.[12] Lamotrigine should only be used during pregnancy if the benefit to the mother outweighs the risk to the fetus. Lamotrigine is an anti-seizure medication that is also used to treat bipolar disorder and epilepsy. The drug can cause serious rashes in patients including Stevens-Johnson disorder.[1] Lamotrigine does not appear to cause major congenital anomalies, but one drug registry found a slightly increased risk of cleft lip and palate.[2] Several studies have shown no increased risk of congenital malformations.[3-8] Drug levels must be monitored closely with lamotrigine as pregnancy alters how the drug is metabolized within the body, and drug levels may fall with subsequent development of breakthrough seizures. The drug level should then be decreased after delivery to prevent maternal toxicity.[9, 10] Oral contraceptives can decrease the blood levels of lamotrigine, thereby increasing the risk of break through seizures.[11] Pregnancy Exposure Registry: To provide information regarding the effects of in utero exposure to lamotrigine, physicians are advised to recommend that pregnant patients taking lamotrigine enroll in North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website [url]http://www.aedpregnancyregistry.org/[/url]. Physicians are also encouraged to register patients in the Lamotrigine Pregnancy Registry; enrollment in this registry must be done prior to any prenatal diagnostic tests and before fetal outcome is known. Physicians can obtain information by calling the Lamotrigine Pregnancy Registry at 1-800-336-2176 (toll-free). Labor and Delivery The effect of lamotrigine on labor and delivery in humans is unknown." (Medications and Mothers' Milk database, Dr Thomas Hale PhD).

              Lamotrigine in lactation is rated an L2-limited data-probably compatible. The amount that transfers into breast milk is 9.2-18.27% of your dose. "Infants should be closely monitored with occasional plasma levels. One case of severe apnea has been recently reported in a 16 day old breastfed infant. In this case, the mother was receiving 850 mg/day, had a plasma level of 14.93 µg/mL. The plasma level of the infant was 4.87 µg/mL. The use of lamotrigine in breastfeeding mothers produces significant plasma levels in some breastfed infants, although they are apparently not high enough to produce side effects in most cases. Exposure in utero is considerably higher, and levels will probably drop in newborn breastfed infants who are breastfed."(Medications and Mothers' Milk database, Dr Thomas Hale PhD). We do recommend monitoring the infants plasma levels 2-3 weeks postpartum, and periodically. Monitor the infant for sedation or irritability, not waking to feed/poor feeding, weight gain and rash. Based on clinical symptoms some infants may require monitoring of liver enzymes or CBC.


              Sandra Lovato R.N.
              InfantRisk Center
              806-352-2519

              Comment


              • #8
                Two questions that I was wondering about-my sezuires happened for no appaeent reason-how likely is that usually?

                Also, if a parent has epilepsy, what are the chances that the child will also have epilepsy? Thank you for your time.

                Comment


                • #9
                  JustWondering,

                  These are questions you would need to discuss with your Dr.

                  Sandra Lovato

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