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Lamotrigine Pregnancy and Breastfeeding Warnings

Lamotrigine is also known as: Lamictal, Lamictal CD, Lamictal ODT, Lamictal XR

Lamotrigine Pregnancy Warnings

-Antiepileptic drugs are associated with an increased risk of teratogenicity (the risk is decreased with monotherapy). However, epilepsy itself may be associated with an increased risk of congenital malformations. It is recommended that pregnant women and women who are planning to become pregnant should be referred to a specialist and apprised of the potential hazards to the fetus. Folic acid 5 mg daily should be taken before conception and during pregnancy; -Pregnancy increases clearance of this drug by over 50%. This effect occurs early in pregnancy and reverts quickly after delivery. Drug levels should be monitored before, during, and after pregnancy. -Women should be advised to notify their doctor if they plan to start or stop use of oral contraceptives or other female hormonal preparations. Physicians are advised to recommend that pregnant patients taking lamotrigine enroll in the 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 http://www.aedpregnancyregistry.org/. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless clearly needed. AU TGA pregnancy category: D US FDA pregnancy category: C for immediate release and D for extended release Comments: -Antiepileptic drugs are associated with an increased risk of teratogenicity (the risk is decreased with monotherapy). However, epilepsy itself may be associated with an increased risk of congenital malformations.

Lamotrigine Breastfeeding Warnings

This drug should not be used unless there are no safer alternatives. Excreted into human milk: Yes Comments: -Data from studies indicate that plasma levels of this drug in human milk-fed infants have been reported to average 30% to 35% (sometimes up to 50%) of the maternal serum levels.

-Exposure is further increased due to the immaturity of the infant glucuronidation capacity needed for drug clearance. Side effects including apnea, drowsiness, and poor sucking have been reported in infants who have been human milk-fed by mothers using this drug; whether or not these events were caused by the drug is unknown. Human milk-fed infants should be closely monitored for adverse events. Human milk-feeding should be discontinued in infants with toxicity to this drug.

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