Primidone Pregnancy and Breast Feeding Warnings
Primidone is also known as: Mysoline
Overview
Primidone may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Primidone while you are pregnant. Primidone is found in breast milk. Do not breast-feed while taking Primidone .
Primidone Pregnancy Warnings
Primidone has not been assigned to a pregnancy category by the FDA. Animal studies on primidone have shown palatal clefting to be the most common defect and to be dose related. There are no controlled data in human pregnancy. An association has been suggested between the use of use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in the children born to these women. Because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life, the manufacturer has stated that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures. Alternatively, if the severity and frequency of the seizure disorders is felt to be such that removal of the drug is not believed to pose a serious threat to the patient, then discontinuation of the drug may be considered prior to and during pregnancy. The danger of the medication should be weighed against the possibility that even minor seizures may pose a hazard to the developing embryo or fetus.
Neonatal hemorrhage has been reported in newborns whose mothers were taking primidone and other and other anticonvulsants. Therefore, prophylactic administration of vitamin K1 therapy for one month prior to and during delivery is recommended for pregnant women on anticonvulsant therapy. Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.
Primidone Lactation Warnings
Primidone is excreted into human milk in substantial amounts. The manufacturer states that the presence of undue somnolence and drowsiness in nursing newborns of primidone treated mothers is as an indication that nursing should be discontinued.
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