Primidone Pregnancy and Breastfeeding Warnings

Primidone is also known as: Mysoline

Primidone Pregnancy Warnings

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. To provide information regarding the effects of in utero exposure to primidone, physicians are advised to recommend that pregnant patients taking primidone 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/.

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.

Primidone Breastfeeding 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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