The U.S. Food and Drug Administration (FDA) has urged all healthcare professionals to weigh first all the benefits and risks involved in Topamax medication before prescribing the antiepileptic drug to all women of childbearing age in view of all the serious side effects linked to it. According to several studies, infants exposed to the medication while inside their mothers wombs are at high risk of birth defects. Also, the
FDA has approved a new epilepsy drug which possibly has fewer side effects than Topamax.
Mothers who take Topamax during their pregnancy may have their babies born with cleft lip, cleft palate or hypospadias, according to studies whose reports are upheld by the FDA. Approved for the treatment of epileptic seizures in 1996 and for the prevention of migraine headaches in 2004, Topamax is manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson. It could either be prescribed as a monotherapy or as an adjunctive therapy. Topamax became the most prescribed drug for both conditions and was Johnson & Johnsons no.1 anticonvulsant.
Positive human evidence that Topamax would cause birth defects had the FDA elevating the antiepileptic drug from pregnancy category C to D after studies linked it to possible fetal malformations. Aside from its possible devastating effects to infants, other side effects noted when Topamax is prescribed as a monotherapy are paresthesia, weight decrease, somnolence, anorexia, dizziness, upper respiratory tract infection, diarrhea, and mood problems. When used as an adjunctive therapy, noted side effects are somnolence, dizziness, ataxia, speech disorders and related speech problems, psychomotor slowing, abnormal vision, difficulty with memory, paresthesia, diplopia, fatigue, nervousness, difficulty with concentration or attention, confusion, depression, anorexia, language problems, anxiety, mood problems, weight decrease, and aggressive reaction.
However, fetal malformations have been the most serious Topamax side effects so far and this prompted the FDA to suggest that alternative medications associated with a lower risk of birth defects be considered for all women of childbearing age. Should Topamax be a must treatment for women, the federal agency suggests the use of effective birth control.
