Women who have a history of epilepsy are frequently prescribed the anti-seizure medicine Topamax or Depakote. In pregnant women, seizures are particularly dangerous, as they can restrict oxygen to the fetus. For years, these antiepileptic drugs have been deemed safe to prescribe to pregnant women. But the U.S. Food and Drug Administration (FDA) has recently raised some causes for concern with these drugs.
In the spring, the FDA decided to reclassify Topamax as a pregnancy Category D drug because it now has evidence that it can cause problems to the fetus. Research by the North American Antiepileptic Drug Pregnancy Registry showed that women who took the drug during the first trimester were four times more likely to have a child with an oral cleft. A cleft can deform the child’s mouth and affect eating, talking, their appearance, and can even cause more ear infections. Corrective surgery is required within the infant’s first year to prevent these complications from occurring.
Last year, the FDA reported that Depakote could have more serious side effects for children of mothers who used it during the first trimester. The most serious side effect was spina bifida, but urinary problems, holes in the heart, abnormal skull formation, malformed limbs, and cleft palates also occurred.
Motherisk, an information and counseling center for expectant mothers, reports that the risk of these complications is dose dependent. Risks from these antiepileptic drugs “begin increasing at doses of 600 mg/d and become more prominent at doses above 1000 mg/d.” More importantly, many expectant moms only discover they are pregnant after the first critical weeks of the first trimester, when damage to the fetus may have already occurred.
The FDA advises that pregnant women should consult their doctor immediately. For many women, the drug is necessary for her and the child’s safety. The FDA recommends that if a woman needs to stay on the antiepileptic medicine, the lowest dose possible for seizure control is best.
When healthcare professionals or drug manufacturers fail to adequately warn women about the dangers of taking these and other potentially dangerous drugs, they have a right to pursue legal action and monetary compensation for their child’s past, current, and future medical concerns.
In Illinois, Chicago birth injury lawyer Robert I. Briskman has decades of experience suing medical practices and product manufacturers who did not have the best interests of their patients at heart. As a Chicago birth injury attorney, he has handled many different types of birth injuries and will tirelessly work to get you the care that you and your baby deserve. The law firm of Briskman Briskman & Greenberg works on a contingency basis, so there is no payment unless they are successful in getting your child compensation.