FDA Warns of Oral Birth Defect Risks in Children of Mothers Taking Topamax
The Food and Drug Administration (FDA) has provided data that suggests risks of the birth defects cleft lip and cleft palate in infants born to women who use the drug Topamax (topiramate) during pregnancy. According to the FDA news release, the North American Antiepileptic Drug (AED) Pregnancy Registry determined that infant Topamax exposure during the first trimester of pregnancy increases the risk of Topamax cleft palate. It is vital for a patient to continue use of Topamax until they speak with their doctor. A person who suddenly stops taking Topamax can suffer serious health problems.
Topiramate is prescribed to treat specific kinds of seizures in individuals with epilepsy. Health care professionals have the important responsibility of warning patients of childbearing age about the possible dangers to the fetus if a woman becomes pregnant while taking Topamax. The drug is also used to prevent migraine headaches.
Data revealed that infants of mothers who took Topamax experienced a 1.4 percent incidence of oral clefts, as opposed to an incidence of 0.38 percent – 0.55 percent for infants whose mothers took other antiepileptic medications. Mothers who did not have epilepsy and were not taking any antiepileptic pharmaceuticals gave birth to infants with a 0.07 percent incidence of the birth defect.
Is topamax on the unsafe drug list?
With the discovery of this new data comes a stronger Topamax label warning and the addition of a Pregnancy Category D. This indicates evidence of human fetal risk based on recorded human data, but also suggests that the possible benefits of Topamax could outweigh the dangers in some cases.
Oral clefts of the lip or palate are birth defects that take place when portions of the lip or palate do not fully connect together during the first trimester of a woman’s pregnancy. The risks of Topamax birth defects are all the more dangerous since the first trimester is often a time when many women are not aware of their pregnancy. Cleft palate causes problems with eating and talking in addition to resulting in ear infections. The birth defects can cause a small notch in the lip or a groove along the roof of the mouth and nose.
It is unimaginable what parents whose child has suffered a cleft palate due to Topamax must cope with, not to mention the pain and suffering of the child. A Topamax birth defect lawyer can help you understand your legal rights and options so that negligent parties are held responsible.
Michael Monheit is the managing lawyer at Monheit Law, outside Philadelphia, Pennsylvania. He has practiced law since 1989. Michael Monheit was the managing attorney of the law offices of Herbert Monheit — now Silverman and Fodera — a firm... Michael Monheit→