The Food and Drug Administration (FDA) has published a security alert that there has been an increased hereditary malformation of babies born to mothers who took Topamax during pregnancy. The study has shown a connection between Topamax to cleft lips and/or cleft palates (oral clefts) and other serious congenital malformations.

Children born with cleft lip and cleft palate has been observed of suffering from multiple complications associated with the birth defects, including feeding difficulties, chronic ear infections, hearing loss, missing or malformed teeth, and speech and language delay. However, these defects can be repaired by reconstructive surgery.

The government, after acknowledging the findings of the study, stated that Topamax will be placed in Pregnancy Category D, which indicates that there is a direct evidence of defect to the baby.

Topamax has been approved by the FDA to be used for the treatment of epilepsy and to prevent migraines, but it is often prescribed “off label” for various disease which includes Bi-directional disorder, cluster headaches, eating disorders, obesity, fibromyalgia, depression, post-traumatic stress disorder (PTSD), alcoholism, sleep disorders, eating disorders, infantile seizures, autism.