Topamax (Topiramate) Birth Defect
Prior to March 7, 2011, Topamax was a "Pregnancy Category C" drug. A Category C drug is one known to be harmful to an animal fetus, but not to a human fetus. On March 7, 2011, the FDA issued a "Safety Announcement" informing the public and doctors that babies born to women who take Topamax during pregnancy are at an increased risk of developing birth defects such as a cleft lip and/or cleft palate, which are known as craniofacial defects, as well as hypospadius genital defects in boys. The same day, the FDA changed Topamax to a "Pregnancy Category D" drug. A Category D drug is one known to have positive evidence of human fetal risk, and should be used during pregnancy only when the alternatives are worse.
A cleft palate from Topamax is a birth defect where tissues of the hard or soft palate, also known as the roof of the mouth, do not form properly when the baby in is the womb. This extent of the defect can vary from mild to severe. In mild cases, there may only be a small hole in the back of the throat. In severe cases, the roof of the mouth may be almost non-existent, which can lead to visible facial deformities. Depending upon severity of the defect, children with a cleft palate may have trouble eating, drinking and breathing, and may experience sleep apnea and chronic ear infections. Surgical repair is often necessary.
A hypospadial defect is one where the male urinary opening is located on the bottom of the penis, rather than at the end. It can be corrected with surgery and is not frequently associated with sexual dysfunction.
Following the FDA release, Bottar Law, PLLC began investigating Topamax labeling, including whether pregnant women were sufficiently aware of the statistically significant risk of fetal harm due to consumption of Topamax during pregnancy. If Ortho-MacNeil Pharmaceutical knew or should have known of the risks and did not disclose all-together, or provided an inadequate warning to physicians and consumers on bottles and package inserts, it may be liable for damages, including compensation for:
- physical discomfort;
- physical disfigurement;
- loss of enjoyment of life; and
- surgical correction.