Topamax Birth Defects

Initially prescribed for epilepsy, and also used in the treatment of migraines, alcoholism and obesity, Topamax, or Topiramate, has more recently been blamed for the noticeable increase in Topamax birth defects including oral deformities found in newborn babies.

Who is at Risk for Topamax Birth Defects?

According to the FDA report released in March of 2011, women who took Topamax during the first trimester of their pregnancy were at greater risk of having a child born with a noticeable Topamax birth defects such as an oral deformity leading to long term potential complications. Based on information from the North American Antiepileptic Drug Pregnancy Registry (AED), 1.4% of the infants subjected to Topamax during the first trimester developed oral deformities from the exposure.

Those children subjected to anticonvulsant drugs other than Topamax were at a risk level of 0.38-0.55%, while those infants exposed to no antiepileptic medications at all fared best at only 0.07%. Since these Topamax birth defects progress during the early stages of pregnancy, the FDA reports that they are only present at birth and cannot develop at a later time. However, the FDA report also states that Topamax can be passed to an unaffected infant through breastfeeding and advises mothers to consult their doctors as to this safety issue.

What are Topamax Birth Defects?

Topamax birth defects include cleft lips and cleft palates which are disorders suffered by infants exposed to Topamax in the first trimester of fetal development. During this stage, Topamax exposure can interrupt normal oral development causing a partition of the lips. This is known as cleft lip syndrome. A cleft palate occurs when Topamax, again, causes an interruption in the physical development of the roof of the mouth and lips. In more serious cases, Topamax birth defects can include partitions which can affect the infant’s lips, palate and nose.

If left untreated, these Topamax birth defects can result in ear infections, problems eating and speech development. These serious Topamax birth defects can only be repaired by surgery, and most physicians recommend corrective oral surgery soon after birth.

Did the FDA Know About Topamax Birth Defects?

At the time Topamax was approved, the FDA had only animal trials by which to measure risk. These findings showed potential fetal risks in animal births but since no human trials existed at that time, Topamax was issued a category “C” rating. Because of the increased risk of Topamax birth defects, Topamax is now being classified as a category “D” drug, meaning a risk to human fetal development is present.