In normal fetal development, we normally start out life with a cleft lip and palate. Between the 6th and 11th week of pregnancy, the clefts fuse together. A “cleft” means separation while the “palate” is the inner top surface of the mouth. Cleft lip is the failure of the upper lips to normally fuse. This is commonly referred to as harelip. Cleft palate on the other hand is an opening of the palate. Both birth defects are also known as craniofacial anomalies. These anomalies can lead to serious complications such as hearing loss, recurrent ear infections, lip deformities and speech difficulties.
What are the Causes of Clefts?
There are no known definite causes but studies have shown that some factors such as genetics, genetic syndromes and the environment (poor pregnancy health, exposure to toxins, teratogens and certain drugs) contribute to the developments of these anomalies. It has been shown that the seizure and migraine preventing drug, Topamax contributes to the development of craniofacial anomalies such as cleft lip and palate.
Topamax and its Effect on Pregnant Women
In 2008, a scientific study published in Neurology indicates that women taking Topamax at the time of pregnancy significantly increases the risk of cleft lip and palate birth defects. As per the article, “Topiramate in Pregnancy: Preliminary Experience from the UK Epilepsy and Pregnancy Register,” of the 178 babies born, 16 had major birth defects. Four of the babies had oral clefts – 11 times more prevalent than the normal rate. More and more cases around the world are being reported which led the FDA to issue serious warnings on Topamax. This medication has been rated by the FDA as Pregnancy Category D, just a level above Pregnancy Category X which is totally prohibited for pregnant women. A pregnant woman, especially with special needs, has to be very careful when taking medications. She must always seek her doctor’s advice.