Cleft palate and cleft lip have long been thought of as malformations caused by genetic issues. This condition is often passed on from generations of family members. It can happen as the result of a complete syndrome, or simply as a genetic abnormality without a syndrome. While cleft lip and cleft palate are certainly not incurable (modern surgery can correct the problem with little-to-no scarring) parents are very interested in possible environmental factors that can contribute to the condition. Avoiding these environmental factors could save thousands of dollars in cleft lip or cleft palate surgery.
What causes cleft lip or cleft palate besides genetic disposition? The condition has been linked to mutations in the gene PHF8, usually resulting from problems in breathing, as PHF8 depends on molecular oxygen to develop properly. Maternal hypoxia is the most commonly identified problem, and this can result from a mother smoking or drinking alcohol while pregnant. However, other drugs have also been linked to cleft lip. These include pesticide (even partial exposure), retinoids, nitrate compounds, lead, crack, heroin and even some prescription drugs.
Recently some anticonvulsant drugs have been linked with cleft palate. Topamax is some such drug and was even singled out in a warning by the FDA. New evidence (within the last two years, since the FDA just made the announcement in March 2010) suggests that infants exposed to topiramate (Topamax) in utero have a significantly higher risk of under-developing and suffering from cleft lip and cleft palate.
What is the evidence? Much of it comes from animal testing and not human observation, though multiple species have shown the effects of structural malformations and craniofacial defects after taking a clinical dosage of the product. Therefore, the FDA believes that there is a significant risk of humans suffering the same malformations when taking Topamax during pregnancy.
Of course, each patient (along with her doctor) must weigh the pros and cons of taking Topamax. Convulsions could be damaging to the life of the fetus as well as the mother. Topamax can actually prevent injury and death in some cases.
However, doctors do advise women to stop using Topamax during pregnancy if possible, especially if the patient is taking the drug for reasons that are not life threatening (i.e. migraines). Doctors are advised to warn patients of the risks of Topamax and encourage women or women of childbearing potential to consider alternative forms of therapy.
In case you want to further decrease the odds of cleft lip or cleft palate, (besides avoiding sources of intoxication and pollution while pregnant) some sources have suggested that folic acid can reduce the incidence of clefting.
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