For children who develop a cleft lip or cleft palate after exposure to Topamax prior to birth, fixing the problem can take years of surgery, medical intervention and therapy. Children born with severe oral clefts may require the help of not only a surgeon, but also specialists, dentists, orthodontists and speech therapists. As the children grow, they may require further surgeries, to ensure the problem does not get worse as the jawbone grows and develops.
In other words, an infant born with a cleft lip or cleft palate could spend 18 years undergoing medical treatment and therapies.
What's more, the child is going through this at a vulnerable time. Childhood is already filled with insecurities about not fitting in. Children born with an oral cleft may suffer from social stigma not only because of their appearance but because their speech may be different from the children around them. This can lead to further insecurities.
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Not all families can afford the expenses associated with oral cleft treatment. Even with insurance, families might have massive out-of-pocket expenses to cover the various medical treatments and therapies.
Because of the reported link between the use of Topamax during pregnancy and a risk of oral clefts, the US Food and Drug Administration has changed Topamax from a Pregnancy Category C to Pregnancy Category D. Category D indicates that there is evidence from human fetuses that there is a potential risk to babies exposed to Topamax prior to birth.