Topamax Lawyers for Cleft Palate and Cleft Lip

Austin Kirk

By Austin Kirk
Posted March 7, 2011


Nearly three years after our lawyers first wrote on this blog about the potential risk of cleft lip and cleft palate from Topamax side effects, the FDA has announced that new warnings will be added to the antiseizure and migraine medication. The Topamax lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for children born with a cleft lip or cleft palate from Topamax.


On Friday, the FDA issued a drug safety communication warning about the risk of Topamax cleft lip and Topamax cleft palate birth defects. The agency warned healthcare professions and patients that the use of Topamax or generic topiramate during pregnancy may increase the risk of oral clefts when compared to other epilepsy drugs.

According to a press release issued by the FDA together with the new warnings:

Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate [Topamax] during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.

Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdon Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.

The FDA has changed Topamax’s classification from a Pregnancy Category C drug to a Pregnancy Category D drug. A Pregnancy Category C drug means that fetal risks are suspected due to animal testing, but no conclusive human testing has confirmed that risk. A Category D classification means that there is evidence from human clinical testing of fetal risk, but that in some cases the risk may be acceptable due to the drug’s potential benefits to the patient.


The Topamax birth defect lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations to help individuals determine whether they may be entitled to compensation as a result of a drug manufacturers’ failure to warn about the Topamax cleft lip and cleft palate side effects. To review a potential claim, request a free consultation with a Topamax lawyer.

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