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Topamax Birth Defects FAQ

What is Topamax?

Topamax (known generically as topiramate), is a medication used to treat patients with epilepsy who experience certain types of seizures. Topamax is also approved to prevent migraine head aches.

What is the concern about Topamax side effects?

Topamax has been linked to an increased risk of oral clefts—i.e., cleft palate or cleft lip—which can cause problems with eating or talking and can cause ear infections. According to data from the North American Antiepileptic Drug (AED) Pregnancy registery, infants exposed to Topamax during the first trimester had a 1.4 percent prevalence of oral clefts. That is compared to a 0.38 to 0.55 percent prevalence in infants who were exposed to other antiepileptic medications and a 0.07 percent prevalence in infants not exposed to any antiepileptic medications.

What does the FDA say about Topamax and pregnancy?

On March 4, 2011, the US Food and Drug Administration (FDA) issued a warning that data indicated a link between women taking Topamax and topiramate while pregnant had an increased risk of having a baby with cleft lip or cleft palate (known together as oral clefts). According to the FDA, research showed that infants exposed to Topamax or topiramate during the first trimester of pregnancy were at an increased risk of oral cleft.

As a result, Topamax has been reclassified to Pregnancy Category D, meaning that there is evidence of human fetal risk based on human data.

Health care professionals have been advised to strongly weigh the risks and benefits of Topamax and topiramate when prescribing it to women of childbearing age because the development of oral clefts can occur before the woman is aware she is pregnant.

Can Topamax birth defects--like Topamax Cleft Palate--be treated?

Yes, oral clefts can be treated, often with surgery to close the lip and/or palate. That surgery normally happens in the first year of life. Prior to that, however, oral clefts can lead to problems with eating or talking and can cause ear infections.

While surgery can help correct an oral cleft, insurance companies may sometimes balk approving benefits to be paid for cleft palate or cleft lip surgery. Such surgery may be considered elective or cosmetic, and parents need to be aware of this.

Are there lawsuits concerning Topamax Cleft Palate side effects?

Currently, no lawsuits have been filed regarding Topamax. Women who have taken Topamax while pregnant and have given birth to infants with oral clefts can speak to a lawyer to discuss their legal options.