Topamax / Topiramate Side Effects

The dangerous drug attorneys at are currently assisting the families of children who were born with a cleft lip or cleft palate as a result Topamax or topiramate exposure. If your child has needlessly suffered as a result of Topamax or topiramate side effects, contact an experienced trial lawyer today.


Topamax (topiramate) is an anti-convulsant used to treat certain types of seizures in persons who have epilepsy. It is also used to prevent migraines. Studies have shown that Topamax/topiramate can result in serious birth defects such as cleft palate or cleft lip. Our law firm is offering free consultations to parents of children who suffer from the side effects of Topamax and are interested in learning more about their legal rights.


At, our dangerous drug lawyers are presently investigating claims involving Topamax and topiramate. If you have used Topamax or topiramate and have a child with birth defects, contact us immediately. Call 1-800-918-4559 to speak with a Topamax or topiramate lawyer.

FDA Warns of Topamax Cleft Lip and Topamax Cleft Palate Risk

On March 4, 2011, the U.S. Food and Drug Administration, FDA, notified healthcare professionals and the public of an increased risk for the development of cleft lip and cleft palate in infants whose mothers received treatment with Topamax while pregnant.


According to the FDA, data from the North American Antiepileptic Drug Pregnancy Registry reflect an “increased risk of an oral cleft in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4% prevalence of oral clefts, compared with a prevalence of 0.38% – 0.55% 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%.”


Based on this information, the FDA has reclassified Topamax as a “Pregnancy Category D” medication. Pregnancy Category D indicates that there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but that in certain situations, the use of the drug in pregnant women may be warranted, despite the potential risks. The FDA will require a Topamax labeling change to alert patients and healthcare providers of the increased risk of cleft lip and cleft palate associated with Topamax therapy.

Topamax Side Effects

Topamax can result in serious birth defects such as cleft palate or cleft lip. These birth defects occur when parts of the lip or palate fail to completely fuse together. The defect can result in a small, notched lip or in extreme cases, an open groove that extends from the roof of the mouth to the nose. Cleft lip and cleft palate birth defects can cause problems eating and communicating, and can increase the risk of ear infections.


A scientific study, published in Neurology in 2008, established that taking Topamax significantly increases the risk of birth defects. The published study reviewed 203 pregnancies. Of these, 178 resulted in a live birth. Overall, the rate of oral clefts observed was 11 times more prevalent than the normal rate. Due to these and other serious side effects, the United States Food and Drug Administration (FDA) issued a warning for patients taking Topamax. The warning was raised to Category D, which means there is positive evidence of human fetal risk.

Contact Our Topamax/Topiramate Attorneys

As a consumer and a patient, you have the right to trust your medication is safe. Tragically, this is not always the case. When a pharmaceutical company acts negligently, its actions can result in serious side effects. Victims however, may recoup damages through a successful product liability claim against the drug’s maker.


Well versed in the product liability laws that protect consumers, our Topamax and topiramate attorneys have handled countless lawsuits involving harmful pharmaceuticals. If your child experienced serious side effects, contact us today and discuss your potential birth defect lawsuit with an experienced Topamax and topiramate lawyer.


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