Topamax® (also known as topiramate) (and its generic versions) is prescribed to reduce the frequency of seizures in patients with epilepsy.
It has also been prescribed for “off label” uses such as migraines.
In early March 2011, the U.S. Food and Drug Administration (FDA) issued a safety communication for patients and healthcare professionals about Topamax®.
The announcement warned of a link between Topamax® and cleft palate and cleft lip. Both are also referred to as oral clefts.
Birth Defects Linked to Topamax Include:- Cleft Lip
- Cleft Palate
- Other Birth Defects
Topamax® and anti-epilepsy drugs similar to it are within a class of drugs already known to increase the risk of birth defects. Babies born to mothers who had taken Topamax® during the first trimester of their pregnancies had an increased chance of having oral clefts compared to either babies born to mothers taking other antiepileptic medications or babies born to nonepileptic mothers who were not taking any antiepileptic drugs.
The FDA showed that the incidence of cleft lip and cleft palate was: - 1.4 percent in infants exposed to Topamax®.
- 0.38 to 0.55 percent in infants exposed to other antiepileptic drugs.
- 0.07 percent in infants whose mothers did not have epilepsy and were not taking antiepileptic medications.
The UK Epilepsy and Pregnancy Register reported a similarly increased prevalence of oral clefts (3.2 %) among infants exposed to topiramate monotherapy. This represents a 16-fold increase in risk compared to the risk in the background population (0.2%).
The FDA announcement warned health care providers to consider the risks and benefits of Topamax® when prescribing epilepsy drugs for women of childbearing age, especially when the drug is being considered for an illness (such as a migraine) that is not usually associated with permanent injury or death.
Doctors were advised to consider alternative treatments for women of childbearing age.
The FDA safety announcement told women of childbearing age that they should be using contraceptives and to tell their doctors if: - They became pregnant while taking Topamax®.
- They wish to become pregnant while on the drug.
Fetal Growth:
All fetuses in their early stages of development have cleft lips and palates.
These facial structures begin to join at the sixth week of fetal development and are fully joined together by the 11th week.
Any environmental agent or toxin that interferes with this stage of development can prevent these oral clefts from properly closing.
In that case, a baby may be born with a cleft lip, a cleft palate or both.
Topamax® taken during that period of fetal growth has been shown to potentially be linked to these types of birth defects.
What You Can Do & How We Can Help
We are currently willing to review potential Topamax birth defect claims from all 50 states.
If you or somebody you know has taken Topamax during pregnancy and given birth to a child with Cleft Lip or Cleft Palate or any other birth defect, you should contact us immediately for a free case consultation.
Call us at 866 FOX FIRM 24 hours a day or fill out any of the forms on this website. For more information, contact a Topamax® birth defect lawyer / attorney today.
Who We Are
The Fox Law Firm provides legal information and resources for injured individuals and their families in all 50 States. Our affiliated attorneys have successfully represented thousands of individuals in a wide variety of practice areas in federal and state courts throughout the United States. Because The Fox Law Firm has its cases fully prepared for trial and has the trial experience to succeed before a jury, most cases reach positive settlements prior to trial. The Fox Law Firm's affiliated attorneys have successfully represented thousands of individuals and have obtained over six hundred million dollars ($600,000,000.00) in settlements or jury verdicts for their clients. The initial consultation is free of charge, and if we agree to accept your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Do not delay - your rights and your compensation could be lost. If you or a loved one or friend is injured and may have a potential legal claim, call The Fox Law Firm now at 1-866-FOX-FIRM (Extension 245) or email us at
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Patients taking topiramate should not stop taking it unless told to do so by their health care professional.
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