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Topamax®

Topamax® (topiramate) is prescribed to reduce the frequency of certain types of seizures in epileptic patients. It also is used to prevent migraines, although is not effective if a migraine has already begun. About 32.3 million prescriptions for Topamax® were filled from January 2007 through December 2010.

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 lip and cleft palate, together referred to as oral clefts.

Data from the North American Antiepileptic Drug Pregnancy Registry showed that babies born to mothers who had taken Topamax® during the first trimester of their pregnancies had a greater chance of having oral clefts than either babies born to mothers taking other antiepileptic medications or babies born to nonepileptic mothers who were not taking any antiepileptic drugs at all.

Cleft Lip and Palate Data

The data reviewed by 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

In the United Kingdom, the Epilepsy and Pregnancy Register showed a 16-fold risk of oral clefts in the Topamax® group of infants compared to the regular population.

FDA Safety Announcement

The FDA announcement cautioned health care providers to carefully consider the benefits and risks 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. Physicians 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 intend to become pregnant while on the drug

Fetal Growth and Environmental Toxins

All fetuses in their early stages of development have cleft lips and palates (the roof of the mouth). These facial structures begin to join at the sixth week of fetal life and are fully fused 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 cause these birth defects.

For more information, contact a Topamax® birth defect lawyer today.