Topamax Birth Defect Risk
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Topamax®, a drug prescribed to treat certain types of seizures in epileptic patients, has been shown to cause birth defects when taken during the first trimester of pregnancy. The drug is also used to prevent migraine headaches, but does not work once the headache has begun.
The U.S. Food and Drug Administration (FDA) issued a safety communication about the risks of Topamax® (topiramate) to alert women of childbearing age.
Cleft Lip and Cleft Palate
Based on data from the North American Antiepileptic Drug Pregnancy Registry, Topamax® taken during the first 12 weeks of pregnancy increases the risk of a baby being born with cleft lip and cleft palate. The research showed that the prevalence of oral clefts is:
- 1.4 percent in babies born to mothers taking Topamax®
- 0.38 to 0.55 percent in babies of mothers taking other antiepileptic drugs
- 0.07 percent in infants of mothers who were not epileptic and were not taking any medication for epilepsy
The safety announcement warns healthcare professionals and patients about these risks.
The FDA advised health care providers to weigh the risks against the benefits of prescribing Topamax® to epileptic women of childbearing age, and to consider treating these patients with other medications.
The agency advises women with epilepsy to take contraceptives if they are of childbearing age and to tell their doctors if they intend to become pregnant or if they do become pregnant. They also are warned not to stop taking Topamax® abruptly but to first speak with their doctors about their epilepsy medication. Stopping Topamax® suddenly puts the epileptic patient at risk of having seizures with all of it concomitant consequences.
Oral Clefts Development
Cleft lip and cleft palate, referred to together as oral clefts, occur when something interferes with fetal development between the sixth and 11th week of life. That is the time when the lips and palate, formerly “cleft” or split, join together at the midline of the face. Topamax has been found to interfere with fetal development if taken during the first trimester of a woman’s pregnancy.
Cleft lip and cleft palate can extend from a small indentation in the upper lip to a channel that runs into the roof of the mouth (the palate) and nose.
Complications of Cleft Lip and Cleft Palate
Complications from these malformations range greatly depending upon the location and size of the cleft. They can cause all or only some of the following problems:
- Breathing difficulties
- Eating problems
- Ear infections and loss of hearing
- Delays in speaking and language
- Dental problems
- Psychological and social difficulties
Consult a Topamax® Birth Defect Lawyer
If your baby is born with cleft lip or palate and you have a history of taking Topamax® while pregnant, contact an attorney for birth defects. You and your baby should be able to collect financial compensation.
