The drug Topomax (topiramate) is prescribed for people with epilepsy to help control seizures and prevent migraines. However, new information released by the Food and Drug Administration (FDA) warns that taking Topamax during pregnancy increases the risk of birth defects, namely cleft lip and cleft palate (oral clefts). According to the North American Antiepileptic Drug Pregnancy Registry, women taking Topamax are 20 times more likely than women not taking an antiepileptic drug to have children with oral clefts.
Oral clefts occur when the lip or palate do not fuse together properly during the first trimester, causing indentations or grooves in the lip or from the roof of the mouth to the nose. A cleft lip or palate can interfere with eating, talking and hearing, and expensive reconstructive surgery is required to correct this condition.
As a result of the new data, the FDA will change the pregnancy category of topiramate to Pregnancy Category D - which means that there is positive human evidence of risk to the fetus. The drug was previously categorized as Pregnancy Category C (no positive evidence confirming risk to fetus in humans).
General information on birth defects
Prescription and over-the-counter medications can cause birth defects by causing damage to the fetus, which leads to abnormal development. Some drugs can also interfere with the functioning of the placenta, which decreases the amount of oxygen and nutrients supplied to the fetus (causing low birth weight and underdevelopment). Lastly, some medications may trigger contractions which can injure the fetus or cause premature labor.
In general, a fetus is most affected by teratogens (substances that cause birth defects) during the third to eighth week of development. However, some drugs can harm the fetus at any time during the pregnancy. Depending on when the drug is taken, teratogens can cause the fetus's organs to not develop correctly, or induce premature birth or miscarriage. Teratogenic drugs taken 20 days or more before conception may have no effect, or alternatively may induce miscarriage.
The FDA uses five pregnancy categories to classify drugs according to the risk of harm to a fetus when taken during pregnancy. A category of "A" or "B" means that studies show no evidence of risk to a fetus during pregnancy. Category C means that studies on animals have shown a possible adverse effect on the fetus, but the potential benefits of the drug may outweigh the risk. Category D indicates that there is positive evidence of risk to the fetus. The highest level of risk is Category X, which means that women who are or could become pregnant should not take this drug (i.e. Accutane). Drugs that the FDA has not yet classified are in Category N.
If you have taken Topomax (topiramate) during pregnancy and your child was born with birth defects, you may be entitled to monetary compensation for your past and future medical expenses, pain and suffering, and more. Oshman & Mirisola, LLP has successfully represented personal injury victims for more than 35 years. Our experienced birth defect attorneys are committed to fighting for your interests and giving you the best legal representation. Contact us at (800) 400-8182 or submit our online Contact Us form for a FREE consultation of your case. Let us help you get the justice you deserve.