Did you or a loved one take Topamax and give birth to a child with birth defects?

The FDA recently issued a warning for women taking Topamax who are of child-bearing age that the drug can cause an increased risk of birth defects. Topamax, market name for the drug topiramate, is prescribed to treat epilepsy and migraines, but has been used for off-label purposes like the treatment of bipolar disease. Last year, drug maker Johnson & Johnson was charged with and pled guilty to one count of a misdemeanor violation of the Food, Drug & Cosmetic Act for illegally marketing Topamax for uses not approved by the FDA and was fined $6.14 million in criminal fines.

Topamax originally contained a label warning pregnant women of the risks posed to the fetus when taking the drug, but human studies did not produce adequate data at the time. The FDA originally approved the drug for use in 1996 to treat epilepsy and again in 2004 to treat migraines. Between January 2007 and December 2010, an estimated 32 million people filled prescriptions for Topamax or its generic equivalent, making it one of the most widely-prescribed anti-convulsant drugs on the market, especially for women of child-bearing age.

Researchers estimate that 2.3 million Americans struggle with epilepsy, a disease that causes seizures, and another 30 million suffer from migraines. Women are three times more likely to suffer from migraines than men, especially in their child-bearing years. Topamax can affect the development of a fetus in the first five to six weeks of pregnancy, and women taking the drug may not know that they are pregnant. Topamax has also been found to decrease the effectiveness of oral contraceptives.

Birth defects were found in babies born to women taking Topamax based on the North American Antiepileptic Drug Pregnancy Registry (NAAED), which reported that of infants exposed to topiramate in the first trimester, 1.4 percent developed oral clefts, compared to just 0.38-0.55 percent of infants exposed to other anti-epileptic drugs. Based on these findings, the FDA changed the pregnancy risk categorization for Topamax from a category C to a category D. Category C means animal data has been collected that suggests potential fetal risks, but human studies have not yet adequately produced any data. Category D recognizes that there is a risk to the fetus based on human data, but that in certain patients, the benefits of continuing the medication during pregnancy may outweigh the risks.

The NAAED reported 178 total live births, of which three babies whose mothers had taken Topamax alone in the first trimester and 13 whose mothers had taken Topamax with another anti-epilepsy drug had major birth defects. Reported birth defects include cleft palates, cleft lips, and hypospadias, a genital defect in male infants. Cleft lips and palates occur in the first trimester of pregnancy when the tissue in the mouth is still forming. When there is a lack of tissue, a cleft develops, and when the baby is born, several surgeries are often required to fix the cleft within the first few years of its life.

Infants with cleft lips and palates struggle with eating, are prone to chronic ear infections and hearing loss, and often have language delay and misaligned teeth. Male infants born with hypospadias similarly can require several surgeries to correct the problem, and can suffer with the defect well into adulthood, if not treated properly.

While women taking the drug for the treatment of migraines may find safer alternatives in other drugs during their pregnancies, women who have epilepsy must remain on a treatment, otherwise the fetus is at risk for suffering worse effects. Seizures are more of a risk to the baby, because when the mother seizes, a lowered level of oxygen is delivered to the fetus, which can cause a drop in its heart rate.

The FDA is now warning doctors against prescribing the drug for women of child-bearing age, unless they have tried other treatments that have failed. If a woman in this category must take Topamax, doctors should talk with them about whether they plan to become pregnant and may even prescribe them an appropriate contraceptive that will not be affected by Topamax.

Topiramate is also a component of the weight loss drug Qnexa, which was rejected by the FDA earlier this year because of concerns regarding birth defects. However, Johnson & Johnson is continuing to push forward on development of the drug to ultimately get FDA approval. If approved, the drug could be distributed to a much larger segment of the population, increasing the number of potential birth defects from the drug.

If you or a loved one has taken Topamax or its generic equivalent during a pregnancy, and your baby suffered a birth defect, contact Van Wey Law.

Don't hesitate to contact Kay Van Wey at (800)489-5082 for a free, no obligation consultation.

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