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Topamax: Prescription Drug Linked to Birth Defects

The development of an unborn child is a delicate process, especially in the first trimester. With the dividing and changing of cells, even small outside influences can prove damaging during those first formative months.

Chemicals in many prescription drugs are harmful to fetuses. In particular, a drug called Topamax has been linked to birth defects.

The Curious Case of Topamax

Topamax is an anti-epilepsy drug that was recently reclassified as a category D drug by the Food & Drug Administration (FDA). In March 2011, the FDA released a safety alert which suggested that Topamax used during pregnancy could cause cleft lips and cleft palates, as well as male genital deformation. The alert was based on information from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

The NAAED’s information showed a 3.8 percent frequency of major birth defects in children exposed to Topamax during pregnancy compared to 1.3 percent in an unexposed group. Of the exposed group, 0.69 percent of infants suffered from cleft lips compared to the generally expected rate of 0.07 percent.

Although these numbers are based on uncontrolled study groups, the percentages are still alarming, especially considering that around 4.3 million people filled Topamax prescriptions between 2007 and 2010.

How Does the FDA Fit In?

The FDA is charged with oversight of the approval of prescription drugs and classification of their potential risks to human fetuses. With the public revelation of Topamax’s potential for birth defects, the FDA raised the drug’s classification to a category D drug.

Category D means there is human evidence that the drug can cause harm to an unborn child. The classification change came in March 2011, but it is unknown how long the FDA has known of Topamax’s strong potential for significant birth defects.

Making Them Pay

The manufacturers of prescription drugs that harm the most defenseless among us are responsible for the harm they cause. If you used Topamax during pregnancy and your child suffers from a birth defect, contact an experienced New York personal injury attorney to discuss your situation and your options.