Topamax and Pregnancy

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Topamax®

The anti-convulsion drug Topamax® is the subject of a warning issued by the U.S. Food and Drug Administration (FDA) due to the risk of birth defects. The medication, and its generic equivalents, (topiramate), have been found to cause serious birth defects called oral clefts. These defects, which include cleft lips and cleft palates, are 20 times more likely in women who take Topamax® during pregnancy than untreated women.

If your baby is born with cleft lip, contact one of our Topamax attorneys today.

Is Topamax® Safe During Pregnancy?

Topamax® was previously classified as a pregnancy category C drug, meaning that animal studies had shown possible risks to a human fetus, but that there was no current evidence from study in humans. After the recent evidence showing the increased risk of birth defects, the FDA has re-classified it as a pregnancy category D drug. Pregnancy category D drugs have been shown to cause birth defects in humans, but may be beneficial enough to warrant use in certain women.

The only pregnancy category worse than D, are pregnancy category X drugs, which carry such risks of birth defects that women should not take them for any reason during pregnancy. The risks of cleft lip and cleft palate is high enough that the FDA recommends women of child-bearing age not take Topamax® or use some form of contraceptive while taking the medication.

The risk of birth defects is 20 times higher in babies whose mothers take topiramate than those who do not take anti-epilepsy drugs. Women who took other anti-epilepsy drugs have an increased risk of birth defects, but Topamax® users are 4 times more likely to give birth to infants with birth defects than any other epilepsy treatment.

Topiramate and Pregnancy Side Effects

Oral clefts, which include cleft lips and cleft palates are caused by taking Topamax® during the first trimester of pregnancy. Cleft lip and palate are caused when the structures that form the lips and palate don't fuse during development, leaving a gap. Oral clefts can usually be fixed with surgery.

Contact a Topamax® Cleft Lip Attorney

If your child has suffered a birth defect because of a medication treatment, you have legal options, which include filing a lawsuit. The manufacturer is responsible for protecting the safety of its users. Contact our Topamax birth defect attorneys for a free case review.