Topamax Birth Defects Warning Released by FDA

Topamax (Topiramate) use by pregnant women significantly increases the risk of a child born with a cleft lip or cleft palate, according to an FDA report. Topamax is a drug approved by the FDA to treat seizures in people with epilepsy, but is also used off-label to prevent migraine headaches, fight alcoholism, deal with obesity, and treat bipolar disorder. Due to this increased risk of Topamax birth defects, the FDA is changing Topamax's rating from a category C drug to a category D drug. This change means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations.

When prescribing it to women of childbearing age…alternative medications that have a lower risk of birth defects should be considered.

This FDA warning stems from research from the North American Antiepileptic Drug (AED) Pregnancy Registry, which showed that infants whose mothers used Topamax had a 1.4% chance of being born with oral clefts, compared with a .38-.55% chance for infants exposed to different antiepileptic drugs and a .07% chance for those infants not exposed to any antiepileptic drug. Similar results were also found by the United Kingdom Epilepsy and Pregnancy Register.

Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said, "When prescribing it to women of childbearing age…alternative medications that have a lower risk of birth defects should be considered." Women of childbearing age are urged by the FDA to discuss alternative drug options with their doctor before using Topamax, and for those who become pregnant while using Topamax to immediately contact their doctor.

Oral clefts are when parts of the lip or palate do not fuse together during the first trimester of pregnancy. Oral clefts can be particularly damaging to infants, and can put unnecessary pressure on the mother after having a baby. As well as cosmetic effects, cleft lips and palates can affect a child's ability to eat or speak, and can also cause ear infections.

Though surgery can usually fix the defect and restore the appearance of a child's face, the cost of this surgery is often prohibitive, and may not fully restore a child back to normalcy. Women who have taken Topamax and gave birth to children with oral clefts may be entitled to compensation. To discuss whether you are eligible for legal recourse, contact a dedicated Topamax attorney for a free case evaluation by completing the form on the right.