Dangerous Drugs

Topamax Caused Birth Defects, Lawsuits Allege

This Alert Affects:

Women who took Topamax (topiramate) while pregnant and delivered babies with birth defects.

Janssen Pharmaceuticals
Side Effects
Birth defects including cleft lip and cleft palate
Intended Use
Topamax is prescribed to treat epilepsy and prevent migraine headaches. It is also used off label to treat other conditions including alcoholism, obesity, and bipolar disorder.
FDA Warning
On March 4, 2011, the FDA issued a safety announcement for Topamax after data suggested that women who took the drug while pregnant faced an increased risk of delivering infants with oral clefts. The agency announced that the drug's classification would change to Pregnancy Category D, indicating that human studies have shown the drug can harm a fetus, and that its label would include a stronger warning about oral defects.
What Can I Collect?
Reimbursement for surgery, rehabilitation, and other medical expenses, as well as compensation for pain and suffering.
Type of Lawsuit
Mass Tort

Since 2011, mothers have been filing lawsuits against the maker of Topamax, Janssen Pharmaceuticals. These women allege that the antiepileptic drug is defective, and when taken during pregnancy, can cause infants to develop cleft lips or cleft palates. According to the lawsuits, Janssen knew Topamax could enter an unborn fetus’ system and increase a child’s risk of developing birth defects, but failed to adequately warn physicians or patients about this dangerous side effect. The first lawsuit filed against Janssen came just three months after data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry showed that women who took Topamax while pregnant were three times more likely to deliver infants with oral clefts than those who took a different drug to treat their epilepsy.

If you took Topamax while pregnant and delivered a baby with a birth defect, ClassAction lawyers would like you to know that you may have legal options. With the help of an attorney, you may be able to collect compensation for your child’s injuries or other losses your family has incurred as a result of using Topamax. For more information, please fill out our free case review form today.

Mothers File Lawsuits After Data Supports a Link Between Topamax and Birth Defects

Topamax lawsuits accuse Janssen of failing to provide an adequate warning for Topamax, suppressing its knowledge that the antiepileptic could cause birth defects, and releasing a defective drug into the marketplace.

In 2011, the FDA published a safety communication citing a study from the NAAED Pregnancy Registry, which reported that women who took Topamax during their first trimester of pregnancy gave birth to infants with oral clefts at much higher rates than women who used a different antiepileptic drug while pregnant. According to the study, Topamax patients gave birth to infants with oral clefts at a rate of 1.4 percent, which was much higher than the rate for women who used other antiepileptic drugs (between .38 and .55 percent) and women who were not treated for epilepsy (.07 percent).

The UK Epilepsy and Pregnancy Register reported similar results, with patients who took topiramate (the generic of Topamax) delivering infants with oral defects at a rate of 3.2 percent. When compared to women who were not treated for epilepsy while pregnant, those using topiramate were sixteen times more likely to deliver a baby with an oral cleft.

In light of the data from both of the pregnancy registries, the FDA announced that it would change Topamax’s label to include a stronger warning for side effects including oral defects. The agency also announced that it would change the drug’s classification to Pregnancy Category D – indicating the drug has shown “positive evidence of human fetal risk based on human data.” Previously, Topamax was classified as a Pregnancy Category C drug, meaning data from animal studies suggested a link between the drug and birth defects, but data from human clinical trials was not available.

The FDA warned that oral clefts develop during the first trimester of pregnancy, which is usually before women know they are pregnant. The agency suggested women of childbearing age should consider alternative medications with lower rates of birth defects or use effective contraceptives.

Is This a Class Action?

Although some believe the Topamax lawsuits are continuing as a class action, they are actually proceeding individually. This means that plaintiffs will retain their right to an individual attorney, trial, and award. Class action lawsuits are often used in situations where people have suffered minor damages or losses; however, women who used Topamax have allegedly suffered extensive damages, including thousands of dollars in medical bills. These women are therefore suited for individual lawsuits, rather than a class action where the final award is split.

How Much Does a Lawyer Cost?

Defective drug lawyers will typically request one-third of the award if their client wins; however, if the lawsuit is unsuccessful, the plaintiff will not have to pay his or her attorney for any work done on the case.

Birth Defects Caused by Topamax

Mothers who took Topamax while pregnant have reported delivering infants with cleft lips and cleft palates, as well as heart defects.

Cleft lip: Either a small notch in the upper lip or a larger groove that runs into the gums or the roof of the mouth, a cleft lip is the result of improper formation of the upper lip while the child is in the womb.

Cleft palate: An opening in the roof of the mouth, a cleft palate occurs when the two sides of the palate do not fuse together properly. These birth defects can develop individually or together and are noticeable at birth.

Oral clefts can cause significant problems for children. These birth defects can affect speaking and eating, and may also cause other issues including ear infections and dental problems. A facial malformation such as cleft lip or palate can even cause psychological problems for children as they age. Although surgery is often used to close the cleft or gap in an oral cleft, these procedures can be expensive and time consuming.

Attorneys believe the maker of Topamax should be held responsible for releasing a potentially dangerous drug into the marketplace. Please contact us if you are interested in seeking compensation for your child’s pain and suffering, as well as reimbursement for surgery, rehabilitation, and special medical care.

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Case Resources

UK Epilepsy and Pregnancy Register Study, November 2008
Researchers find that women using Topamax while pregnant delivered children with major congenital malformations at a rate 11 times higher than those who did not use the drug.
NAAED Pregnancy Registry Study, 2010
Researchers find that women who used Topamax while pregnant were more likely to deliver children with major malformations and low birth weights.
FDA Safety Announcement, March 2011
The FDA warns that use of Topamax during the first trimester of pregnancy may put unborn children at an increased risk for developing cleft lips and cleft palates.