Topamax Side Effects And Birth Defects. The lawyers at our firm are currently offering free consultations to victims of Topamax (topiramate) birth defects and side effects. In July 2008, a study was published in the journal Neurology that found that babies born to women taking Topamax during pregnancy had an increased risk for birth defects, particularly cleft palate and genital birth defects. If a child you know suffers from birth defects that may be related to Topamax, we urge you to contact one of our Topamax birth defect lawyers as soon as possible.
Topamax is an anti-convulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson. Ortho-McNeil has since been organized under Janssen Pharmaceuticals Inc.
Generic versions of Topamax were approved by the Food & Drug Administration (FDA) in 2006. Topamax is approved to treat epilepsy in adults and children, as well as migraine headaches. Topamax is often prescribed off-label—meaning Topamax is not FDA cleared for this purpose—to treat bipolar disorder.
Topomax Birth Defect Lawsuit Settles
On March 7, 2014, a Pennsylvania trial jury returned a $3 million verdict against Janssen
Pharmaceuticals Inc. in a case that accused the drug maker of neglecting to warn a woman of the birth defect risks associated with use of Topamax during pregnancy. The case is Payton Anderson et al. v. Janssen Pharmaceuticals Inc. (case number 111201405) in the Philadelphia County Court of Common Pleas.
The case was brought in December 2011 by the Wisconsin family of 5-year-old girl over allegations that baby was born with a cleft lip. Her mother was continually prescribed Topamax to treat chronic migraines while pregnant.
The case is the third to have reached trial in Philadelphia; however, 130 more cases are pending as part of a mass tort litigation there. Janssen also announced that it reached an agreement to resolve numerous cases in Philadelphia court, including a similar lawsuit in which a mother’s use of Topamax at around the time of her child’s conception allegedly led her son to develop a cleft palate that has involved at least five surgeries. The family’s attorneys also argued that Janssen received reports as far back as 2000 that pregnant women taking Topamax had given birth to babies diagnosed with craniofacial defects, such as cleft lips and cleft palates, and did not request that the FDA include Topamax as a Pregnancy Category D drug.
Two other cases tried in Philadelphia involved verdicts in favor of the plaintiffs. In one case, a $4 million verdict against Janssen was found for a family in October. In another case, the family was awarded $10 million in damages in December. A fourth Topamax case went to trial in Philadelphia in late February. Meanwhile, in 2010, Janssen agreed to pay in excess of $81 million to settle a U.S. Department of Justice inquiry into off-label Topamax marketing.
FDA Issues Topamax Warning in 2011 of Increased Risk of Babies Born with Birth Defects Including Cleft Lip and Cleft Palate
When it was approved, Topamax received a pregnancy category C classification from the FDA, which means the drug’s effect had not been studied in pregnant women, although Topamax has caused harm to the fetus in animal studies. Topamax has been associated with birth defects, miscarriages, and decreased fetal weight in rabbits, rats, and mice, according to the prescribing information.
In March 2011, the FDA issued an alert that made Topamax a Category D medication.
The FDA warned that women of childbearing age who take Topamax when pregnant may experienced increased risks of their babies being born with birth defects around their mouths. Regulators warned that data revealed an increased rate for babies being born with cleft lip and cleft palate when their mothers took Topamax in the first trimester of pregnancy. Infants exposed to Topamax experienced a 1.4 percent rate of being born with mouth defects, which is more than three times greater that the risk seen with other seizure medications.
Johnson & Johnson and generic drug companies that market the drug, known as topiramate, which is sold under the brand Topamax, were required to add a stronger warning label about the drugs’ effect on pregnancies.
Additional Topamax Birth Defect Studies
The 2008 Topamax study published in Neurology was conducted by researchers at the Royal Group of Hospitals in Belfast, Northern Ireland. The research reviewed 203 women who became pregnant while taking Topamax for the treatment of epilepsy and found that the risk of birth defects increased by as much as 14-fold. The risk for birth defects was especially high in women who took Topamax in combination with another epilepsy drug, valproate.
Of the 178 live births that occurred, three babies whose mothers took Topamax alone and 13 whose mothers took Topamax along with other anti-epilepsy drugs were diagnosed with major birth defects. The other drugs included Frisium, Sabril, Epilim or Depakine, Zarontin, and Keppra, as well as the generic drugs carbamazepine, phenobarbitral, or phenytoin. Of thee births, four of the babies were born with cleft palates or cleft lips, which occurred 11 times more than would be expected among women not taking epilepsy medication. Four male babies were born with genital birth defects; two of these were classified as major birth defects. Minor birth defects included a hole above the buttocks, a flattened head, toe webbing, so-called “clicky” hips, and immature hip joints. The birth weights were not significantly lower than what is expected in the normal population.
Drugs to treat epilepsy are known to increase the likelihood of miscarriage and birth defects. Still, women suffering from epilepsy need to take these medicines to prevent seizures that may cause harm to the fetus. The researchers indicated that the birth defect rate associated with Topamax in their study was in line with those of other anti-seizure drugs, though a larger study is needed to draw definitive conclusions. Meanwhile, more birth defects did occur in women taking Topamax along with the drug valproate, or valproic acid, when compared to the birth defects seen in babies born to women taking other epilepsy drugs or other Topamax drug combinations.
Valproate is sold as Depakote by Abbott Laboratories and as Depakine by Sanofi- Aventis. Previous research has shown that valproate is associated with an increased risk of birth defects such as heart defects and spina bifida. Because the risk of birth defects associated with valproate is already well known, our Topamax birth defect lawyers believe that doctors who treat pregnant women with a Topamax-valproate combination may be liable for medical negligence.
Although the Neurology study was small, the study was the first to link Topamax to birth defects in humans, and also confirmed earlier animal studies that revealed evidence of fetal harm. The researchers who conducted the study said that the connection between Topamax and birth defects warrants further study. Three major databases currently track birth defects among babies born to women taking epilepsy drugs, but only one has, so far, provided information on Topamax. When the other databases report, the extent of Topamax’s association with birth defects should become clearer.
For now, many experts are advocating that Topamax use in women who plan on conceiving should be restricted to those in whom the drug is definitely needed for seizure control or other indications. Also, the mother should be informed of the potential risks to her child.
The Topamax birth defect lawyers at our firm believe that, given the evidence of fetal harm in animal studies, the maker of Topamax should have performed more studies to determine the drug’s effects on human fetuses, and should have provided stronger warnings about the possible danger.
In the years since receiving FDA approval for the treatment of migraines, Topamax has become one of the most widely prescribed drugs for the condition, which affects almost 30 million Americans. Women are three times more likely to suffer from migraines than men; women in their childbearing years are particularly vulnerable. Our Topamax birth defect lawyers believe the widespread use of this drug for migraines by women of childbearing age may have contributed to the occurrence of birth defects in thousands of children.
Legal Help for Victims of Topamax Birth Defects
If you or a loved one has given birth to a child who suffers from birth defects that might be the result of Topamax use, you have valuable legal rights. Please fill out our online form or call 1-800-YOURLAWYER to discuss your case with an experienced Topamax birth defect lawyer.
Topamax in the news:
Click here to view New York Times story: March 4, 2011 | Women Warned About Epilepsy Drug