Were you one of the thousands of
mothers prescribed Topamax during pregnancy?
Do you have a teenager diagnosed with Autism or an Intellectual Disability?
Manufacturers of Topamax products are potentially at fault in thousands of birth defect cases.
If you or a loved one have used Topamax products and had complications with your pregnancy, let our team of attorneys get you the justice you deserve.
Topamax is a drug that has been approved by the U.S. Food and Drug Administration (FDA) to treat epilepsy and prevent migraine headaches.1 It was first sold commercially in the U.S. in 1996. Topamax works by suppressing the rapid brain activity that precedes epileptic seizures.
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Topamax and Autism: The Evidence
Researchers from Norway, Sweden and Denmark published a report late last month in the medical journal JAMA Neurology, which found an association between the use of antiseizure medication (ASM) by pregnant women and intellectual disabilities in their children.
Drugs like Topamax are often prescribed to women suffering from epilepsy, especially during pregnancy, where a sudden seizure could result in injury to the mother and child, but the researchers note the risk of neurodevelopmental disorders linked to the medications’ use are uncertain.
In this latest study, the researchers looked at data from nearly 4.5 million children collected by a Nordic registry-based study based on the populations of Denmark, Norway, and Sweden between 1996 and 2017. The researchers looked at cumulative incidence in children at age 8 who were either exposed or not during pregnancy.
According to the findings, out of 21,634 children of mothers with epilepsy, 1.5% were diagnosed with an autism spectrum disorder (ASD) and 0.8% had some sort of intellectual disability. However, those numbers increased significantly among mothers who took Topamax during their pregnancy.
Topamax was linked to a 4.3% rate of autism and a 3.1% rate for intellectual disability. Overall, the drug was linked to a two to four-fold increased risk of ASD and intellectual disability.
Topamax Timeline Events
The following is a timeline of events in the discovery of Topamax symptoms of side effects (birth defects) in infants:
- 1979 — Topamax is developed by divisions of Johnson & Johnson.
- 1996 — Topamax is approved for the treatment of epileptic seizures.
- 2005 — Topamax is approved for the treatment of migraine headaches.
- 2006 — Generic topiragen is approved.
- 2008 – FDA Grants Pediatric Exclusivity for TOPAMAX®
- 2008 – UK Study Finds 14-fold increase in birth defects
- 2009 — Topamax patent expires and generic forms of the drug flood the marketplace.
- 2010 — Off-label promotion of Topamax results in Whistleblower lawsuits and $81 million in settlements.
- 2011 — FDA warning changed to category D, which means: “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.” This information was taken from Drugs.com list of FDA category ratings.
- 2014 — Simmons Hanly Conroy secures $3 million verdict against Janssen Pharmaceuticals.
- 2022 – Association of Prenatal Exposure to Antiseizure Medication With Risk of Autism and Intellectual Disability
What to Know About Autism Spectrum Disorder
ASD currently affects about 1 in 59 children. While the incidence is rising, it’s unclear if this results from increased diagnosis or increased occurrence.
Because people with autism are said to “on the spectrum,” an individual child may exhibit various symptoms that range from mild to severe. Some of the most common ASD symptoms include:
Lack of Social Skills
Children with autism have a hard time interacting with others. Those on the spectrum usually begin exhibiting social symptoms by the time they’re 8 to 10 months old.
Communications Problems
About 40% of kids with autism don’t talk at all. Between 25% and 30% develop some language skills in infancy but lose them later, and others don’t begin talking until later in life.
Patterns of Behavior
Many children with autism behave in ways that seem unusual or have unusual interests.
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Do I Have A Case
If you or a loved one have suffered from adverse effects from taking Topamax, you may be entitled to financial compensation.
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