A Warning Regarding Topamax and Neurodevelopmental Disorders

Between 2003 and 2009, Topamax was widely heralded by manufacturers and health professionals as a trusted solution for controlling seizures and preventing migraines. Many expectant mothers, eager to manage their history of seizures or migraines, relied on this endorsement, believing it to be safe during pregnancy. Yet, in a concerning turn of events, litigation and subsequent FDA interventions have revealed the medication’s potentially harmful effects on both pregnant women and their offspring. Disturbingly, emerging evidence suggests the risks may be even graver than initially believed.

Current research indicates a possible association between prenatal exposure to Topamax and an elevated risk of neurodevelopmental disorders in children, primarily Autism Spectrum Disorder (ASD) and intellectual disability. In recent years, the safety of various medications during pregnancy has come under scrutiny. Like the situation with acetaminophen (Tylenol), it’s deeply concerning to think that women, trusting in the endorsements of Topamax, the pharmaceutical companies that produced it, and the retail stores that sold it, may have unknowingly jeopardized the health and well-being of their unborn children.

Our law firm has filed a mass tort litigation case regarding the retail sale of acetaminophen taken by pregnant women whose child was subsequently diagnosed with Autism Spectrum Disorder (ASD). Emerging research suggests that both Topamax and acetaminophen taken during pregnancy may be linked to a heightened risk of autism in children. When discussing what medications our clients had been taking in the Tylenol cases, we found that some of these women were also prescribed Topamax during pregnancy between 2003 – 2009. 

This combined intake raises questions about potential cumulative or synergistic effects on fetal development. The intertwining of these drugs and their potential impacts emphasizes the pressing need for rigorous research and clear guidelines on medication use during pregnancy. The onus is on both pharmaceutical companies and for-profit retailers to ensure that their products are safe, especially for vulnerable populations like pregnant women and their unborn children.

Topamax and Autism Litigation May Reemerge After Acetaminophen Research

Unlike the situation with acetaminophen, the Federal Drug Administration (FDA) has taken notice of the adverse effects of Topamax for pregnant women and their children and has issued warnings about the pharmaceutical. In 2011, the FDA warned that Topamax, when used during pregnancy, can increase the risk of cleft lip and cleft palate birth defects in babies.

“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.”

FDA

Additionally, the FDA classifies drugs into various categories based on their potential risks and benefits during pregnancy, as it is of paramount importance to ensure the medications taken by the expectant mother are safe for both her and the developing fetus. The FDA elevated Topamax from a pregnancy Category C drug (not shown to be harmful to human fetuses) to a Category D drug: “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.”

Category D makes clear that there is concrete evidence of risk to the human fetus based on studies or adverse reactions. However, the drug may still be prescribed if the potential benefits to the mother outweigh these risks. Topamax, an antiepileptic medication, only now falls under Category D – it was a Category C drug between 2003 – 2009. This implies that while there’s credible evidence indicating that Topamax could harm the fetus, there might be scenarios where its therapeutic benefits for the mother could make its use necessary. Given this risk, it is crucial for pregnant women and those planning to conceive to discuss the implications of taking Topamax with their healthcare providers. 

Litigation definitively proved pharmaceutical manufacturer Janssen’s liability for birth defects caused by pregnant women taking Topamax. In 2013, a series of jury trials awarded millions of dollars to the affected families. Janssen appealed these cases and lost. Subsequently, the outstanding Topamax mass tort litigations were settled by 2016. 

The FDA, on numerous occasions, has been outpaced by mass tort and pharmaceutical litigations initiated by aggrieved plaintiffs. The imperative alerts about Topamax’s potential to cause birth defects and its adverse impact on expectant mothers and their offspring emerged regrettably late for numerous families. This underlines our urge to engage with women who placed their trust in Topamax’s safety between 2003 and 2009. 

Experience shows that mass tort actions against pharmaceutical behemoths can catalyze wider societal reforms and even prod the FDA into action. Ideally, regulatory intervention should precede litigation (or ideally, prevent litigation by preventing harm), but the present reality strengthens our resolve. We remain committed to championing the cause when emerging scientific data reveals detrimental drug effects, especially when regulatory bodies like the FDA appear slow to respond.

Addressing the Emotional and Financial Challenges of Autism

Watts Law Firm LLP is actively reviewing cases involving mothers who took Topamax between 2003-2009 and whose children were subsequently diagnosed with autism or intellectual disabilities. We had noticed during our intake with women who took acetaminophen during pregnancy and subsequently had a child later diagnosed with Autism Spectrum Disorder (ASD), some of these women also took Topamax from 2003 – 2009. We therefore are opening new litigation for women and children who suffered adverse effects of Topamax. 

Families with a child diagnosed with autism often find themselves navigating a complex maze of challenges that extends far beyond the initial diagnosis. Firstly, there’s the emotional weight of coming to terms with the fact that their child will experience the world differently. Routine daily tasks that many take for granted, such as communication, social interaction, and sensory processing, may become pronounced hurdles for the child. As a result, parents often require extensive education and training to become their child’s primary advocate and caregiver. Moreover, the financial implications can be immense. From early intervention therapies, specialized schooling, to lifelong care, the costs quickly add up, placing significant strain on the family’s resources. Additionally, parents often face societal stigma and misunderstandings about autism, leading to feelings of isolation and loneliness. Siblings may also grapple with a mix of emotions, ranging from confusion to resentment, requiring their own set of support. The family unit, as a whole, undergoes a transformative journey of which they need assistance and support. 

For families grappling with the myriad challenges of raising a child with autism, a lawsuit can represent more than just a claim for compensation; it can be a powerful avenue of advocacy and change. Pursuing legal action can provide these families with the financial resources to better manage the substantial expenses related to treatments, therapies, and specialized care. Beyond the immediate monetary relief, a lawsuit amplifies their voice, highlighting systemic oversights or negligence that might have contributed to their circumstances. It draws attention to potential misdeeds of pharmaceutical companies or other entities, urging them to ensure that such oversights are not repeated in the future. 

Furthermore, lawsuits can spur policy and regulatory changes, driving higher standards of safety and transparency within the pharmaceutical industry. For many families, joining a lawsuit also offers a sense of empowerment, solidarity, and hope. It signifies their commitment to not only seeking justice for their own family but also preventing other families from facing similar hardships. Families feel empowered when they know their struggles are not in vain; they can use their hardships and subsequent actions to prevent further harm to innocent families. 

Through the Topamax revelations, Watts Law Firm LLP emphasizes the critical role of legal advocacy in defending society’s most vulnerable. We believe in the power of uniting voices, demanding transparency, and holding institutions accountable. Joining Watts Law Firm LLP, our clients express a collective ambition: to ensure safety for future generations and to spotlight the importance of informed decision-making in medication choices during pregnancy.

FAQs about Topamax Litigation and Autism

Is Topamax Safe To Take During Pregnancy?

While we cannot provide medical advice, we strongly recommend pregnant women to consult their healthcare providers about all medications, particularly Topamax, especially given the emerging research and potential risks. The FDA has issued three serious warnings about Topamax: 

• 1. Risk of Birth Defects: The FDA warned that Topamax, when used during pregnancy, can increase the risk of cleft lip and cleft palate birth defects in babies. Cleft lip and cleft palate are facial and oral malformations that occur very early in pregnancy while the baby is developing inside the womb. These defects can happen when a baby’s lip or mouth does not form properly during pregnancy.
• 2. Category D Medication: In light of the findings that suggested a potential risk of oral birth defects, the FDA classified Topamax as a “Category D” medication for pregnant women. Drugs under this category have evidence of human fetal risk based on adverse reaction data, but potential benefits might warrant the use of the drug in pregnant women despite the potential risks.
• 3. Recommendations for Women of Childbearing Age: The FDA advised that healthcare professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age, particularly when treating conditions not usually associated with permanent injury or death. Alternative medications that have a lower risk of birth defects should be considered. Additionally, the FDA emphasized the importance of effective birth control for women of childbearing age taking Topamax and to talk to their healthcare professionals about other treatment options if they are planning to become pregnant.

However, these warnings from the FDA only came subsequent to many pregnant women being prescribed Topamax between 2003 – 2009. These warnings were not issued during this time, and women were left in the dark about these adverse effects to their pregnancies and children. 

Can I join a Topamax Class Action lawsuit?

Our lawsuits concerning Topamax are distinct from class action suits. We are diligently representing individual families in which mothers consumed Topamax between the years 2003-2009, leading to subsequent diagnoses of ASD or intellectual disabilities in their children. This approach is characterized as “mass tort litigation.” At this time, as we are filing mass tort litigation involving acetaminophen and autism, we are finding that some of the women we speak to also took Topamax during their pregnancies. If that is the case, we can therefore consider additional or alternative claims for those families regarding the dangers and consequences of Topamax.

Who may be eligible to join our Topamax mass tort lawsuit?

If you consumed Topamax between 2003 – 2009 during pregnancy and later discovered your child was diagnosed with Autism Spectrum Disorder (ASD) or intellectual disabilities, you may be eligible to join our Topamax lawsuits. Many of our clients feel a profound sense of betrayal and powerlessness when a drug they trusted to be safe turned out otherwise. Many in this position feel that they were kept in the dark, that the truths about the potential risks of the drugs were deliberately obscured. Pharmaceutical companies and retailers, prioritizing profits over safety, dismissed the well-being of countless innocent lives, leaving families to grapple with unforeseen challenges. 

Such feelings are not misplaced; there are compelling indications that corporations prioritize profits over patients. However, by choosing to engage in mass tort litigation, you are not only seeking compensation for your own experience but are also embarking on a mission of greater societal importance. Every lawsuit filed is a voice against this systemic neglect, aiming to usher in transformative changes. It’s about taking a stand, not just for personal justice, but to ensure that future mothers and families are shielded from such avoidable harm. Our litigation endeavors not only to secure compensation for those affected but also to propel a much-needed change in the pharmaceutical landscape, holding companies accountable and preventing further harm.

Disclaimer: This page is for informational purposes only and does not constitute legal advice.