Topamax Autism Lawyer

The Food Drug and Administration (FDA) recently announced an increased risk of developmental issues in children born to women who took Topiramate (brand name Topamax). Topamax autism lawyer, Jason Coomer, can advise you on your legal rights and potential compensation due to prenatal Topamax exposure. If you or a loved one has taken Topamax while pregnant and had a child diagnosed with autism, it is crucial to seek medical assistance for further guidance.

To explore a potential claim related to autism in children due to maternal Topamax usage, please get in touch with Topamax autism lawyer Jason Coomer. Further, reach out today by email, text or phone at 866-474-1477 (toll-free) to contact the Law Offices of Jason S. Coomer to begin the process of evaluating your claim.

What is Topamax?

Topiramate, commonly referred to as Topamax, is primarily prescribed for epilepsy and migraines. Pharmaceutical companies also market the drug for off-label uses such as bipolar disorder, headaches, eating disorders, fibromyalgia, depression, PTSD, alcoholism, sleep disorders, infantile spasms, autism, and more. The FDA advises women using Topamax to notify their healthcare provider if they are planning to conceive or are already pregnant. Patients should not discontinue medication without medical guidance. If you are pregnant, The North American (AED) Antiepileptic Drug Pregnancy Registry recommends joining the registry to monitor infant health outcomes.

Additionally, the FDA cautioned in May 2008 regarding an increased risk of suicidal thoughts and behaviors with topiramate use. This warning highlighted the importance of monitoring patients closely for any signs of worsening depression or unusual changes in behavior while on the medication. Healthcare providers were advised to inform patients and their families about this potential risk and to seek medical attention if any concerning symptoms arose.

Approved Uses of Topamax by the FDA by Topamax Autism Lawyer Jason Coomer

Ortho-McNeil Neurologics, and Noramco, Inc., divisions of Johnson & Johnson, both produce Topiramate. The FDA approved this anticonvulsant and antiepileptic medication in 1996 for treating epilepsy. In 2004, the FDA approved Topamax for treating migraines, either alone or in combination with other medications. As a Topamax autism lawyer, Jason Coomer commonly reviews studies and FDA announcements.

The Federal Food Drug and Cosmetic Act (FDCA) establishes a structured framework for approving new drugs and formulations for market distribution. Under the FDCA, the FDA can only market a new drug once it deems it safe and effective for its intended use. While the FDA approves drugs for specific uses, it does not regulate how physicians may prescribe them. Consequently, physicians can prescribe drugs for off-label uses.

Although physicians have the discretion to prescribe drugs for off-label use, the FDA strictly prohibits drug manufacturers from marketing or promoting drugs for uses not approved by the agency. This prohibition extends to labeling drugs with information about unapproved uses, which is considered illegal misbranding. The courts and the FDA emphasize that the FDCA mandates information disclosure for all intended product uses. Consequently, any promotional materials or statements suggesting unapproved uses render the product misbranded under FDCA regulations.

Topamax Use During Pregnancy by Topamax Birth Injury Attorney Jason Coomer

As a Topamax birth injury lawyer, Jason Coomer has researched the below 2011 announcement. Recent research has linked Topamax to increased risks of birth defects. Specifically, in February 2011, U.S. Health Officials, in collaboration with the FDA, highlighted Topamax's connection to birth defects, notably cleft lips and palates. These studies have shown higher rates of genital defects and other malformations in babies born to mothers who used Topamax during pregnancy, raising significant concerns about the use of this medication during pregnancy.

In response, the Food and Drug Administration (FDA) has emphasized the necessity for caution among pregnant women prescribed Topamax, strongly advising close consultation with healthcare professionals to explore alternative treatments and urges the prompt reporting of pregnancies while on the medication. These warnings emphasize the critical importance of acknowledging and discussing the potential risks associated with Topamax use during pregnancy with a qualified healthcare provider.

New Study Investigates Topamax Exposure and Autism Risk

A study published by the New England Journal of Medicine investigates the prevalence and characteristics of Autism Spectrum Disorder (WHO) among children exposed to topiramate (Topamax) in utero. It examines data from a national database, identifying children born to epileptic mothers who were exposed to antiepileptic drugs during pregnancy.

The findings suggest an increased risk of WHO among children exposed to topiramate compared to other antiepileptic drugs. Additionally, the study highlights the importance of monitoring the prenatal outcomes in children exposed to antiepileptic drugs. It emphasizes the need for further research into the specific risks associated with topiramate exposure during pregnancy.

Pharmaceutical Accountability and Regulation Information by Topamax Autism Lawyer Jason Coomer

Topamax autism lawyer Jason Coomer understands families confronting avoidable birth defects endure profound devastation. Instead of celebrating a new arrival, parents often find themselves facing severe disabilities in their newborn. They often fail to realize that they can hold accountable parties, including drug manufacturers who concealed information about defect-causing medications. Families prioritizing their child's health may not grasp the preventable nature of the defect until later, leading to feelings of anger and anguish.

Profit-driven manufacturers often promote many medications and products linked to birth defects, concealing dangers to enhance sales. While they may profit in the short term, they must face accountability for the lasting harm caused by their actions.

Discovering a drug company prioritized profits over safety, leaving their child with lasting health problems or worse, deeply distresses families. This discovery highlights the crucial role of pharmaceutical transparency and rigorous regulations in protecting the health of vulnerable populations.

How to Join a Topamax Autism Lawsuit?

Topamax autism lawyer, Jason Coomer, specializes in handling complex federal and Texas birth defect lawsuits. He collaborates with other attorneys focusing on autism-related cases nationwide and seeks compensation from negligent entities such as drug companies and medical providers. These entities may harm or kill infants or mothers by selling dangerous products without disclosing vital safety information. Families with children diagnosed with autism can rely on Jason Coomer, Texas Birth Defect Lawyer, for dedicated legal support.

Autism cases present some of the most challenging and emotionally taxing legal matters. Families dealing with autism-related birth defects face significant hurdles, including legal challenges and emotional stress. As experienced attorneys, we commit to delivering compassionate and effective legal representation. Our goal is to help families secure the compensation they deserve and hold responsible parties accountable for their child's condition. If your child has autism and you suspect a link to medication or other pregnancy factors, please contact the Law Offices of Jason S. Coomer for further assistance.

Contact Topamax Autism Lawyer

Topamax autism lawyer Jason Coomer works with other lawyers specializing in Topamax birth defect cases throughout the United States. This collaboration enables his law firm and others nationwide to better represent their clients by sharing information and working together effectively.

In his legal practice, Coomer deals with various cases involving birth injuries including lawsuits related to defective drugs. In fact, much of his expertise extends to defective drug mediation cases, where he advocates for clients affected by Topamax and other Antiepileptic Drugs (AEDs). If you or a loved one has experienced Topamax-related issues during pregnancy, leading to an autism diagnosis in your child, please reach out today by email, text or phone at 866-474-1477 (toll-free) to contact the Law Offices of Jason S. Coomer to begin the process of evaluating your claim.