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Topamax

Discover the Truth about Topamax and its Potential Side Effects

Hoffman DiMuzio gives you the information you need about Topamax and birth defects

Rationally, we understand that most medications have some type of side effects. But then a drug like Topamax is especially dangerous, since its use wasn’t confined to its intent. The devastating birth defects speak for themselves.

What is Topamax?

Topamax is a pharmaceutical manufactured by Ortho-McNeil Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Topamax (generic: topiramate) was originally approved by the FDA to treat patients with epilepsy to prevent certain types of seizures. Topamax was also approved for use in the prevention of migraine headaches, but not to treat the pain associated with migraines. Unfortunately, Ortho-McNeil Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, promoted Topamax as a treatment for psychiatric disorders without applying for proper approval from the FDA.

Why is Topamax unsafe?

Taking Topamax (topiramate) drug during pregnancy raises the risk of oral cleft birth defects, such as cleft lip and cleft palate. Mothers who took the drug during the first trimester had children born with clefts or other oral birth defects. Some children were born with other defects like hypospadias (a malformation of the urethra in boys), or other major congenital malformations. When prescribing Topamax to women of childbearing age, physicians carefully must consider and discuss the benefits and risks of Topamax with their patients. Alternative medications that have a lower risk of birth defects should be considered.

Ortho-McNeil Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, promoted Topamax as a treatment for psychiatric disorders.  Ortho-McNeil did this even though they never applied for proper approval from the FDA to market and sell Topamax for psychiatric disorders..

Were humans treated like white mice in a lab? In many ways – Yes. Topiramate was previously classified as a pregnancy category C drug, which essentially means that data from animal trials suggested potential birth defects. Unfortunately, no human clinical trials were submitted to the FDA to establish the pregnancy category C drug classification. The new FDA warning changed topiramate to a pregnancy category D drug classification, which means there is positive evidence of fetal risk based on human data.

FDA Warning links Topamax to Birth Defects

On March 4, 2011, the FDA issued a warning alerting patients that Topamax raises the risk of birth defects. Topamax (generic: topiramate) was originally approved to treat epilepsy. However, taking Topamax drug during pregnancy raises the risk of oral cleft birth defects, such as cleft lip and cleft palate. Mothers who took the drug during the first trimester had children born with clefts or other oral birth defects. Some children were born with other defects like hypospadias (a malformation of the urethra in boys), or other major congenital malformations.

Topamax was approved by the FDA to treat patients with epilepsy to prevent certain types of seizures. Topamax was also approved for use in the prevention of migraine headaches, but not to treat the pain associated with migraines. Unfortunately, Ortho-McNeil Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, promoted Topamax as a treatment for psychiatric disorders without applying for proper approval from the FDA.

Medications other than Topamax were available to prevent certain types of seizures, prevent migraine headaches, and treat psychiatric disorders. Physicians and their patients should be able to discuss the benefits and risks presented by different medications. This is why it is important for manufacturers like Ortho-McNeil to present all of the benefits and potential risks to the FDA prior to selling pharmaceuticals. This is also why it is so dangerous for manufacturers like Ortho-McNeil to market their drugs to physicians and patients for treatment of medical conditions that were never approved by the FDA. The alternatives to Topamax have a lower risk of birth defects should be considered.  When prescribing Topamax to women of childbearing age, physicians carefully must consider and discuss the benefits and risks of Topamax with their patients.

Were humans treated like white mice in a lab? In many ways – Yes. Topiramate was previously classified as a pregnancy category C drug, which essentially means that data from animal trials suggested potential birth defects. Unfortunately, Ortho-McNeil did not submit any human clinical trials to the FDA to establish the pregnancy category C drug classification. The new FDA warning changed topiramate to a pregnancy category D drug classification, which means there is positive evidence of fetal risk based on human data.

Ortho-McNeil was fined $6.14 million by the FDA for this off label marketing strategy on May 21, 2010. FDA findings suggested there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions. Ortho-McNeil undoubtedly made more money selling Topamax by urging physicians and patients to take the drug to treat conditions for which it was never tested or approved. Just how much money did Ortho-McNeil make selling Topamax? More than 32 million topiramate prescriptions were dispensed to approximately 4.3 million patients from January 2007 through December 2010.

Speak with an accomplished attorney about your case

Did you take Topamax and give birth to a child who experienced a birth defect? Call Hoffman DiMuzio to discuss your child’s right to file a claim against Ortho-McNeil.

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Joseph J. Hoffman, Jr.
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Kenneth A. DiMuzio, Sr.
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An attorney with over 45 years of professional experience, Mr. DiMuzio concentrates his practice on personal injury and workers’ compensation matters. A graduate of Georgetown University Law School and a native of Gloucester County, Mr. DiMuzio has been honored time and again for his professionalism and ethics in the practice of law.

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