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Antiepileptic Drug Topamax Causes Congenital Oral Defects

By October 23, 2012October 12th, 2023Pharmaceutical litigation, Topamax, Uncategorized

Published October 23, 2012 by

Topamax (topiramate) is an antiepileptic and antiseizure drug used to treat seizures in patients suffering from epilepsy. Topamax is also used to treat people suffering from migraine headaches. This anticonvulsant medication is manufactured, distributed, and marketed by Ortho-McNeil-Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson.

Though Topamax has been approved by the U.S. Food and Drug Administration (FDA), the drug’s label has recently been updated to reflect the significant health risk the antiepileptic drug poses to proper fetal development. The FDA released a warning in March 2011 about the inarguable link between the use of Topamax by pregnant women and the heightened risk of the development of congenital oral defects in their newborn babies. At the time of this warning, the FDA also re-categorized Topamax as a Pregnancy Category D drug, signifying the severe health risks it poses to unborn babies.

Birth defects caused by the use of Topamax in pregnant women include, but are not limited to, the following:

  • oral defects
  • cleft lip
  • cleft palate

In studies conducted to determine the safety of Topamax, data was collected demonstrating a severe threat to an unborn child’s health as a result of exposure to Topamax in the womb. Furthermore, there have been numerous reports of Topamax heightening the occurrence of congenital oral defects, such as cleft lip and cleft palate.

Though terminating use of Topamax during pregnancy will allow for proper fetal development, it has been understood that sudden termination of Topamax use can lead to an increased amount of seizures. It is important to consult with a physician if deciding to take Topamax while pregnant, as there is concrete evidence of Topamax caused birth defects.

Also, the use of Topamax after pregnancy must be given consideration if the mother decides to breast feed. It is known that Topamax is present in breast milk, and can compromise the health of a newborn child. If considering the use of Topamax while breast feeding, consult a physician.

If your newborn baby has suffered from the development of a Topamax-linked birth defect, contact a pharmaceutical product liability lawyer at Carey Danis & Lowe. Submit a claims form, and one of our experienced Topamax lawyers will provide you with a free legal consultation regarding your Topamax claim.

It is clear that the pharmaceutical giant, Ortho-McNeil-Janssen Pharmaceuticals Inc., neglected to inform healthcare providers and consumers about the serious negative health effects of Topamax use in pregnant women and its link to life-altering birth defects. In the battle to uphold consumer protection, our pharmaceutical product liability lawyers provide expert legal counsel to help you win the compensation you and your family so deserve.