The U.S. Food & Drug Adminstration (FDA) recently linked Topamax (generic: topiramate) to an increased risk of birth defects in children born to mothers that took the drug during pregnancy. More specifically, Topamax, the popular Epilepsy drug, which was also promoted “off-label” for psychiatric health has been linked to Cleft Lip and Cleft Palate birth defects.

What You Can Do & How We Can Help

The Schmidt Firm, LLP is currently accepting Topamax birth defect claims in all 50 states. If you or somebody you know has taken Topamax during pregnancy and given birth to a child with Cleft Lip or Cleft Palate, you should contact our law firm immediately for a free case consultation. Please click here to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

FDA Issues Topamax Warning

On March 4, 2011 the FDA required the manufacturers of topiramate (Topamax) to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects, including cleft lip, cleft palate, and genital malformations including Hypospadias.

However, the FDA had known of the birth defect risk three years prior. In the July 2008 issue of Neurology, researchers reported that “Exposure to the antiepileptic medicine Topamax in the first trimester of pregnancy carried a higher-than-usual rate of congenital malformations.”

In the study titled, “Topiramate in pregnancy — Preliminary experience from the UK Epilepsy and Pregnancy Register”, researchers found that 13 out of 178 patients taking Topamax gave birth to children with birth defects.

Manufacturers Plead Guilty

This bold move by the FDA comes after years of “issues” for the drug and its manufacturers. In 2009 two Johnson & Johnson subsidiaries, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc, were accused by the Department of Justice of promoting the drug “off-label” to physicians for unapproved purposes. According to the settlement, the manufacturers of the brand name version Topamax plead guilty and paid a $6.14 million criminal fine and $75.37 million for violating the False Claims Act.

Birth Defects Linked to Topamax

• Cleft Lip
• Cleft Palate
• Other Birth Defects

Do I Have a Topamax Lawsuit?

The Schmidt Firm, LLP is currently accepting Topamax birth defect claims in all 50 states. If you or somebody you know has taken Topamax during pregnancy and given birth to a child with Cleft Lip or Cleft Palate, you should contact our law firm immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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