Michael C. Schafle Drug and Medical Device Litigation Law Blog on Lawyers.com

Is There Just Cause for Topamax Lawsuits?

Monday, January 23, 2012 by Michael C. Schafle

Photo of Michael C. Schafle

If you were taking the antiepileptic and migraine prevention drug Topamax while pregnant and your baby was born with a cleft birth defect, you may be entitled to Topamax lawsuits.

 

Read a magazine or newspaper and you see the sad face of a baby or toddler with a face deformity asking you the reader to send money to help fix it. If you think the cleft palate problem only happens in third world countries, you are mistaken. Cleft lip and cleft palate occur in about 1 or 2 of every 1,000 babies born in the United States each year, making it a common major birth defect.

 

In March 2011, the FDA announced a label change for Topamax, the anti seizure drug also prescribed to prevent migraine headaches. The label change notifies healthcare professionals about an increased risk for Topamax side effects for oral palate or cleft palate birth defects.

The North American Antiepileptic Drug Pregnancy Registry (NAAED) has shared data with the FDA showing an increased risk of cleft palates and cleft lips in infants exposed to Topamax during the first trimester of pregnancy. The United Kingdom’s pregnancy registry had similar data.

How widespread is Topamax use?

From January 2007 through December 2010, approximately 32.3 million Topamax prescriptions were written and approximately 4.3 million patients filled prescriptions from U.S. outpatient retail pharmacies.

There is definitely enough cause for Topamax lawsuits.

 
Posted at 15:46 PM
Topic: Drug and Medical Device Litigation
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