March 10, 2014 — Good news for women who took the anti-seizure drug Topamax (topiramate) during pregnancy and had a baby with a birth defect — Law 360 reports that a Pennsylvania jury has awarded $3 million to the family of 5 year-old Payton Anderson, a boy who was born with cleft lip. His mother took Topamax during pregnancy to treat migraine headaches.
Lawyers allege that Johnson & Johnson failed to update the label on Topamax to reflect data showing that it could increase the risk of cleft lip and cleft palate. Lawyers allege that drug-makers knew as early as 2000 that babies exposed to Topamax during development had craniofacial birth defects.
It was the third time a jury in Philadelphia awarded damages in a Topamax lawsuit. In November 2013, $10 million was awarded to the family of Brayden Powell, who was born with cleft lip and other birth defects that will require multiple additional surgeries.
In October 2013, $4 million was awarded to the family of Blake Czimmer, a child who has multiple birth defects. These cases are currently on appeal. A fourth trial began in February 2014 on behalf of a 5-year old boy named Josiah Brown.
In March 2011, the U.S. Food and Drug Administration (FDA) published a Safety Communication to warn about a 16-fold increased risk of cleft lip and cleft palate from Topamax — approximately 1.4% of babies had oral clefts, compared to 0.07% in the general population.
The FDA urges doctors to use caution when prescribing Topamax to women of childbearing age. Oral clefts occur during the first trimester of pregnancy before most women know they are pregnant. They have also changed the pregnancy category on Topamax from a C to a D, meaning that there is positive evidence of fetal risk.
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