Tegretol Spina Bifida Lawsuit Results in Settlement by Wal-Mart

Walmart is seeking compensation from a drug manufacturer, after it agreed to settle a birth defect lawsuit brought by a couple whose son was born with spina bifida after exposure to Tegretol during pregnancy.

The company indicated on Monday that it has reached a settlement for an undisclosed amount in a claim brought by Paul and Jean Pendino, who alleged that Walmart failed to warn them about the risk of Tegretol birth defects.

Walmart indicates that it did not warn the couple because the manufacturers of the epilepsy drug, PDX and Landmark Data, did not include a warning for pregnant women in the materials provided to Walmart, according to a report by Courthouse News Service.

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Landmark Data is now known as the National Health Information Network.

According to Walmart, the only warning regarding pregnancy that came with the Tegretol was that it may decrease the effectiveness of birth control. Walmart is now pursuing compensation for what it paid to the Pendinos from the drug companies.

Previous studies have indicated that side effects of Tegretol increase the risk of spina bifida, which is a developmental malformation involving the spinal cord, where some vertebrae are not fully formed.  The condition may allow portions of the spinal cord to protrude through the opening in the bones, leading to serious life-long injuries for the child

According to a 2010 study published in the British Medical Journal (BMJ), use of Tegretol (carbamazepine) during pregnancy was associated with 2.6 times the risk of giving birth to a child with spina bifida, compared to women who did not take the drug. Overall, 3.3% of women who took the drug gave birth to a child with spina bifida.

Tegretol was first approved in the U.S. in 1974 as an anticonvulsant. It is approved for the treatment of epilepsy, trigeminal neuralgia and bipolar disorder.


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