Cleft Palate Caused by Depakote use During Pregnancy

One of the major birth defects often connected with the drug Depakote® is cleft palate. This congenital birth defect occurs when the roof of a baby's mouth does not completely develop and fuse before the baby is born, resulting in an opening of the palate called a cleft. The cleft can form in the hard palate located at the front of the mouth or in the uvula, the small flap that descends from the soft palate. In some cases, this cleft can even reach as far back as the baby's nasal cavity or include a gap in the jaw.

The first months of pregnancy are critical for an embryo's development. Very important development occurs during this time, including the shaping of the head. There are five tissue lobes that grow and facilitate this formation. Failure of these lobes to fuse together can result in cleft palate, among other developmental defects.

Several key studies have looked into the link between Depakote® and birth defects, including a study that was published in The New England Journal of Medicine in June of 2010. These researchers analyzed data and concluded that certain birth defects, including cleft palate, were more common among women who took Depakote® during the first three months of their pregnancy than in those who did not.

Due to the severe birth defects associated with Depakote®, the FDA has now cautioned women about taking this drug during pregnancy.  Many people are of the opinion that even these recent warnings are inadequate to convey the true risk of birth defects such as cleft palate.  Despite the congenital birth defects, such as cleft palate, which can result from a pregnant woman taking Depakote ®, Abbott Laboratories, Inc. has still failed to require pregnancy tests and mandatory birth control for women of child bearing age who are taking the drug.