The Unborn Child Cannot Comment on Depakote Birth Defects

Washington, DCThe capacity for a drug—any drug—to be allowed on the market without being completely safe appears to defy logic on the surface. However, the US Food and Drug Administration (FDA) has long since followed the protocol that so long as a drug's benefits outweigh the risks, it is worthy to be sold and used according to the various cautions. Depakote is one such drug.

An anticonvulsant prescribed to treat bipolar disorder, epilepsy and other manic disorders, Depakote carries various risks for the patient. However, assuming the patient is apprised of the various issues inherent with Depakote side effects and can weigh the potential of adverse reaction against the benefit of having some control over bipolar or epileptic symptoms, the decision to take the good with the bad can be surprisingly easy in the face of serious symptoms.

It's when someone for whom that decision is made suffers needlessly that the real tragedy of Depakote emerges.

Depakote birth defects, as a descriptor unto itself, is at once tragic and somewhat disconnected. It's when the reality of such birth defects is brought to the fore that the true gravity of valproate semisodium's dark side is revealed.

Cleft palate. Malformations of the hand. Spina Bifida. The appearance of many a Depakote lawsuit suggests that such birth defects can, and do, happen—with many parents claiming that they were not aware of such concerns that the drug is dangerous.

The FDA, for its part, has bowed to such a suggestion and moved Depakote to a more serious pregnancy classification. Various studies have suggested that pregnant women who take anticonvulsants such as Depakote during pregnancy stand a 20 percent chance of delivering a child with a birth defect.

That child is a human being having had no say in what drugs his mother may have been taking. He had no influence as to whether the FDA observance of benefits outweighing risk may or may not have made sense for him.

Can the Depakote birth defects be corrected? Can the parents or the parent's HMO afford corrective surgery? Or will a child be made to go through life with a cleft palate or malformed hand? How many parents will be made to suffer the heartache of seeing their child ridiculed at school or go through life with limited opportunity due to the ingestion of Depakote during pregnancy?

Manufacturers warn that Depakote should not be taken during pregnancy. However, such a caution is useful only when a pregnancy is planned or suspected. Many women are not aware they are pregnant until several weeks in—perhaps as long as the first trimester. By then, potential damage to an unborn child by a mother-to-be taking Depakote may already be irreversible.

Diseases such as bipolar disorder and epilepsy are not to be derided or taken lightly. Medication to help control symptoms can mean the difference between contributing as a functioning member of society and being held hostage.

For the Depakote patient, the FDA credo of acceptable risk outweighed by tangible benefit may seem a reasonable choice. However, such a choice could put an unborn child at the precipice of a lifetime of restriction and compromise.