Reasons for Prescribing Depakote Could be a Factor in Lawsuits


. By Heidi Turner

As with many medications, there could be a variety of reasons for prescribing Depakote. Although Depakote is mainly used and approved as an anti-seizure medication, it can be prescribed off-label to treat migraines. The problem is that the risk of Depakote side effects experienced by the infant, including a reported risk of Depakote birth defects, could far outweigh the benefits of treating a migraine, making the reason for prescribing Depakote a factor in lawsuits.

One of the issues a doctor and patient must take into account when determining which medicines to prescribe is whether the benefits outweigh the risks. What this means is that the benefits achieved by taking a certain medicine must be greater than the side effects experienced. For example, a medication to treat mild nausea should not carry a high risk of heart attacks—the risk of heart attack is disproportionate to the risks associated with mild nausea.

Similarly, the condition the medicine is prescribed to treat should be of greater possible consequence if left untreated than any potential side effects. For example, antidepressants may be prescribed because the risk of serious consequences associated with having untreated depression is considered far greater than the potential side effects associated with the antidepressants.

Where complications come into play is when the risks could affect an unborn child. When a pregnant mother takes a medication, there is a risk the child could wind up experiencing side effects, including birth defects, developmental delays and heart problems. In cases of developmental delays, the side effects might not be recognized until well after the child is born.

When the medication is prescribed to a pregnant woman to treat a serious condition that could have life-threatening consequences for both the mother and fetus—such as in the case of women with epilepsy—the risks are generally seen as worthwhile because the medication could be saving the mother's and baby's life. But Depakote is also sometimes prescribed to treat migraines, which may not be worthy of the risks.

And there are reportedly serious potential risks for the unborn baby exposed to Depakote. According to some reports, the risk to the infant includes a risk of spina bifida, neural tube defects, and other birth defects.

Depakote is classed in FDA pregnancy category D, due to the potential for life-threatening birth defects. On October 2, 2012, Abbott Laboratories, maker of Depakote, was ordered to pay $500 million in fines, plus forfeiting almost $200 million more in relation to its marketing of Depakote for off-label uses. Those uses included treating schizophrenia and behavioral disturbances in patients with dementia.


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