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.
READ MORE DEPAKOTE BIRTH DEFECT LEGAL NEWS
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.