What has the FDA done to warn consumers about Depakote?
In 2006, the FDA ordered that a black-box warning be included on the packaging of Depakote to warn pregnant women about the elevated risk of serious birth defects that may be caused by the drug. The FDA’s inclusion of the black-box warning was prompted by a study that found that around 20% of pregnant women taking Depakote gave birth to babies with birth defects.
Since a black-box warning was added to Depakote’s packaging, the FDA has issued four other statements warnings about the drug’s connection to other birth defects, including neural tube defects, heart defects, decreased cognitive function, and autism.
If you believe there is a connection between your child’s medical condition and Depakote, you should consult with an attorney at Williams Kherkher about what legal action you may now be eligible to pursue. To speak with an attorney about your case, please call our office at (888) 220-0640 today.