Depakote, Depakene, and Depacon are often prescribed for bipolar disorder, epilepsy, and sometimes migraine headaches. The common active ingredient in these four drugs is valproic acid, or valproate.
These drugs have been shown to cause significant fetal birth defects when taken by pregnant women, especially during the first trimester of pregnancy.
Here is a list of the possible fetal side effects of these drugs, according to the FDA Drug Labels:
- Major congenital malformations, particularly neural tube defects (e.g., spina bifida)
- Decreased IQ scores following in utero exposure
- Increased rates of other major congenital malformations, such as craniofacial and cardiovascular defects:
- cleft palate
- heart defects (such as atrial septal defect)
- polydactyly (multiple fingers or toes)
- craniosynostosis (premature closure of sutures in skull)
- hypospadias (abnormal location of urethra in males)
Given the potential life-altering side effects of these drugs, it is important for doctors to ensure that they are prescribing the drug appropriately.
If prescribing one of these drugs to a woman of “childbearing age,” the doctor needs to ensure the following:
- the drug is absolutely essential to the management of the patient’s condition; and,
- no other drugs would provide adequate management or treatment of the patient’s condition.
Concerning the first point, the FDA drug labels provide the following warning:
Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate.
In regard to the second point, the drug labels provide this second warning:
Valproate should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable.
If the doctor failed to ensure the aforementioned criteria were met, then Depakote, Depakene, or Depacon may have been improperly prescribed.
Such improper prescription could potentially serve as the basis of a medical malpractice lawsuit against the prescribing doctor if it resulted in the birth of a child with one of the aforementioned detrimental side effects.
Another key element to consider when prescribing Depakote, Depakene, or Depacon to women of childbearing age will be discussed in my next post.
In the meantime, visit our website to learn more about the issue of proper prescription concerning these drugs.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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