Recent studies have linked maternal valproic acid use during pregnancy to an increased risk for birth abnormalities and autism, including craniofacial, cardiovascular, and neurological anomalies. Valproic acid is the active ingredient in Depacon, Depakene, and Depakote.
The FDA approved valproic acid in 2008 for the treatment of epilepsy, which as of 2012, affected 50 million people worldwide, including over 2 million Americans. Valproic acid is also known as “divalproex sodium” or “valproate sodium” (about 1 in 26).
Since its first release, the FDA has published numerous warnings addressing the link between using Depacon during pregnancy and adverse fetal outcomes.
Although the importance of this medication is clearly demonstrated by its success in treating epilepsy, pregnant women should be advised to avoid using it because of its link to adverse fetal outcomes.
Information about Depacon
If Depacon is taken while pregnant, significant birth abnormalities may result. The FDA warned medical professionals and patients on December 3, 2009, that Depacon carries a higher risk of causing neural tube defects and other serious birth problems, including craniofacial defects, cardiovascular malformations, limb and skeletal defects, and cognitive defects.
Abbott Laboratories produces Depacon, also referred to as valproate sodium. Although the medicine was initially prescribed to treat seizures, it is now being used to treat other illnesses, including migraines and depressive disorders.
The fetus is affected by the medicine in the first trimester. Many women might not be aware of their pregnancy at this point, so medications that cause birth abnormalities in the first trimester are particularly problematic.
Side Effects of Depacon:
Birth Defects with Valproic Acid (Depacon, Depakene, and Depakote)
Valproic acid (Depacon) has been linked to craniofacial and cardiovascular congenital disabilities. Depacon, Depakene, and Depakote use by pregnant women are also linked to autism spectrum disorder.
The probability of having a baby with facial clefts or congenital heart problems was significantly increased by maternal use of antiepileptic medicines (AEDs) during pregnancy, according to a report published in Acta Neurologica Scandinavica in 1989 by a group of Scandinavian researchers led by ML Friis (CHD).
An excerpt from the article’s 1989 Acta Neurologica Scandinavica abstract reads as follows:
“Our findings imply that genetic variables have a very limited role in the etiology of facial clefts in children of epilepsy patients. Compared to background population values, children of epileptic mothers receiving AED had a 4.7-fold higher rate of facial clefts.”
According to the Mayo Clinic, craniofacial abnormalities include:
- A congenital disability, illness, or trauma that can result in facial or head deformities or craniofacial diseases.
- Abnormal skull morphologies (craniosynostosis), such as a forehead with one side flattened (plagiocephaly), a long and thin skull (scaphocephaly), or a pointy forehead, are caused by premature closure of joints called head sutures (trigonocephaly)
- Eyes that are unusually far apart are known as hypertelorism.
- Eyes that are unnaturally close together (known as hypotelorism).
A malformed skull, a small upper jaw, an unusual gap between the eyes, and fused fingers and toes characterize Apert syndrome.
Crouzon syndrome is characterized by bulging eyeballs, an abnormally shaped skull, and an underdeveloped upper jaw.
Face Clefts, Cleft lip, and Cleft Palate
Low cheekbone and lower jaw development are symptoms of Treacher-Collins syndrome.
Hemifacial microsomia is an asymmetry of one or both sides of the face, where the affected side’s bones are missing or undeveloped.
Depacon can also cause illnesses like neurofibromatosis or cancer.
Depacon, Depakene, and Depakote (valproic acid) with Cardiovascular Birth Defects
Heart abnormalities typically manifest in newborns when they are still in the womb. The heart starts to form a month after conception. Heart defects may develop at this stage, but certain illnesses, drugs, and genes could bring on heart abnormalities.
A team of researchers led by L. Etemad also concluded that:
“The incidence of major malformations in offspring of mothers with epilepsy who were treated with AEDs is higher than women with untreated epilepsy and in the general population.”
This is in addition to the 1989 article described above demonstrating the association between maternal use of Depacon/Depakene/Depakote during pregnancy and congenital malformation of the heart. Spina bifida, cleft palate, limb reduction deformities, heart abnormalities, hypospadias, and gastrointestinal atresia are some of these anomalies.
You may see the complete text of this second paper from the Journal of Research in Medical Sciences, which highlights the link between treating epilepsy and cardiovascular birth abnormalities, among other things.
Here is an example from the medical encyclopedia MedlinePlus, which is maintained by the National Library of Medicine and the National Institutes of Health and contains concise information on congenital cardiac malformation.
“Congenital heart disease (CHD) is a term used to describe a variety of cardiac conditions. The most typical kind of birth defect is this one. Compared to other birth defects, congenital heart disease is the leading cause of death in the first year of life.”
Cyanotic (blue skin color brought on by a lack of oxygen) and non-cyanotic congenital heart disease are frequently separated into two categories.
The most prevalent congenital cardiac conditions are covered in the lists below:
Cyanotic
- Ebstein’s oddity
- Left heart with hypoplasia
- Respiratory atresia
- Fallot Tetralogy
- Abnormal pulmonary venous return in its entirety
- Repositioning of the large vessels
- Atresia tricuspid
- Arteriosus Truncus
Non-cyanotic:
- Arterial stenosis
- Septal defect of the atria (ASD)
- Intracoronary canal (endocardial cushion defect)
- An aortic coarctation
- Arteriosus ductus patent (PDA)
- Stenosis of the lungs
- Defect in the ventricle septum (VSD)
These issues might appear separately or collectively. In most cases, congenital heart disease in children is the only birth abnormality present. However, chromosomal and genetic syndromes can include heart abnormalities. Some of these syndromes might be inherited from parents to children.
Examples include:
- DiGeorge Disorder
- Dwarf Syndrome
- Marfan disorder
- Thereon syndrome
- Turner syndrome
Investigations and studies into congenital cardiac disorders are ongoing. Some congenital cardiac issues can be caused by medications like retinoic acid for acne, chemicals, alcohol, and infections (like rubella) during pregnancy.
A high incidence of congenital cardiac abnormalities has also been connected to poorly managed blood sugar in pregnant diabetic mothers.
Symptoms
The disease determines the symptoms. Even though congenital heart disease is present from birth, symptoms may take some time to manifest.
Aortic coarctation is one defect that may not show symptoms for many years.
Other issues, including a little ventricular septal defect (VSD), might never result in any issues. Some persons with a VSD have regular lives and engage in normal levels of exercise.
Tests and Exams
During a pregnancy ultrasound, congenital cardiac abnormalities are typically discovered. When a flaw is discovered, a pediatric heart surgeon, other experts, and the baby can be born with the defect. For certain babies, having access to medical treatment at delivery might be the difference between life and death.
The infant will undergo various testing depending on the condition and the symptoms.
Treatment
The condition determines the treatment and how well the baby responds to it. Numerous flaws require close monitoring. While some will eventually recover, others will require medical attention.
Some congenital heart conditions can be managed solely with medicine. Others require one or more heart operations to be treated.
Speak with a Lawyer
If you or a loved one has developed significant health issues after using Depacon, consult a doctor immediately. You might also want to get in touch with a qualified class action lawyer who can assist you in defending your legal rights and recovering damages for your injuries.
