Front side of Alamo in downtown San Antonio TexasThe Dallas Texas city skyline at night

Does Depakote Cause Birth Defects?

Sponsored Links

Depakote is an oral and intravenous applied medication that is commonly used to treat patients with seizures as well as certain psychiatric conditions. Over the past few years, some studies have made a link between Depakote and birth defects. Depakote is an anticonvulsant medication and a mood stabilizer that helps treat patients with bipolar and seizure disorders.  It is known as valproic acid, and Depakote’s form is coated to help administer the drug more effectively. Most patients take Depakote by mouth (orally) and it is often taken with food because the drug is known to upset a person’s stomach.  Dosage for Depakote is based on a patient’ age, weight, medical condition and how they respond to the drug therapy.  Physicians recommend that the medication be taken at the same time of day every day to keep the levels of Depakote in the blood consistent.

What Conditions Does Depakote Treat?

depakote 250mg 500mg bipolar

Oral Depakote is used to treat a variety of conditions, but the most common are:

  • Manic Depression
  • Petit Mal Seizures
  • Convulsive Seizures
  • Epileptic Seizures
  • Migraine Prevention
  • Bi-Polar Disorder
  • Rapid Cycle Manic Depression
  • Simple Partial Seizures

Depakote is available in capsule form, extended release, sprinkles and other oral solutions.  The type of Depakote a patient is prescribed is based on their condition and their capacity to take their medication.

depakote

When treating bipolar disorders, Depakote is often paired with other selective serotonin re-uptake- inhibitors or SSRIs to treat the patient more efficiently.

When Depakote was originally created, it was considered a medical breakthrough for its time.  There were little to no medications back in the day for manic depression or individuals suffering from bipolar disorder.  Compared to lithium, patients had better success rates and responded better to Depakote, making it the miracle drug for psychiatric centers.

Depakote is also used to help lessen the severity of migraines and reduce their occurrences.  Patients that suffer from severe headaches reported relief taking Depakote.  Only patients with two to three weekly migraines were given Depakote as part of their treatment plan.

Side Effects Associated With Depakote

depakote cleft palate birth defect

There are some documented side effects listed on the manufacturer’s website as well as the handouts given to patients.  Common side effects were nausea, drowsiness, diarrhea, abdominal pain, vomiting, tremors, tiredness, and hair loss.  These side effects can be mild to moderate — depending on the dosage the individual is taking and their sensitivity to the drug.

There are some serious side effects associated with this drug as well. According to the manufacturer, there are reports of serious liver damage that could result in death — especially if it is not detected early on.  Children younger than age two who take Depakote are more likely to develop serious liver failure.  Liver damage was reported within the first six months of starting the drug and the symptoms include dark urine, pain in the right side of the abdomen, nausea or vomiting, swelling of the face, yellowing of the skin or eyes, and loss of appetite.

Another serious side effect associated with Depakote is pancreatic inflammation that could become life threatening if medical attention is not sought after right away.

Does Depakote Cause Birth Defects?

is depakote tied to birth defects

 

The list of possible side effects is hard enough on patients, but also there is a significant risk to pregnant women taking the drug.  Fetuses are at high risk for birth defects according to multiple studies; therefore, the drug is not recommended for pregnant women.  According to some studies, pregnant women who take Depakote during their pregnancy, even for a short period of time, are at more risk for having babies with:

  • Spina Bifida
  • Neural tube defects
  • Extra fingers or toes
  • Heart defects
  • Malformed limbs
  • Malformed brain or skull
  • Cleft palate
  • Lowered intelligence or IQ

According to a 2004 study, women who took Depakote during their pregnancy were more likely to have fetuses with birth defects than women who took alternative drugs.  Also, deaths, defects and developmental delays occurred in 28 percent of women taking the medication.  According to Depakote.com, it is estimated that one or two out of 100 babies whose mothers took Depakote will be born with birth defects.

Because Depakote is a valproic acid, it carries a significant risk to pregnant women.  Also, when compared to other anti-seizure medications, Depakote and other valproic acid-based medications increased the risk for birth defects.

Women who are on Depakote and become pregnant should be changed to a different medication or type of therapy.  Women who are thinking of becoming pregnant are urged to change medications as well because of the high risk for birth defects in this medication.

Lawsuits and Litigation

depakote-drug-birth-defects-infographic

Over the past few years, Abbott Laboratories has been receiving numerous fines because of their production of Depakote.  In 2012, the company was ordered by the courts to pay $1.6 billion because of their illegal marketing of this prescription medication. During that four-year investigation, the Justice Department found several FDA violations, violations of state and federal law, etc.  The company was cited for promoting off-label uses of the drug — meaning uses that were not approved by the FDA.  In fact, Abbott Laboratories made claims that the drug could be used to treat illnesses like

depression, schizophrenia, and anxiety — none of which was validated by the FDA before they had made their advertisements.

Also, in July of 2012, 27 women filed suit against the company in Illinois.  All of the women had taken the prescription medication to help with migraines and epilepsy symptoms and had done so during the early portions of their pregnancy.  All of these women had children born with Depakote related birth defects.

Is Depakote Available Today?

Depakote-Birth-Defect-Attorney cleft palate

Depakote is still being prescribed today, despite the side effects and risk of birth defects.  It is, however, offered under different names, which can include:

  • Depakene
  • Depakote ER
  • Stavzor
  • Valproate

Patients who are prescribed this medication should be tested for pregnancy before administering the drug.  Women should also be given ample warnings about the risks if they are to become pregnant while taking the medication.  It is the responsibility of the physician to test and educate their patients thoroughly before prescribing, but there are adequate warnings on the drug label and information packet given to patients at the pharmacy as well.

Even though it has significant side effects and tragic birth defects, the drug is still one of the more effective medications for epileptics and individuals suffering from bipolar disorder.

Below is a video where the FDA is reminding healthcare professionals and patients about an increased risk of birth defects in infants whose mothers took Depakote during pregnancy. Patients who used Depakote and gave birth to a child with spina bifida, anencephaly or other neural tube defects may be eligible to file a lawsuit. Good luck!

Thank you for visiting Tex.org.

Sponsored Links