Findings from the North American Antiepileptic Drug (AED) Pregnancy Registry have confirmed that prenatal exposure to the popular epilepsy drug phenobarbital increases the risk of birth defects in children born to mothers who took the drug during pregnancy. Phenobarbital has been found to reduce levels of folic acid in the body, a condition which is highly associated with birth defects, especially neural tube defects. The phenobarbital lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits nationwide on behalf of babies born with phenobarbital birth defects.

Phenobarbital Birth Defects Lawsuit Review: If you or somebody you know has a child that has been diagnosed with a birth defect related to phenobarbital, you should contact our lawyers immediately. Consultations are always free. Please use our confidential email contact form or call toll free 24 hrs/day by dialing (866) 588-0600.

What’s the problem with phenobarbital?

It has been well established in the medical literature that anticonvulsant drugs like phenobarbital are known to have a significant impact on levels of folic acid in the body, especially through their effect of reducing folic acid absorption. This is of particular concern to women who are pregnant or may become pregnant. Because of its effect on folic acid levels, phenobarbital and related drugs are known to cause a high degree of risk for birth defects, specifically neural tube defects. Folic acid deficiency itself is highly correlated with neural tube defects, making the combination of these two factors extraordinarily risky for women of child-bearing age who are using phenobarbital.

In addition to the risk of birth defects, phenobarbital may also cause addiction or withdrawal symptoms in a newborn if the mother takes the drug during pregnancy. Taking these facts into consideration, most physicians caution against prescribing phenobarbital to pregnant women.

Archives of Neurology Study on Phenobarbital Birth Defects

A report published in the Archives of Neurology found that among 77 pregnant women who were treated with phenobarbital, five (6.5%) delivered a baby with a serious congenital birth defect. When compared with the rate in the general population of approximately 1.62%, there was more than a four-fold increase of major malformations in infants exposed to phenobarbital it utero.

“Phenobarbital had been on the market since 1912 and many doctors assumed it was safe,” Dr. Lewis B. Holmes from the Genetics & Teratology Unit at Massachusetts General Hospital told Reuters Health. “Within the past 10 years several studies suggested that exposure to phenobarbital posed a serious risk. The AED Pregnancy Registry…confirmed this high risk.”

Phenobarbital & Neural Tube Birth Defects (NTDs)

NTDs are serious birth defects with symptoms that range from mild to severe impairment. These abnormalities are typically caused by incomplete development of the brain, spinal cord and/or their protective covering. This occurs when the fetus’ spine fails to close properly during the first trimester of pregnancy. Some of the most common neural tube defects associated with phenobarbital include:

  • Spina Bifida: A rare but extremely serious congenital neural tube defect characterized by the failure of the backbone and spinal cord to close before birth. The term spina bifida comes from Latin and literally means “split” or “open” spine. The condition typically occurs in the first trimester of pregnancy, when the two sides of the embryo’s spine fail to join together.
  • Anencephaly: Anencephaly is one of the most common neural tube defects reported around the country, occurring in approximately one out of every 10,000 births. The defect manifests itself early in the development (typically within the first eight weeks) of an unborn child, and results when the upper part of the neural tube fails to close. Infants with anencephaly are born lacking a forebrain (the front part of the brain) and a cerebrum (the thinking and coordinating part of the brain). The remaining brain tissue is often exposed and not covered by bone or skin. Babies born with this defect are typically blind, deaf, unconscious, and unable to feel pain. Although some affected individuals may possess a rudimentary brain stem, the lack of a functioning cerebrum effectively eliminates the possibility that the child will ever gain consciousness.
  • Encephaloceles: This type of defect results in abnormal openings in the skull though which the brain tissue protrudes. Encephaloceles are often accompanied by deformities of the skull or face and/or other brain malformations. Symptoms may include hydrocephalus (fluid on the brain), spastic quadriplegia (paralysis of all four limbs), developmental delays, vision problems, mental and growth retardation and seizures. The prognosis for babies born with encephaloceles varies depending on what brain tissue is involved and the accompanying brain malformations and symptoms. While most babies with this condition do not survive or are severely retarded, early surgery has helped some children.

Phenobarbital Overview

Phenobarbital is an FDA-approved barbiturate medication typically prescribed to control seizures, relieve anxiety, and to prevent withdrawal symptoms in people who are addicted to other barbiturates. First marketed as Luminal by Friedr. Bayer et comp., phenobarbital is the most commonly used anticonvulsant in the world. It also has sedative and hypnotic properties but, as with other barbiturates, has been suspended by the benzodiazepines for these uses. Phenobarbital is listed as a core medicine in the World Health Organization (WHO) Model List of Essential Medicines, which is a list of minimum medical needs for a basic healthcare system.

Phenobarbital is used in the treatment of all types of seizures except absence seizures. It is no less effective at seizure control than more recently-developed drugs such as phenytoin and carbmazepine, but it is typically less well tolerated. The first line of treatment for status epilepticus are fast acting benzodiazepines such as lorazepam or diazepam. If these fail, phenobarbital may be used as an alternative. Phenobarbital is the first line choice for the treatment of neonatal seizures, and is sometimes indicated for alcohol and benzodiazepine detoxification for its sedative and anticonvulsant properties.

If you are taking phenobarbital during pregnancy

If you taking phenobarbital and are pregnant or planning to become pregnant, the Mayo Clinic recommends that you should take at least 0.4 mg (400 mcg) of folic acid daily to prevent birth defects. If your doctor thinks you are at especially high risk, a much larger dose of folic acid – 4 mg (4000 mcg) per day – may be recommended.

Be sure to talk to your doctor at length about the potential side effects of phenobarbital if you are pregnant or planning to become pregnant. Taking one or more seizure medications may significantly increase the risk of birth defects, so physicians sometimes gradually reduce the number or amount of seizure drugs taken by women planning for pregnancy. However, this is not always done because it increases the risk of seizures, which can injure both the mother and the baby. You should never stop taking phenobarbital or reduce the dosage without your doctor’s consent.

Is there a time limit in filing a phenobarbital birth defects lawsuit?

Although we encourage all our potential clients to take great care in selecting their phenobarbital birth defects lawyer, it is important that you understand that time is of the essence. The applicable statute of limitations in your state may time bar your claim. Furthermore, we are unable to provide you with legal advice without first evaluating your potential case. Accordingly, please take the time now to contact us by using the confidential email contact form below or by calling us toll free 24 hrs/day by dialing (866) 588-0600.

We hope we will be able to assist you with your potential phenobarbital birth defects lawsuit and look forward to speaking with you.


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