Birth Defect Lawyer Blog

Opioid painkillers such as codeine, oxycodone, and hydrocodone can be risky to take during pregnancy, according to a Centers for Disease Control and Prevention (CDC) study that was published in the American Journal of Obstetrics & Gynecology. Opioid medications include prescription drugs such as OxyContin, Vicodin and Tylenol-3.

The CDC study found that babies exposed to opioid drugs before or early on in the pregnancy were twice as likely to have hypoplastic left heart syndrome, a life-threatening condition where the left side of the heart is extremely underdeveloped. Infants with this serious heart defect often do not survive past one year; others must undergo expensive, invasive procedures and long hospital stays to save their lives. In many cases, even if the child survives, he or she requires lifelong medical treatment and is unable to lead a normal life.

Women who take opioid drugs during pregnancy are also more likely to deliver babies with other serious birth defects such as spina bifida, gastroschisis (an abdominal wall defect where the intestines protrude out of the body), hydrocephaly (abnormal fluid buildup in the brain), and congenital glaucoma.

The CDC study points out that the overall number of birth defects is relatively low. However, a woman who is pregnant or may become pregnant should discuss the risks with her doctor before using opioid pain relievers. "With very serious and life-threatening birth defects like hypoplastic left heart syndrome, the prevention of even a small number of cases is very important," said the study's lead author, Cheryl S. Broussard of the CDC's National Center on Birth Defects and Developmental Disabilities.

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A new study published in the February issue of Psychiatric Services found that the drug valproate is still commonly prescribed to women of childbearing age, despite evidence linking valproate with a higher risk of birth defects.

Valproate is an anticonvulsant drug commonly used to treat epilepsy, bipolar disorder and migraines. It is also known as Depakote, Depakene, valproate sodium and valproic acid. However, in 2009, the Food and Drug Administration issued a warning that fetuses exposed to valproate have an increased risk of neural tube defects, heart defects, skeletal and organ malfunctions, cleft palate, and fetal death. For example, spina bifida (a condition where the spinal canal does not close) is a severe birth defect associated with valproate use.

Findings released in December 2010 from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study showed that mental deficits were more frequent in children who were exposed to valproate. Prior NEAD research also found that 3-year-olds exposed to valproate in utero scored an average of 6-9 points less on IQ tests, compared to children exposed to other antidepressant medications.

The authors of the new study wrote, "Over 20% of childbearing-aged women receiving mood stabilizers were treated with valproate, although increasing data on the reproductive toxicity of this agent compel consideration of other non-antipsychotic mood stabilizers as first-line choices." The authors recommended that patients and health care providers be informed about the reproductive risks that come with taking mood stabilizers, and added that "reducing the rate of first-line valproate use among women of childbearing age creates an opportunity for prevention of reproductive toxicity."

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Recently, the Food and Drug Administration (FDA) issued stronger warnings about Topamax (topiramate), an antiepileptic drug that is linked to a higher risk of birth defects. New studies show that using Topamax during pregnancy can lead to a higher risk of birth defects like cleft lip and cleft palate, when the lip or palate does not fuse together properly. Information from the North American Antiepileptic Drug Pregnancy Registry showed that pregnant mothers who used topiramate were 20 times more likely to have babies with cleft lip or palate, compared to mothers who did not take epilepsy medications. The occurrence of cleft lip or palate was 3-4 times higher in babies who were exposed to Topamax, compared to other antiepileptic drugs.

The FDA advises that women who are or could become pregnant should be warned about the risks. "Alternative medications that have a lower risk of birth defects should be considered," said Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

The FDA will now classify Topamax as pregnancy category D (meaning there is evidence of human fetal risk, but using the drug might still be warranted in some cases). Previously, the drug was classified as Category C - studies on animals had shown a possible adverse effect on the fetus, but the potential benefits of the drug may outweigh the risk.

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