Epilepsy Drugs Linked to Increased Fetal Risks

Dangerous drug lawyers at Pintas & Mullins Law Firm report that anti-epileptic drugs (AEDs) are now linked to several other risks beyond those listed on the drugs’ labels. According to a new study, fetuses exposed to AEDs while in utero had increased risks of preterm birth, below average head size, and lower birth weights than those born to mothers who did not take AEDs during pregnancy.

Currently, the FDA lists an array of potential side effects for AEDs such as suicidal thoughts and behavior. The following is list of AEDs included in the FDA’s analyses and academic fetal studies: Carbatrol, Equetro, Tegretol, Depakote, Felbatol, Neurontin, Lamictal, Keppra, Trileptal, Lyrica, Gabitrill, Topamax, and Zonegran.

In 2011, the FDA updated Topamax’s labels specifically to indicate the risk of oral clefts in children born to mothers taking the drug. In that year new data was released showing this increased risk, and the FDA highlighted that oral clefts (lip and/or palate) develop in fetuses during the first trimester of pregnancy, before many women even know they are pregnant. Due to these findings Topamax was classified as a Pregnancy Category D drug, which indicates that there is positive evidence of human fetal risk based on scientific data.

Popular AED drug Tegratrol is also classified as a Pregnancy Category D drug. Its labels mention the possibility of craniofacial defects, hypospadias, cardiovascular defects, and various other malformations of bodily systems. Additionally, the FDA linked Valproate to lower IQ scores in exposed children, and has a Pregnancy Category X designation (meaning the risks clearly outweigh the benefits).

A recent study conducted in Denmark, at the Aarhus University Hospital, analyzed data from about one million pregnancies between 1997 and 2009 in Denmark. Researchers identified nearly 3,000 mothers who took an AED while pregnant.

Researchers then adjusted for a variety of confounders (including age, income, smoking status, drug abuse), and found a small list of negative birth outcomes that were significantly more common among these AED-exposed infants, compared to those whose mothers did not take an AED. Those adverse birth outcomes were: low birth weight (lower by 31.96 grams), lower gestation age (by 0.92 days) and smaller head circumference (by .07 cm).

Additionally, relative risk for preterm birth (born before 37 weeks of gestation) was higher, as was the risk of being undersized for gestational age. These findings mirror similar results in animal AED studies, which were mostly conducted on pregnant laboratory rats exposed to AEDs. Those rodents exposed to the drugs in utero were born significantly smaller than the control rodents.

The Danish research group also collected data on fetal death rates but has yet to analyze and publish their findings. Neurologists in the United States stated that this study illuminated the difficult decisions mothers and physicians have to make between treating epilepsy and the best interest of the child. Unfortunately, much of this risk-balance remains unknown and unstudied, and most pregnant epileptic women choose to continue AED treatment because they fear uncontrolled seizures will be more damaging. The neurologist interviewed for a MedPage Today article was unaware of any research centering on the outcomes and risks of pregnancies during which epileptic mothers are not pharmaceutically treated.

In related news, Depakote manufacturer Abbott Labs was recently accused to racketeering when it spearheaded efforts to market the epilepsy drug for unapproved uses. In 2012, Abbott paid $1.6 billion to settle a lawsuit which claimed it marketed Depakote to treat bipolar mania and migraines, which was not approved by the FDA. The settlement concluded a four-year investigation into Abbott’s shady business practices.

Depakote lawyers at Pintas & Mullins Law Firm are currently reviewing and investigating cases of severe birth injuries associated with AEDs and other pharmaceuticals, such as anti-depressants. If your child suffered a birth malformation or defect from exposure to an AED in utero, you have important legal rights, and may be entitled to significant compensation for your medical bills, lost wages, and emotional distress. Our attorneys have decades of experience in this field, and offer free, no-obligation consultations.