Spina Bifida - Consumer Justice Foundation

Spina Bifida

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Babies exposed to potentially defective medications in pregnancy may have a higher risk of developing birth defects like spina bifida. If you believe your child has been affected by a dangerous pharmaceutical drug, contact a birth defect attorney today.

Women struggling with severe nausea and vomiting during pregnancy, or medical conditions like epilepsy or major depressive disorder, may be prescribed pharmaceutical drugs like Zofran, Depakote, Topamax or Paxil during pregnancy. However, a growing body of research shows that these medications and others may cause devastating birth defects in babies exposed to the drugs in utero. If you took a prescription drug while pregnant and your child was born with spina bifida or another serious neural tube birth defect, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by dangerous medications, and can help put you in touch with an attorney who has experience handling spina bifida birth defect claims.

FDA, Spina Bifida and Drugs During Pregnancy

December 2005 – The FDA issues a press release warning patients and healthcare professionals that early results of new Paxil studies suggest that the antidepressant drug may increase the risk of birth defects when taken during the first three months of pregnancy.

July 2006 – A safety alert issued by the FDA indicates cites a case-control study finding that “infants born to mothers who took SSRIs after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”

October 2006 – The FDA adds a black box warning to the Depakote label, indicating that the drug may increase the risk of birth defects in babies.

December 2009 – The FDA warns about the potential risk of neural tube birth defects, heart malformations and craniofacial birth defects associated with Depakote use in pregnancy.

July 2011 – A warning from the FDA indicates that a child’s exposure to Depakote in utero may be linked to decreased cognitive functioning, including lower IQ scores.

March 2011 – The FDA issues a drug safety communication warning that Topamax may increase the risk of oral cleft birth defects in babies. The FDA also reclassifies Topamax as a pregnancy Category D medication.

Spina Bifida Birth Defect Studies

Guidelines from the American Academy of Neurology and the American Epilepsy Society indicate that pregnant women should avoid taking Depakote due to the risk of birth defects like spina bifida.

August 2006 – The journal Neurology publishes research finding that about 20.3% of women who took Depakote while pregnant experienced adverse pregnancy outcomes, compared to only 1% to 10.7% of women who took other, similar medications.

July 2008 – A study published in the medical journal Neurology indicates that babies born to mothers who took Topamax while pregnant experienced birth defects at 16 times the normal rate.

July 2009 – The Hebrew University’s Hadassah Medical School and the Israeli Ministry of Health report that exposure to Depakote in pregnancy may result in nearly three times as many birth defects in babies, including spina bifida.

June 2010 – Research published in the New England Journal of Medicine finds an increased risk of six different birth defects associated with Depakote use during the first trimester of pregnancy, including a 12-times increased risk of spina bifida.

August 2011 – The American Journal of Medical Genetics Part C publishes a special issue focusing on the study of birth defects and their causes, indicating that: about 40 infants with spina bifida could be born without the birth defect every year if Depakote wasn’t used during pregnancy, and about five infants with spina bifida could be born without the birth defect every year if Tegretol wasn’t used during pregnancy.

December 2014 – A study published in the American Journal of Obstetrics and Gynecology indicates that Zofran use during pregnancy may be linked to a 30% increased risk of major congenital malformations.

Why We Think Drug Manufacturers Should Be Held Liable for Spina Bifida Malformations

Spina bifida is a severe neural tube malformation that can have life-long consequences for children, and families with children who suffered spina bifida birth defects allegedly caused by exposure to a pharmaceutical drug are now filing lawsuits against the drug manufacturers, alleging that the companies:

  • Developed, marketed and sold a defective medication
  • Failed to conduct post-marketing studies regarding the risk of birth defects associated with their drugs
  • Failed to warn the public, the FDA and the medical community about the alleged risk of birth defects from their medications
  • Failed to disclose the results of important medical studies
  • Misrepresented the safety of their drugs, while downplaying the side effects
  • Failed to act responsibly and in the best interest of the public

What should you do? If your child has been diagnosed with spina bifida, you should contact a lawyer as soon as possible to discuss filing a birth defect lawsuit.

Spina bifida is a devastating birth defect, and the complications associated with spina bifida and other neural tube birth defects can persist throughout the child’s life. If you or a loved one has suffered from spina bifida and you believe a pharmaceutical drug to be the cause, consult an experienced product liability lawyer as soon as possible. You may have grounds to file a birth defect lawsuit against the drug manufacturing company, in order to pursue the financial compensation you deserve for your child’s injuries, past and future medical bills, and emotional trauma. With a qualified drug injury attorney on your side, you can also ensure that your rights are protected throughout the sometimes complicated legal process.

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