Birth Defects Due to Medication—What Parents Need to Know

According to the CDC, about 1 in 33 babies—approximately 120,000—are born in the U.S. with some form of birth defect. These conditions, ranging from mild to severe, are usually discovered within the first year of life. Most congenital disabilities begin within the first three months of development in the womb. According to the Cleveland Clinic, there are many different causes, including “genetics, infection, radiation, or drug exposure, or there might be no known reason.”

In March 2022, CNN reported that Metformin, a commonly prescribed drug for treating Type 2 Diabetes, had been linked to an increased risk of birth defects. Research conducted in Denmark between 1997 and 2016, published in the Annals of Internal Medicine, found a 40% higher risk of congenital birth defects in male babies when men took Metformin within three months prior to conception (the time it takes for fertilizing sperm to mature). Though there are still several unknown factors, in an editorial, Germain Buck Louis, a reproductive and perinatal epidemiologist at George Mason University, argued that “Clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal Metformin use relative to other medications.”

However, in the U.S., there are no FDA warnings about Metformin for men who plan to father children.

In an earlier case, beginning in 2015, global pharmaceutical giant GlaxoSmithKline faced hundreds of lawsuits after women who had taken Zofran (ondansetron) gave birth to infants with a host of complications, including cleft palate, skull deformities, and heart defects. The lawsuits allege that GSK actively marketed off-label use of the drug to expectant mothers and knowingly misrepresented its safety for the developing fetus. Zofran is an effective anti-nausea drug used to help cancer patients suffering side effects from chemotherapy and other treatments. Eventually, doctors began widely prescribing it for mothers-to-be experiencing morning sickness or hyperemesis gravidarum, a rare condition that causes severe nausea and vomiting in pregnancy. Despite a lack of FDA approval for those purposes, Zofran prescriptions for pregnant women increased from 50,000 monthly in 2008 to 110,000 by the end of 2013.

Perhaps the most notorious and tragic case of a widely prescribed medication causing congenital disabilities dates back to the 1950s and 60s when Thalidomide, prescribed for nausea during pregnancy, resulted in thousands of children worldwide being born with severe deformities, including shortened and missing limbs. Initially hailed as a “wonder drug,” one dose of this “harmless” pill was enough to cause tremendous harm to a fetus.

If you are pregnant, it’s essential to be aware that numerous medications intended to help you can have harmful effects on a developing fetus.

• Anticonvulsants may increase the risk of cleft lip/palate and organ abnormalities.
• Opioids can cause heart and neural tube (brain, spine, spinal cord) defects, gastroschisis (abdominal defect), feeding problems, low birth weight, and miscarriage.
• Exposure to certain chemotherapy drugs can increase the risk of miscarriage, especially if administered in the first 12 weeks of pregnancy, various congenital malformations.
• Accutane (isotretinoin), a medication used to treat acne, is known to cause birth defects, including deformities of the heart, brain, and face if taken during pregnancy.
• Though the risk is considered low and the evidence is somewhat conflicting, certain SSRI antidepressants have been linked to heart/brain/organ defects and skull abnormalities.

Sometimes medication is necessary during pregnancy. It’s vital to discuss the risks and benefits with your health care provider.

In 2015, the FDA updated its drug labeling system to give health care providers clear, evidence-based information on the benefits and risks of each medication for “Pregnancy, Lactation, and Females and Males of Reproductive Potential,” which they can discuss with their patients and use as a guideline in prescribing.

If you believe a prescribed medication you or your partner took harmed your infant, you may wonder what recourse you have. If your doctor did not exercise the proper standard of care in prescribing the medication, or if the drug company or pharmacy failed to provide adequate warning about the risks, you may be entitled to compensation. Recovering for damages can help cover your child’s future medical expenses (procedures, medication, equipment, rehabilitation, etc.), pain and suffering, and even lost earning potential.

Medical malpractice cases are very complex; it's not easy to prove that negligence or doctor error contributed to the development of a birth defect, and that it's not more likely due to other factors (genetic, disease, environmental, etc.). It’s vital to speak with an experienced attorney in congenital disability cases. When a birth injury occurs, it causes significant and long-term harm to a child or mother. The family often has the legal right to seek compensation for medical expenses, monetary losses, and pain and suffering. To learn more about birth injuries and your legal rights, please contact the qualified and caring medical malpractice attorneys at Aitken * Aitken * Cohn to learn more.