Zofran Linked to Cleft Palate, Heart Problems, and Other Birth Defects in Newborns

Pregnant women may suffer severe morning sickness, making them unable to provide their developing babies with the nutrients they need. Many of these women have turned to anti-nausea medications to get through the first months of pregnancy, but one medication has come under fire for causing life-altering birth defects in the infants they carried. If you or your child has suffered as a result of taking Zofran, our dangerous drugs law firm can help. Contact us today to learn how to pursue a case against the drug manufacturer and get justice for your family.

Zofran Effects Include Debilitating Injuries to Infants

Medical research indicates a significant increase in birth defects in the infants of women taking Zofran, also known as ondansetron, while pregnant. The powerful anti-nausea medication is often prescribed during the first trimester of pregnancy, when nausea symptoms are most severe. However, this is also a vital stage for the infant, and the medication can interfere with normal development of the baby’s brain and body.

Zofran has been linked to many different birth defects in newborns, including:

  • Heart defects. Some children have been born with atrial and ventricular septal defects, commonly known as “holes in the heart.”
  • Mouth deformities. Zofran may prevent a child’s mouth from taking proper shape in the womb, resulting in cleft lip or cleft palate.
  • Kidney and liver defects. Children who have suffered liver damage may be born with a yellowing or discoloration of the skin and eyes (jaundice), while other infants can suffer kidney problems.
  • Foot abnormalities. Improper development of the legs and feet can cause turned-in feet, bowlegs, clubfoot, and unusual positioning and alignment of the feet that can prohibit walking.
  • Skull deformities. The bones in a baby’s head may not fuse properly, causing skull abnormalities that can affect the child’s vision and mental or emotional development.
  • Infant death. Intestinal or musculoskeletal abnormalities may be so severe they are fatal for the newborn.

Patients Sue GlaxoSmithKline for Zofran Injuries and Unethical Marketing Practices

Many patients are surprised to learn that Zofran was never meant to be prescribed to pregnant women. Zofran was approved by the FDA in 1991 to treat nausea in cancer patients who would often suffer loss of appetite and vomiting as a result of chemotherapy treatments. When doctors began to prescribe Zofran as an “off-label” remedy for morning sickness, drugmaker GlaxoSmithKline encouraged the practice, even marketing the drug to pregnant women.

However, the FDA never approved Zofran for use by pregnant women, and GlaxoSmithKline never received approval from the FDA to market the drug as a morning sickness remedy. The FDA has not recalled Zofran, but has issued warnings about potential side effects for pregnant patients, and has recommended that doctors inform pregnant women of Zofran’s potential risks to infants before prescribing it.

In 2012, GlaxoSmithKline was ordered to pay $3 billion in legal settlements after pleading guilty to federal charges of fraud. The case included allegations of illegally promoting several of the company’s medications, including Zofran. According to court documents, the drugmaker had been aware of the risks of harm to developing infants for over a decade, but continued to market the drug to pregnant women.

We Can Help You Get Justice for Zofran Injuries to Your Baby

If your unborn baby suffered serious injuries as a result of Zofran, we can help you get compensation for your hospital costs, lost time from work, future medical care, permanent disabilities, and pain and suffering. The McGartland Law Firm has won millions of dollars in settlements and verdicts for victims who have been injured as a result of corporate greed and negligence. Best of all, we work on a contingency-fee basis, so you will owe us no legal fees unless we win your case.

We work tirelessly to obtain favorable outcomes for all of our clients, and can guide you through the legal process while you take the time you need to recover with your child. Call the number on this page today to speak with one of our representatives about your case.