Although significant public awareness has been raised about the risks and dangers of using Zofran during pregnancy, many doctors and physicians keep prescribing this medication to treat morning sickness. Nobody ever contested the superior effectiveness or power to stop nausea and vomiting of the famous antiemetic drug. What’s really concerning, however, is the discomforting amount of birth defects that are associated with the use of this medication.

Giving birth to a malformed baby is a tragic misfortune. Some of these malformations can harm a newborn or even compromise his entire life, such as those suffered by the twin sons of Taci, a mother who has been prescribed with this medication during the first trimester of pregnancy. Taci, like many other pregnant mothers, had to endure the often unbearable weight of working with nausea and morning sickness. She asked three different doctors for a solution, and all three of them suggested ondansetron to treat her condition. Doctors kept saying that the drug was safe and effective and that she would feel immediately better after taking it. Even worse than that, she was prescribed the antiemetic drug by specialists as well, and even in the hospital when she went to urgent care.

Taci explained that GlaxoSmithKline (GSK), the pharmaceutical company that manufactures Zofran, influenced the health care providers to prescribe this medication as an off-label treatment for nausea and vomiting during pregnancy (NVP). She claims to be mad at GSK but she’s also angry with the doctors because of their carelessness. They woman said that they should know well about the terrible risk of fetal malformations and explained how no physician ever warned her about ondansetron being an off-label medication. She found strange that insurance didn’t cover the 4 mg pills she was initially prescribed. However, they still allowed a nurse to administer her injections once a week for the whole duration of her pregnancy: 33 weeks.

The effects of these injections were tremendous, however. When the two twins were born, they suffered from several birth defects. Taci required an emergency C-section, and both the two babies needed urgent neonatal care to survive. The male twin required resuscitation at birth and has been later diagnosed with chronic lung disease and kidney nephrosis. He also suffers from hearing and vision impairment, and both the two babies eventually developed autism as they grew up. Taci had a second pregnancy, but she never took ondansetron again. Her other daughter is perfectly healthy.

Just like Taci, many mothers who took this medication during pregnancy gave birth to babies with congenital malformations. A large number of Zofran lawsuits have been filed in which plaintiffs accuse GSK of fraudulently marketing an unsafe off-label medication. Taci had to quit her job to look after her son, following him through the hardships of speech therapy, physical therapy and the hospital treatment required for his malformations. She had to recourse for the help of a specialized attorney to ask GSK for compensation because her husband’s health insurance does not cover all the expenses needed for her son’s special education.

Article written by: Dr. Claudio Butticè, Pharm.D.
Published: 2016/07/27