Zofran during pregnancy found to double the risk of cleft palate defects
Data from the National Birth Defects Prevention Study shows Zofran causes a 237% risk of birth defect cleft palate. If you or a loved one used Zofran during pregnancy, and your child experienced a birth defect, contact a lawyer at Levin Simes Abrams regarding a Zofran cleft palate lawsuit.
Up to 80% of women experience nausea and vomiting during pregnancy, nearly 16% of which take medication to help control these symptoms. Seeing an opportunity to profit, GlaxoSmithKline, the manufacturer of Zofran (Ondanestron), heavily promoted the off-label usage of Zofran to pregnant women experiencing nausea and vomiting even though such use was never approved by the FDA.
Zofran studied for causing Cleft Palate
Due to the prevalence of Zofran (Ondanestron) as an off-label agent used to control nausea and vomiting, researchers at the Center for Birth Defects Research and Prevention at the Massachusetts Department of Public Health, Harvard School of Public Health, Slone Epidemiology Center at Boston University, and the National Center on Birth Defects and Development Disabilities determined it was important to study and evaluate the safety of such treatment during pregnancy. Specifically, the study assessed the risk for birth defects among infants born to women using Zofran or other medication during pregnancy, as opposed to those born to women who did not take Zofran.
The researchers took data from the National Birth Defects Prevention Study, a multi-site population based case-control study, and examined each pregnancy for the rate of common birth defects such as cleft lip, cleft palate, neural tube defects, and others. The study looked at subjects with expected delivery dates between September 24, 1997 and December 31, 2004.
The results demonstrating the dangers of Zofran pregnancies were clear: Zofran usage during the first trimester was associated with a 237% risk for cleft palate birth defects, a statistically significant result that was not seen in any other medication tested for cleft palate. Women who used Zofran during pregnancy gave birth to children with cleft palate birth defects at more than double the rate.
These risks were studied against the underlying rate of women who also had nausea and vomiting but did not take Zofran. The women who did not take Zofran did not experience an increase in birth defects in their children, eliminating the possibility that the underlying symptoms were to blame for the difference. Zofran increased the risks of these defects, as it had similarly increased the risk of congenital heart defects.
GlaxoSmithKline, the manufacturer of Zofran, profited from years of promoting off-label usage to treating nausea during pregnancy, and put thousands of pregnant women and their infants at risk. Despite these astonishingly high risks for birth defects, to this day, GlaxoSmithKline has never provided warnings to these women or their prescribing doctors. These risks thus remain largely hidden from pregnant women today.
How We Can Help You and Your Loved Ones
If you or a loved one used Zofran during pregnancy, and your child experienced a structural heart or cleft palate birth defect, contact a lawyer at Levin Simes Abrams for a free consultation. Contact us using the form on this page, by calling us at 1-888-426-4156 (24 hours a day), or by emailing us at [email protected].
Learn More about Cleft Palate Birth Defects Caused by Zofran Pregnancy
What is Cleft Palate?
Cleft Palate is a form of congenital deformity caused when there is abnormal facial development during gestation. “Cleft” refers to a gap, and in the case of a “cleft palate” birth defect, the infant is born with a gapbetween the two plates of the skull that form the roof of the mouth. In an infant born to a Zofran pregnancy, this hard palate is not completely joined and results in a disjoining of both the hard palate and the soft palate. When there is a deformity of the palate, it is typical to see a corresponding defect in the lip (cleft lip).
The uvula, or soft palate, is typically split in instances of cleft palate of the hard palate. This means that the connective tissue in the mouth is split along with the hard skull palate, resulting in a visible hole or split in the roof of infant’s mouth. This results in a cleft or hole creating a direct connection between the nasal cavity and the mouth.
What are the Symptoms of a Cleft Palate Birth Defect?
Besides the visible effects of a cleft palate separating both the hard palate and soft palate, a cleft palate can also result in air leaks into the nasal canal, nasal emissions while talking, and speech errors due to poor articulation. These are conditions that occur from the connection of the nasal cavity to the mouth known as “velopharyngeal inadequacy” (VPI).
If left untreated with surgery, clefts of the hard or soft palate can result in poor social development of children. Children with untreated cleft palates can experience reduced self-esteem, poor behavior, and underdeveloped social skills. These psychological effects are sometimes seen to be greater in girls than boys.
In addition to psychological effects, a cleft palate can also result in symptoms including:
Reduction in language learning
A child with a cleft palate can have difficulty feeding and require use of a special harness or gravity assisted feeding techniques. The opening of the mouth to the nasal cavity can also produce an increase in ear infections, which can also result in a permanent loss of hearing. Due to the difference in how sounds occur within the skull of a child with a cleft palate, children can also experience difficulty learning language and speaking normally.
What are the Treatments for Cleft Palate Caused by a Zofran Pregnancy?
Surgical treatment for cleft palate depends on the severity of the cleft. Sometimes care can be a lifelong process. Treatment via surgery can involve multiple stages to correct defects.
The first step is typically surgical intervention to close the main cleft gap, performed at 6-12 months of age. This surgery will repair the cleft and in a quarter of cases is the only surgery required.
For the remainder of cases, additional surgical intervention must occur to continue to reduce the effects of the cleft palate, such as continued abnormal or hypernasal speech, or surgery to correct the jaw. Additional operations to correct hearing loss caused by velopharyngeal inadequacy include the placement of a tube into the eardrum. Depending on the severity of the condition and the affected portions of the cranial skull and soft tissue, surgery can occur anywhere from 0 months to young adulthood.
This chart lists the typical date range of surgeries for cleft palate:
What is a Cleft Lip Birth Defect?
Cleft lip is a separation of the upper lip, this can occur with or without a cleft palate. Typically treatment includes surgery several months after birth to close the lip. The surgery is typically performed at 10 weeks and after the child has reached 10 pounds.
If the child has a bilateral cleft, it may require two separate surgeries to address each cleft.
What is an Unilateral or Bilateral Cleft?
A unilateral cleft lip or palate involves one side, a bilateral involves both sides. See these images to see the difference between a unilateral complete cleft and bilateral complete cleft. Cleft palate and cleft lip defects can occur at the same time.