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Zofran Potential Side Effects: Cleft Palate

Zofran, a popular “off label” remedy for the symptoms of morning sickness, has now been linked to an increased risk of major birth defects. Amid allegations that GlaxoSmithKline, Zofran’s manufacturer, unlawfully promoted the drug for unapproved use during pregnancy, families have begun to file Zofran birth defect lawsuits.

While this litigation is currently closed, learn more about a Zofran Potential Side Effects: Heart Defects from our team of attorneys.

Litigation Status: Inactive
Accepting Clients: No
Content Author: Laurence Banville
Edited By: Emily Smith
Published: 0707/2727/15151515
Fact checked on: 0707/2727/15151515
"The lawyers that form this alliance truly work on these cases and often take leadership positions on the steering committees that litigate them." - Laurence Banville

Does Zofran Cause Cleft Palate?

In 2012, researchers from Harvard Medical School and Boston University’s Slone Epidemiology Center found that women prescribed Zofran’s active ingredient during the first trimester were 2.37 times more likely to deliver children with a cleft palate. In a study funded by the US Centers for Disease Control & Prevention, the team reviewed more than 10,000 birth and prescription records to arrive at their conclusion.

Several other studies have linked Zofran to an increased risk for congenital heart defects.

Have Any Zofran Birth Defect Lawsuits Named Cleft Palate?


While a majority of the currently-filed Zofran lawsuits cite congenital heart defects, one claim has been brought in relation to a child who was born with cleft palate.

The claim was filed on April 3, 2015, in the US District Court for the District of Montana, Billings Division. Filing her complaint under case number 1:15-cv-00026-SPW-CSO, a mother says that she was prescribed Zofran as an “off label” morning sickness treatment early in her first trimester. Her daughter, named as M.M. in court documents, was born in 1998, Plaintiff writes, and immediately diagnosed with both a cleft lip and palate. According to court documents, M.M. “has been forced to undergo ten surgeries within her first sixteen years of life.”

Another lawsuit, filed in the US District Court for the Eastern District of Arkansas, Western Division, claims that prenatal exposure to Zofran caused an unborn child to develop a cleft lip. The claim was filed on May 21, 2015, under case number 4:15-cv-00284-BRW.

What Is Cleft Palate?

During healthy fetal development, facial tissues grow from either side of the skull, eventually meeting in the middle to form smooth, continuous surfaces and the facial features generally considered “normal.” Between six and eleven weeks of pregnancy, a similar process occurs inside a child’s mouth: tissues grow from opposite sides and meet in the center to create the roof of a child’s mouth, the palate.

But if these tissues are inhibited for some reason, and don’t close in the middle, children can be born with a cleft palate, a split or opening in the roof of the mouth.

Children can also be born with a cleft lip, in which the upper lip is split or separated by a “cleft.” If a child is born with a cleft palate, but no cleft in their lip, the condition is known as an “isolated cleft palate.”

Together, the conditions of cleft palate and cleft lip are referred to as “orofacial clefts.” Many parents prefer the term “orofacial differences” because it doesn’t imply that a cleft lip or palate is a “defect,” something that is wrong with a child, but simply another feature that makes them unique.

How Common Is It?

According to the US Centers for Disease Control, around 2,650 US babies are born with a cleft palate each year. In other words, 1 out of every 1,510 children born in America will be born with a cleft palate.

Girls are 2 times more likely to be born with isolated cleft palate than boys.

Does It Hurt?

No. Babies born with orofacial clefts do not feel pain associated with the condition.

With that being said, a cleft palate can severely impact a child’s ability to feed, speak and hear.


Without a smooth surface to form the roof of their oral cavity, babies with cleft palate are unable to create the vacuum required to draw milk fully into their mouths. As a result, feeding is often difficult. Many children need specialized feeding devices, along with treatment from nutritionists and speech therapists with expertise in swallowing problems.

Children who cannot be properly nourished may even suffer from “failure to thrive,” a condition marked by insufficient weight gain that may lead to impaired cognitive and physical development. In developed countries with robust health care systems, this complication is rare.


Breathing can also be difficult, as air is channeled through the cleft and out through the nose, rather than passing down the windpipe. After preliminary repairs, respiration generally returns to a healthy level. In some cases, oral appliances are required to “block” the cleft.

Speech, Language & Hearing

Speech problems are a common obstacle faced by children born with a cleft palate. Children and young adults may seem to have an abnormally “nasal” voice, since much of the air used to create words and sentences escapes upward through the cleft and out through the nasal passages. This is called velopharyngeal insufficiency

At an earlier stage of development, a cleft palate can impede the very process of language acquisition, in which a child learns to speak by mimicking the sounds made by others. Accurately echoing the sounds they hear around them can be hard. In addition, many common speech sounds are created by pressing the tongue against the palate; a large split in the roof of the mouth can make this action difficult.

In babies born without a cleft, the palate acts as a barrier between the mouth and nasal passages. With a cleft palate, fluids can enter these passages and then pass upward into the sinuses, where they eventually meet tubes leading to the ear. As a result, children with cleft palate often suffer from chronic middle ear infections, or chronic otitis media, and permanent hearing loss may be a result.


The cleft in a lip often continues down, creating another cleft or groove in a child’s upper gums. This abnormality can affect the way teeth grow and proper jaw alignment, requiring specialized dental surgeries or prosthetics. Dental problems are rare, but not unheard of, in children born with an isolated cleft palate.


As a society, we are becoming more accepting of those who look and speak differently, but children born with orofacial clefts may still face social traumas at school.

What Treatment is Available?

Every orofacial cleft is unique, and treatments will vary widely depending on the cleft’s size and severity. But in most cases, a “team” approach, in which children are treated by multiple specialists rather than a single general practitioner, is the standard of care.

Initial surgical procedures are required to close a cleft palate; the first generally occurs between 9 and 12 months after a child’s birth. In a procedure called palatoplasty, surgeons connect the muscles across the cleft and then rearrange other tissues to close the split. At the same time, “ear tubes” (or “grommets”) may be inserted to properly ventilate the Eustachian tube, which connects the middle ear to a cavity directly above the palate.

As the face develops, and structures mature, further procedures may be required to adapt to these changes. In one repair, a bone graft is applied to create a level gum line for the growth of permanent teeth. Some children will require a number of surgeries, extending even into their teenage years.

As we’ve seen, orofacial clefts can impact far more than just a child’s facial structure. Since hearing, speech and breathing can all be impaired, many parents seek out a craniofacial team, a diverse array of specialists, including:

  • Dieticians and nutritionists – evaluate whether or not a child is being adequately nourished
  • Otolaryngologist (ENT) – an “Ear, Nose & Throat” doctor to assess hearing problems
  • Speech-language pathologists – assist children in overcoming difficulties with speech and swallowing
  •  Oral surgeons and orthodontists – evaluate and direct proper jaw and tooth development
  • Audiologists – specialize in treating hearing difficulties
  • Social workers and psychologists – to support both parents and child in tackling stress and social pressures

What Are The Causes?

Congenital abnormalities of any nature are extremely difficult to explain. In isolated cases, the precise causes of a child’s birth defect will likely never be known. With that being said, the health community has identified two potential areas of research that are almost certainly at the root of the vast majority of congenital anomalies: genetics and environmental factors.

Abnormalities in genetic information are undoubtedly involved in many birth defects. Genes control the development, form, and function of every physical structure in the human body, and researchers are certain that many congenital conditions are caused by genetic mutations.

Environment, on the other hand, refers to the substances that a mother ingests or comes into contact. Many chemicals are known to have teratogenic properties: they can affect fetal development in adverse ways. In fact, some common pharmaceutical products are able to pass from a mother’s bloodstream into the tissues of her unborn child; some cause birth defects.

At least as early as 2006, researchers had demonstrated that Zofran’s active ingredient ondansetron is able to “cross the placental barrier,” entering fetal tissues via the placenta. In a study conducted in Hong Kong, researchers administered ondansetron to 41 women prior to a voluntary termination of their pregnancies during the first trimester. Analyzing samples of fetal tissue, the team found high concentrations of ondansetron “present in all embryonic compartments.” As we’ve seen, researchers have now linked Zofran to an increased risk of cleft palate.


Joined by a multi-state coalition of experienced attorneys, Banville Law has begun to investigate potential claims involving Zofran and birth defects. Current Plaintiffs say GlaxoSmithKline has been concealing mounting evidence of the drug’s association to major birth defects, including cleft palate, for more than two decades.

If that allegation is true, any woman who was prescribed Zofran to treat morning sickness and then delivered a child with cleft palate may be eligible to bring a claim against the company.

Learning more about your legal options is free. To speak with one of our Zofran attorneys today, call or fill out our online contact form.

Continue Reading:  Zofran News

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