Cleft palate defect doubles with Zofran drug.

Another anti-nausea morning sickness drug in trouble? Thalidomide* all over again? Cleft palate causation is elusive, complex., and multifactorial. Thus, it’s news when a single factor seems to have this much of an impact.



Cleft palate condition doubles with Zofran.


Cleft palate child.

Cleft palate child.


Here’s a recent press release that bears on cleft palate etiology:

” reports on concerning results of several studies which appear to link Zofran exposure to fetuses through their mothers to the development of congenital birth defects in those fetuses. The drug, now a subject of increasing controversy, was developed by corporate giant GlaxoSmithKline, and then, in an especially controversial move, was marketed “off-label” by the company to pregnant women across the nation for a use which the drug was never FDA-approved to treat.

Zofran is an anti-nausea drug which was given approval by the United States Food and Drug Administration (FDA) specifically to treat patients suffering from nausea and vomiting episodes after undergoing chemotherapy, radiation, or anesthesia. After the manufacturer was given this approval, however, GlaxoSmithKline also began to market their drug as a morning sickness treatment, both to Ob/Gyn offices across the nation and to the general public. Plaintiffs currently involved in lawsuits surrounding the drug call that marketing tactic “reckless and negligent”, as the drug had never been tested for safety on pregnant women and their unborn babies, and had never been given FDA approval for this use.

Because of this “off-label” marketing, Zofran was prescribed “off-label” to an estimated 1 million women in just one year’s time. Today, the anti-nausea drug has become the topic of a surge of lawsuits from parents across the nation who all similarly allege that by taking the medication while pregnant, they caused their their growing babies to develop a range of severe, and sometimes fatal, congenital birth defects. Defects most commonly mentioned in Zofran lawsuits are cleft lip and palate, kidney defects, clubfoot, transposition of the greater vessels, tetralogy of fallot, atrial septal defect and ventricular septal defect, and respiratory distress.

Plaintiffs involved in Zofran birth defect lawsuits have gained support from several concerning studies. In 2012, a study highlighted a twofold increase in the likelihood of cleft palate development for fetuses exposed to Zofran while in utero. Another notable study, published in 2014, found that Zofran exposure appeared to cause a 30% overall increased risk for the development of congenital malformations in growing fetuses.

The continually growing Zofran lawsuits were recently consolidated by the U.S. Judicial Panel on Multidistrict Litigation to form MDL No. 2657. The cases involved are being overseen by Judge F. Dennis Saylor IV in Boston, Massachusetts. As they await additional trial preparations, the attorneys of Monheit Law are helping to ensure that anyone who used Zofran while pregnant, and who subsequently gave birth to a child with defects, will be provided with the important opportunity to investigate their legal rights in full. These mothers, families, and children may be entitled to legal action and substantial compensation. Currently, Monheit Law is offering free legal consultations to qualified individuals, in order to help them seek justice.”

To find more info, visit this website.  


*Thalidomide sold under the brand names Immunoprin, among others, is an immunomodulatory drug and the prototype of the thalidomide class of drugs. Today, thalidomide is used mainly as a treatment of certain cancers (multiple myeloma) and of a complication of leprosy.

Thalidomide was first marketed in 1957 in West Germany under the trade-name Contergan. The German drug company Chemie Grünenthal developed and sold the drug. Primarily prescribed as a sedative or hypnotic, thalidomide also claimed to cure “anxiety, insomnia, gastritis, and tension”.[3] Afterwards, it was used againstnausea and to alleviate morning sickness in pregnant women. Thalidomide became an over-the-counter drug in West Germany on October 1, 1957. Shortly after the drug was sold in West Germany, between 5,000 and 7,000 infants were born with phocomelia (malformation of the limbs). Only 40% of these children survived.[4]Throughout the world, about 10,000 cases were reported of infants with phocomelia due to thalidomide; only 50% of the 10,000 survived. Those subjected to thalidomide while in the womb experienced limb deficiencies in a way that the long limbs either were not developed or presented themselves as stumps. Other effects included deformed eyes and hearts, deformed alimentary and urinary tracts, blindness and deafness.[5] The negative effects of thalidomide led to the development of more structured drug regulations and control over drug use and development.[6]

For the rest of this Wiki article, go here.


To learn about CLEFT HEART: Chasing Normal, click the Amazon or Barnes & Noble buttons in the margins. Or click the image of the book cover. My coming-of-age memoir has intertwining love stories, mystery, tragedy, and triumph.

Speak Your Mind


CommentLuv badge

This site uses Akismet to reduce spam. Learn how your comment data is processed.