In recent years, several studies have surfaced warning that the use of Zofran during pregnancy may increase the risk of birth defects, as a result Zofran side-effect lawsuit claims continue to assert that use of the drug during pregnancy causes congenital birth defects. More than 270 Zofran lawsuits are pending in the U.S. District Court; District of Massachusetts alleging Zofran medication during Pregnancy to treat morning sickness can lead to newborns having cleft palate, cardiac malformations and kidney malfunctions. As per a register based nationwide cohort study, Ondansetron medications have adverse effects on the fetus during early pregnancy which causes “Congenital Malformations”.
A recent Zofran lawsuit was filed on behalf of a mother from Hainesport, New Jersey, who gave birth to a girl child suffered severe injuries multiple life-threatening birth defects allegedly due to prenatal exposure to the drug. According to the lawsuit the mother was prescribed Zofran in her first trimester of pregnancy to treat morning sickness and migraine headaches .The lady gave birth to her daughter on May 13, 2007 with congenital heart defects. As per the court documents her daughter referred as B.B diagnosed with numerous congenital deformities together with a pair of heart defects and dysmorphic facial features. According to the complaint, the family had no previous history of birth defects and genetic screenings has failed to detect any genetic abnormalities. The lawsuit clearly outlines the devastating effects that Zofran allegedly have on pregnant women and their children.
As per the report B.B mother says her daughter was born with a low birth weight along with severe abnormalities like atrial and ventricular septal defects (hole in the heart). According to a court document, B.B was born with craniofacial abnormalities included a recessed chin, high palate, low set ears and small jaw. As per the mother statement B.B palms are crossed by a single crease, rather than three. She was also born with Hydronephrosis, a condition usually caused by a blockage in the urinary tract or something disrupting the normal workings of the urinary tract. The lawsuit also claims clinodactyly, a congenital malformation of Curving of the fifth finger toward the fourth finger, sometimes called “fifth finger clinodactyly”.
Zofran was approved in 1991 by the U.S. Food and Drug Administration to treat nausea and vomiting in chemotherapy, radiation and surgery patients. The medication has never been approved for the treatment of morning sickness in pregnant women. The lawsuit claims that GlaxoSmithKline knew that its representations of the drug were false because its effects have never even been studied for morning sickness in expectant mothers or their developing babies. The drug therefore has been given an FDA rating of “Pregnancy Category B.”. The drug has been prescribed to pregnant women suffering from morning sickness by the physicians without FDA approval, which is considered as “off-label. As a result birth defect rates due to Zofran have been increased.
According to a survey till late February 2016, there were 223 cases assigned into the MDL, including 12 new cases filed since mid-January. Plaintiffs are claiming that GlaxoSmithKline was aware of the life threatening danger that Zofran could pose to a developing fetus and to a new born but they were flop to warn physicians and patients about the risks associated with the drug. The Allegations on manufacturer covers that they failed to warn patients as well as doctors, when it was not FDA approved for pregnancy, they declined to evaluate data and safety information, and advertising the drug as a safe treatment for pregnant women. When Physicians feel the drug can treat their patients health they can legally prescribe medication for off-label purposes. However, pharmaceutical companies are not legally allowed to market drugs for unapproved purposes and without proper clinical testing.