Zofran, a popular morning sickness and nausea drug was approved in 1991 by the U.S. Food and Drug Administration to treat nausea and vomiting in chemotherapy, radiation and surgery patients. It works by affecting serotonin levels in the brain which interrupts the messages sent from the brain to the rest of the body. Zofran has been on the market for more than 20 years but the medication has never been approved for the treatment of morning sickness in pregnant women. 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 zofran birth defect rates have been increased.
Recent studies indicate that it also comes with serious Zofran side effects to both mother and infant. Recently a woman from New York filed a lawsuit against GlaxoSmithKline (GSK) alleging that GlaxoSmithKline’s anti-nausea drug Zofran caused severe birth defects. As per the mother she was prescribed generic version of Zofran during her first and second trimesters of pregnancy to treat morning sickness. The fetal development in the initial stage of pregnancy is very delicate. As a result exposure to Zofran in pregnancy, the woman’s baby daughter was born with a cleft palate and a cleft lip.
Cleft palate and cleft lip
Cleft palate is a facial and oral malformation, is a gap in the roof of the mouth. Normally, the tissues that make up the lip and palate fuse together in the second and third months of pregnancy, while the baby is developing inside the mother. A cleft palate is an opening of the hard palate (the bony front portion of the roof of the mouth) or the soft palate (the muscular non-bony region in the rear of the roof of the mouth. Clefting results when there is not enough tissue in the mouth or lip area, and the tissue that is available does not join together properly. A cleft lip contains an opening in the upper lip that may extend into the nose as well as gums. This can affect one side of the mouth (unilateral) or both sides (bilateral), and can be complete (meaning the cleft goes up into the nose) or incomplete.
There are several U.S families who are suffering from the severe Birth defect cause by Zofran. It is illegal for physician to prescribe an off label medication for unapproved uses. As of last month more than 300 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. The recent lawsuit of New York plaintiff joins more than 300 other families’ lawsuits that were waiting for their day in court with the healthcare giant. The litigation will likely take time to reach the inside of a courtroom, but plaintiffs in the litigation are in it for the long haul as long as they get their chance to hold the company accountable.
Already GlaxoSmithKline has been fined $3bn in criminal and civil penalties to settle Department of Justice allegations that the company had promoted Zofran for off-label use in pregnant women and had bribed physicians and encouraging the prescription of unsuitable antidepressants to children. It also alleged that GlaxoSmithKline was paying kickbacks to doctors who prescribed Zofran. Despite all accuses and allegations GSK claims the drug is safe and tried its best to Fight off Fraud Charges in the Zofran lawsuit. If you took Zofran during your pregnancy and your baby was born with a heart defect, club foot, or cleft lip or palate, Contact Drugsclaim.com for free case review. We have an experience attorneys group who evaluate your case free of cost unless we win the case.