Posted by & filed under Pharmaceutical/Medical Devices.

Zofran is a drug produced and sold by Glaxo Smith Kline (GSK) solely for the purpose of nausea relief in chemotherapy patients.  The U.S. Food and Drug Administration approved Zofran for this purpose.  However, GSK marketed the drug for “off label” use, meaning that they marketed the drug for purposes other than treating chemotherapy patients.  One of the targets of this unapproved marketing was to treatment morning sickness and hyperemesis gravidarum (nausea, vomiting, and weight loss) in pregnant women.  GSK marketed the drug as safe for pregnant women without ever performing any clinical trials to insure the drug was safe.  More than one million women took Zofran each year.  Unfortunately, Zofran is a drug that goes through the placenta and can harm the fetus.  GSK new 2 since 199that Zofran passed through the placenta to the baby but chose not to perform any clinical trials to see whether the drug was safe or not.  It now appears that Zofran causes birth defects including: heart defects (atrial septal defects, heart murmurs, and ventricular septal defects); cleft lip; and cleft palate.  There is also concern now that the drug may not be safe for the pregnant women themselves.

Litigation is now pending against GSK for their flagrant negligence in failing to test the drug which led to birth defects in children.  If you or a loved one took Zofran and have suffered and injury, please call Mike at 913-789-7477 to request a free consultation.