As the number of lawsuits filed against GlaxoSmithKline continues to swell, plaintiffs have reported that another study has reported data that may show there is an increased risk of birth defects in a child who was born to a mother who took Zofran during her pregnancy.
The study, performed by BioMed Research International, reviewed the birth records of 96,968 children. They compared the records of children whose mothers took Zofran during pregnancy to those whose mothers did not. Researchers concluded that the records showed that there was an increased risk of a stillbirth occurring and a 20% increased risk for a major birth defect when the mother took Zofran during the first trimester.
This isn’t the first study to come to these conclusions – in the hundreds of lawsuits currently filed regarding Zofran, nearly all of them reference the Danielsson, Pasternak, and Andersen studies.
The complaints filed against GSK all allege that the company knew, or should have known, that women who took the drug during pregnancy would have an increased risk of birth defects in their unborn child. Mothers are alleging that their children have been forced to undergo surgical procedures and physical therapy that they otherwise wouldn’t have had to endure, because the company lead the public to believe that the drug was safe for use during pregnancy.
The drug does carry the approval of the U.S. Food and Drug Administration, however, not for the treatment of morning sickness. The FDA determined that the drug was safe for patients who experience nausea and vomiting after anesthesia, radiation, and chemotherapy. Clinical trials in humans were not performed on expectant mothers, and so the department did not approve the drug for use during pregnancy.
In October of 2015, the Judicial Panel on Multidistrict LItigation consolidated Zofran lawsuits into MDL 2657. The consolidation transfers cases to the U.S. District Court District of Massachusetts where they will be overseen by the Honorable Judge F. Dennis Saylor. Both the plaintiffs and defendant were happy with this decision, as it will most likely save everyone involved time and money.
Name: Michael Monheit
Source URL: http://www.prreach.com/pr/21907
Release ID: 101355