Zofran is a drug manufactured by GlaxoSmithKline Inc. (“GSK”). GSK lists 4 uses for Zofran on its self-produced Information. ONLY THESE FOUR USES BELOW WERE APPROVED by the U.S. Food and Drug Administration:
The roof of the mouth (palate) is formed between the sixth and ninth weeks of pregnancy. A cleft palate is when the tissue of the palate does not completely join together.
These include heart murmurs and atrial septal defects also commonly known as a hole in the heart.
If you took Zofran and your child was born with any significant defect we encourage you to contact us and see if taking Zofran may have been a factor.
Janet, Jenner & Suggs, LLC will handle your case and will reach out to you. For more than 30 years, the attorneys of Janet, Jenner & Suggs, LLC have helped uncover the truth about medical, hospital and doctor errors; dangerous drugs and defective medical products; workplace and environmental hazards; and unsafe products. We have gone beyond the courtroom to help provide more legal rights for injured people.
The FDA did not approve Zofran for use by pregnant women. This did not prevent the manufacturer, GlaxoSmithKline (GSK), from encouraging OBGYNs and doctors to prescribe the drug to pregnant women to alleviate morning sickness. GSK has admitted that Zofran (also known by its generic name, Ondansetron) was not tested for use by pregnant mothers, and states the following in its Prescribing Information:
“Reproduction studies have been performed in pregnant rats and rabbits with daily oral doses up to 15 and 30 mg/kg/day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predicative of human response, this drug should be used during pregnancy only if clearly needed.”