The Manchin Injury Law Group in West Virginia is currently pursuing cases involving birth defects after a mother has used Zofran during her first trimester of pregnancy. Multiple studies have linked Zofran to a heightened risk of birth defects including heart defects, cleft lip and cleft palate.
If you or a loved one has been affected by ingesting Zofran, call the Manchin Injury Law Group today at (304) 367-1862 for a free consultation with a lawyer.
A common prescription medication provided to mothers during pregnancy is Zofran. Manufactured by GlaxoSmithKline, Zofran is a medication used to treat nausea and is given as an off-label use to expecting mothers to treat morning sickness. Unfortunately, Zofran may cause serious birth defects such as oral clefts and heart malformations.
Originally approved by the FDA in 1991 as an injectable form, Zofran was first used as treatment of chemotherapy-induced nausea and vomiting. In 1995, oral doses of Zofran were approved for vomiting and nausea in post-operative patients.
Numerous studies indicate that Zofran can cause birth defects. In a 2014 study, it was reported that Zofran posed an increased risk “for a cardiovascular defect and notably cardiac septum defect” in infants whose mother had taken the medication during pregnancy. A 2012 study found that children were twice as likely to have disorders such as cleft palate and cleft lip if their mothers had taken Zofran during the pregnancy.
The use of Zofran for pregnant women was not approved by the FDA, and Zofran was actually listed as a Pregnancy Category B drug. This means that there was never sufficient information regarding the drug’s safety to indicate that the drug could be used in pregnant woman. Regardless of this, the manufacturer of Zofran off-label marketed the drug for use in pregnant women. These marketing practices were investigated by the Department of Justice, which resulted in a $3 billion settlement due to the illegal nature of the marketing practices used by the manufacturer.
The Manchin Injury Law Group in Fairmont, West Virginia, is currently pursuing cases involving birth defects following a mother’s use of Zofran in the first trimester. If you or a loved one knows of a child with birth defects following prenatal exposure to Zofran, contact the Manchin Injury Law Group today at (304) 367-1862 or email us here for a free consultation to see if your case meets our qualifying criteria.