In 2012, a Zofran recall was issued to remove the 32 mg single-dose intravenous version of the drug from the market after it was linked with an increased risk of torsades de pointes, a potentially fatal heart arrhythmia. Zofran lawsuits have been filed alleging drug maker GlaxoSmithKline failed to disclose risks of birth defects, including cleft lip, cleft palate, and heart defects, as well as other complications related to the drug’s use by pregnant women, and also that the drug maker promoted Zofran for uses not approved by the U.S. Food and Drug Administration (FDA).
If you or a loved one took Zofran and suffered severe complications, or took Zofran while pregnant and delivered a child with birth defects, including cleft lip, cleft palate, or heart defects, contact Attorney Group to learn more about your options. We can answer your questions, and your call is free and without any obligation. If you have a case, we can connect you with an affiliated Zofran attorney who can assist you in seeking compensation.
Zofran Linked to Risk of Heart Complications, Birth Defects
The December 2012 Zofran recall was not the first acknowledgement of potential risks of Zofran use. A study that examined 900,000 pregnant women from 1997 to 2010 suggested an overall increased risk of birth defects in women who took Zofran by 30 percent. A 2006 report from the FDA recognized heart complications among known adverse reactions.
In June 2012, the FDA released a drug safety communication to warn physicians of the dangers of using the 32 mg IV of Zofran due to the risk of a deadly arrhythmia. The doses included in the Zofran recall were pulled from the U.S. market in early 2013, but other doses of oral and IV Zofran are still available for use in chemotherapy patients.
Other heart-related risks linked to Zofran use, particularly during the first trimester of pregnancy, include heart defects such as atrial septal defect, ventricular septal defect, and heart murmurs.
Contact Us For More Information
Contact Attorney Group today if you or a loved one took Zofran and suffered severe complications, or if you took the drug while pregnant and delivered a child with birth defects, including cleft lip, cleft palate, and heart defects. We can answer your questions at no out-of-pocket cost to you and if you have a case, we can connect you with an affiliated Zofran attorney who can assist you with throughout the legal process.