Pregnant Women Are Particularly At Risk
The anti-nausea medication Zofran can reduce nausea and vomiting in patients undergoing chemotherapy and certain other medical procedures. Unfortunately, the drug can have severe side effects, especially when taken by pregnant women. Some women taking Zofran during pregnancy gave birth to children with major birth defects, such as cleft palate. Others taking it developed abnormal and potentially fatal heart rhythms.
Zofran Birth Defects
Though never approved as a treatment for morning sickness, many doctors prescribed the drug off label to pregnant women to control their nausea. "Off label" means the drug was not tested for safety or efficacy for treatment of morning sickness in a large-scale study and was not approved by the U.S. Food and Drug Administration for this indication.
A History Of Pushing Off-Label Use
The manufacturer of Zofran, GlaxoSmithKline LLC (GSK), has a history of illegally promoting off-label use of its drugs to doctors. The company pleaded guilty and paid a $3 billion fine to resolve its criminal and civil liability arising from unlawful promotion of other types of prescription drugs.
For some pregnant women, off-label use of Zofran led to heartbreaking birth defects in their babies, such as cleft palate. With cleft palate, tissue in the roof of the fetus' mouth does not correctly join. As a result, babies have problems feeding and talking. They may also have ear infections, hearing loss and problems with their teeth.
When a large company puts profits ahead of patient safety by illegally promoting off-label use of its drugs for unsuspecting patients, the attorneys of Reich & Binstock are here to hold it accountable. From our law offices in Houston, we handle Zofran personal injury lawsuits and class actions for clients in Texas and throughout the United States.
Abnormal Heart Rhythms And Zofran
Another health problem associated with Zofran is abnormal heart rhythms in adults taking the drug, including an abnormality known as Torsade de Pointes. The FDA required manufacturer GlaxoSmithKline to make several changes to the Zofran label in regard to this risk.
Injured By Zofran? Call Us For Help.
If you or someone you love has suffered serious side effects from Zofran, you may be entitled to compensation. Call 713-352-7883 or 877-643-3099 toll free or complete our simple contact form for a free and confidential consultation with an experienced Zofran lawyer.