Zofran is a drug that was approved to treat nausea and vomiting in chemotherapy and surgery patients. It was first approved in the United States in 1991 and was developed by GlaxoSmithKline (“GSK”). While Zofran was not approved by the FDA for use in treating morning sickness with pregnant women, evidence came to light that GSK drug sales representatives were encouraging doctors to use Zofran to treat morning sickness in women. This is based on the fact that in 2012, GSK, the maker of Zofran, pled guilty to federal criminal healthcare charges for violations of the FDA. It agreed to pay $1 billion in criminal penalties, as well as $2 billion in civil penalties to resolve a federal whistleblower suit that included claims that GSK wrongfully promoted Zofran for off label promotion for use in expectant mothers, and paying kickbacks to doctors to prescribe Zofran for off label use. It is said that the $3 million penalty is one of the largest combined federal and state healthcare fraud recovery in the history of the United States.
While the maker of Zofran encouraged doctors to use Zofran to treat morning sickness in pregnant women, Zofran was not approved by the FDA for use in pregnancy. In fact, the FDA classifies Zofran as a “pregnancy category B” medication, which means animal studies have not found evidence of a risk to pregnant women babies, but no one knows if it is safe.
Recently, reports have been coming out from various medical journals indicating a link between Zofran birth defects and the use of Zofran during pregnancy. In particular, a December 9, 2014 report in the Toronto Star found several serious <strong>Zofran birth defects</strong> from women that had taken Zofran in the first trimester of their pregnancy. Some of these horrible outcomes included two fetal deaths, heart and kidney malformations, and atrial septal defect.
In August 2013, a group of researchers looked at a Danish registry and studied nearly 900,000 pregnancies over a 13 year time period. They found that Zofran was associated with a doubled risk of heart defects, leading to a 30% increase risk of birth defects overall. Zofran birth defects have included heart defects, cleft lip, cleft pallet, fetal growth restriction, kidney defects, life threatening pregnancy complications, and death.
The attorneys at <a href=”http://mainstinternetmarketing.com/lf-del/”>NGK Law</a> are investigating Zofran lawsuits and Zofran birth defects based on the studies and information that continues to come up regarding dangerous Zofran side effects. NGK Law has handled cases involving Lexapro birth defects and Lexapro side effects, as well as Zoloft lawsuits including Zoloft birth defects and Zoloft side effects. In the same regard, NGK Law is committed to speaking with the mothers of children that have suffered from Zofran birth defects and investigating whether or not these children may have a claim for a Zofran birth defect lawsuit. <strong>Contact NGK Law at 1-844-5-NGKLAW or 314-241-1919</strong> or fill out our contact form on the side of this page to determine whether or not you or your child has a basis for a Zofran birth defects lawsuit. We look forward to working with you to investigate your potential Zofran side effects lawsuit.