The prescription drug Zofran, made by drug maker GlaxoSmithKline, is under fire for unapproved use. Most recently, the popular nausea drug has been linked to birth defects.
Zofran was initially approved by the U.S. Food and Drug Administration (FDA) to help cancer patients that were experiencing nausea after treatments and/or surgery. The drug maker found to be offering the medication to pregnant women that were suffering from morning sickness. However, it was never approved by the FDA for use by pregnant women.
Glaxo plead guilty in 2012, to federal charges of fraud and illegal promotion of several of its drugs, which included Zofran. The company paid $3 billion as part of a settlement. Now, the company is headed back to court for more allegations involving Zofran (generic name ondansetron).
Zofran Linked to Birth Defects
According to court documents, Glaxo was aware as early as 1992 that Zofran presented “unreasonable risk of harm” to developing babies because the medication passes through the placenta. Despite knowing this, the drug giant continued marketing the medication to pregnant women.
Several lawsuits are currently pending on behalf of children that contend the manufacturer failed to adequately warn about the risk associated with use during pregnancy. Of the main claims the suits allege Glaxo advertised the drug as a safe treatment for morning sickness even though it was not approved for this use and thereby failed to warn the public about dangerous side effects.
Here is a video highlighting the human cost of Zofran’s awful side effects:
In fact, a study in the December 2014 issue of American Journal of Obstetrics (AJOG), led by Dr. Gideon Koren, highlights the serious risks of pregnant women taking Zofran as well as conflicting studies that can’t eliminate the risk to a fetus.
“There is no reason for pregnant women to be exposed to a drug of unproven maternal and fetal safety” when there are safer options available, wrote Dr. Gideon Koren.”
An estimated 80 percent of pregnant women suffer with nausea or vomiting during pregnancy (NVP) and nearly 1 million pregnant women are exposed to Zofran as well as its generic version, yearly, Koren said.
As more information is brought to light about the horrific side effects associated with Zofran, the worse the situation is becoming for Glaxo. The fact that this drug manufacturer knew about these Zofran side effects years ago and failed to take reasonable steps to ensure pregnant women were not prescribed this drug is truly disturbing.
If you or a loved one is suffering serious side effects from Zofran use, take a moment to review this page to learn more about your legal options.