Severe morning sickness can be difficult and painful to deal with as an expectant mother, but the last thing you would want to take is a medicine that may be linked to life-threatening birth defects in unborn children.

While the prescription drug Zofran® (generically known as ondansetron) is approved to treat nausea and vomiting in patients following chemotherapy or surgery, it has been prescribed off-label to treat morning sickness in expectant mothers. Some studies, however, have noted an association between Zofran use in the first trimester and birth defects such as congenital cardiac (heart) malformations.

Nov. 18, 2015

Case Update:  Motley Rice Attorney Appointed to MDL

Motley Rice medical attorney Kimberly Barone Baden was appointed as co-lead counsel for the multidistrict litigation In re Zofran (Ondansetron) Products Liability Litigation No. 2657 in the District of Massachusetts under Judge F. Dennis Saylor.

Attorney Kimberly Baden represents hundreds of children with birth defects allegedly caused by numerous pharmaceutical drugs, including Zoloft®, Effexor®, Topamax® and Zofran®. She previously litigated against GlaxoSmithKline in the Paxil® birth defect litigation and in July 2012 Kimberly was appointed to the Plaintiffs' Steering Committee in In re Zoloft (sertraline hydrochloride) Products Liability Litigation, MDL 2342.

Contact a Zofran Lawyer

If you or someone you know had a child with a birth defect following early prenatal exposure to Zofran, please contact medical attorney Kimberly Barone Baden by email or call 1.800.290.6612.

If you believe that you may have a claim, consider contacting an attorney as soon as possible.  A statute of limitations (SOL) may limit the time you have to file a claim. If you do not file your claim within the SOL, you may lose it forever.

Zofran Information

The injectable form of Zofran, which is manufactured by GlaxoSmithKline (GSK), was approved by the FDA in 1991 for the treatment of chemotherapy-induced nausea and vomiting. Oral dosage forms were approved in 1995 for the treatment of post-operative nausea and vomiting and an oral disintegrating tablet, Zofran ODT, was approved in February 1999. The first generic versions of Zofran were approved in 2006. Sandoz marketed the authorized generic for Zofran tablets and Zofran ODT.

There have been several studies that reflect an association between Zofran and severe birth defects, including an increased risk “for a cardiovascular defect and notably cardiac septum defect." The Toronto Star newspaper published an article in June 2014 that detailed many of the concerns we have with Zofran. Read the full article.

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News Coverage

CTV News (Dec. 7, 2015): Women say they weren't warned of possible side effects of anti-nausea drug