Zofran Linked to Birth Defects

Zofran, a popular medication prescribed for nausea and vomiting, has been linked to birth defects. Developed and approved by the US Food and Drug Administration to help ease nausea in patients undergoing cancer treatment or surgery, GlaxoSmithKline-made Ondansetron, marketed as Zofran, is on the World Health Organization’s List of Essential Medicines, a list of medications needed in a basic health system. That’s a major accomplishment for drug makers. But a rise in unapproved use of Zofran to treat morning sickness, nausea and vomiting in pregnant women has proven dangerous.

Multiple studies link the drug to severe birth defects in babies whose mothers used the drug while expecting. Most alarming is that court documents show that GlaxoSmithKline (informally known as Glaxo) knew as early as 1992 that Zofran placed developing babies at unreasonable risk of harm because the drug passes through the human placenta. Still, the company continued to market the drug as a safe and effective treatment for pregnant women. In 2012, Glaxo officials pleaded guilty to federal charges of fraud and illegal promotion of several drugs, including Zofran, and paid $3 billion as part of the legal settlement. Now, the company is back in court to answer to allegations that it:

• Failed to determine safety risks before selling it;
• Failed to warn the public about dangerous side effects;
• Falsely advertised the drug as a safe treatment for morning sickness and hyperemesis gravidarum (severe or prolonged vomiting) even if it was not approved for this use;
• Misrepresented that animal studies showed the drug was safe, when in actuality the results showed abnormal bone growth and signs of toxicity;
• Failed to properly evaluate all data and safety information on Zofran for use in pregnant women;
• Produced a defective drug;
• Falsely and fraudulently claimed Zofran was safe for pregnant women.

If you are expecting or planning a pregnancy, know that Zofran remains unapproved by the FDA for use in pregnant women, though roughly 1 million women still take the medication or its generic counterpart each year. If you have been prescribed Zofran or believe that the drug may have affected your child, contact an experienced dangerous drug attorney with Jacksonville’s Harrell and Harrell at 800-251-1111.