Zofran History

A History of Prescription Drugs Used To Treat Morning Sickness

In 1956, a combination of doxylamine and vitamin b6 was introduced to the US market as Bendection. This was an FDA approved drug used to address nausea and vomiting in pregnant women. However, in 1983, the manufacturer removed it from the market because they were facing numerous lawsuits that said the drug caused birth defects.

From 1983 to 2013, there was no FDA approved drug for treating morning sickness in women. The removal of Bendection from the market caused many doctors to prescribe off-label drugs to their patients, most commonly Zofran.

Zofran, or Ondasetron, is a 5-HT3-receptor antagonist, and was approved by the FDA in 1991 for use in preventing nausea and vomiting normally induced by chemo and radiation therapy. In less than 15 years, it became the 20th high-selling brand-name drug in the United States and made $1.3 billion in the first 9 months of 2006.

Zofran and the Generic Landslide of Prescriptions

Zofran was already a huge success when it became a generic prescription in 2007. This lead to a mass increase in prescriptions for the drug, many of which were for off-label uses like treating nausea in pregnant women.

And while prescribing a drug for off-label use is the standard of care for many of the drugs used during pregnancy, including the use of steroids to prevent respiratory distress syndrome, Zofran was different.

There have been multiple warnings from the FDA about Zofran’s potential to cause defect and injury in babies. The most recent warning came in 2013, which linked Zofran to Serotonin Syndrome. The FDA has said explicitly “Zofran should not be taken during pregnancy”.

Yet, in spite of the research and warnings, doctor’s continued to prescribe Zofran because there was no FDA approved drug to treat their patient’s morning sickness. This played a large part in the increase of 50,000 prescriptions a month of Zofran in 2008 to 110,000 a month at the end of 2013.

Over A Million Pregnant Women Affected

If you run those numbers, almost ¼ of all pregnant women in the United States every year were prescribed a drug that had a very tangible link to serious birth defects.

If your baby was born with a heart defect, cleft lip or palette, or musculoskeletal anomalies, and you took Zofran during your first trimester, there is a good chance that Zofran is responsible.

To complicate things further, GlaxoSmithKline, the maker of Zofran, paid a fraud lawsuit for promoting Zofran for the off-label use of treating morning sickness. They actively wanted doctors to prescribe a drug that been linked to multiple birth injuries.

In spite of that, the settlement did not include any payments for injuries caused by the use of Zofran.

You and your child may be entitled to compensation for pain and suffering, loss of income, medical costs, and other damages. If you took Zofran during your first trimester and your child was born with a defect, you should contact an experienced birth injury attorney now.

A Brighter Future For Those Suffering From Severe Morning Sickness

No doubt in response to the growing need for an FDA approved drug to treat morning sickness, the FDA approved the return of Bendection under the new trademark name of Diclegis on April 8th, 2013.

As of March 2015, Diclegis is the only FDA approved nausea and vomiting prevention drug for pregnant women on the market.