COVID-19 Delays First Zofran Trial

COVID-19 Delays First Zofran Trial

Introduction

The first bellwether trial against GlaxoSmithKline's anti-nausea medication Zofran has been postponed due to the coronavirus pandemic.

In a monthly status conference, held via telephone, U.S. District Judge F. Dennis Saylor IV in Massachusetts, said that there is no timetable for a case that will go for trial, which was slated to begin May 4. The parties have also been asked to let the U.S. Food and Drug Administration know about the uncertain delay.

Zofran (Ondansetron) manufactured and originally marketed by GlaxoSmithKline is an antiemetic drug used for nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery, and gastroenteritis. US FDA approved Zofran in January 1991.

While Zofran was never tested or approved for use by pregnant women, it is often prescribed off-label for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss.

In the past few years, however, disturbing results from a number of studies surfaced linking Zofran to congenital birth defects. Mothers and families of babies born with serious mental and physical deformities are now pursuing lawsuits against the medication's maker, claiming they were misled and lied to about the drug's risks and safety.

The lawsuits were consolidated in Massachusetts in 2015, which claimed that GSK promoted Zofran for morning sickness despite having any evidence of its safety for pregnant women, and only having FDA approval for the treatment of nausea related to cancer and surgery.

GSK is prompted to end all of the 419 lawsuits, referring to the federal preemption because the FDA rejected a warning label. The company filed a citizen petition with the FDA arguing that, even with additional information about the drug presented to the federal government, a warning label would still not be required. GSK says, If the FDA agrees with the citizen petition, then it would likely resolve the preemption issue.

Another telephone conference has been scheduled for April 15, where Judge Saylor indicated that a trial schedule would be discussed.