The History of Zofran & Its “Off Label” Use
Insight from Dedicated Pharmaceutical Attorneys
Developed nearly two and half decades ago to help both cancer and surgery patients manage their heavy nausea and vomiting, Zofran has gained much attention and criticism recently over the birth defects and medical conditions linked to its usage. When GlaxoSmithKline (GSK), a multi-billion dollar pharmaceutical company, first created the drug, there was no testing or approval given for the drug to be given to pregnant mothers. However, less than 10 years ago, things began to change. In 2006, the U.S. Food & Drug Administration (FDA) gave approval for generic version of Zofran, or ondansetron, to be used.
Soon, many doctors began prescribing this medication for “off label” uses, or uses that the medication was not intentionally developed or tested to treat. One of the many groups that was commonly prescribed this drug for “off label” usage was pregnant women suffering from extreme morning sickness, known as “Hyperemesis Gravidarum.” The condition only occurs in about 1 in every 100 pregnancies, however, it does cause serious risk to the fetus and mother.
The condition can require many pregnant women to remain hospitalized to manage symptoms, such as:
- Acid reflux
- Nutrition loss
- Electrolyte imbalances
- Muscle problems
- Other similar issues
What Justification Was Used to Prescribe the Untested Zofran?
Several doctors believed that Zofran may be useful for treating this extreme morning sickness. As there was no other drug available to help pregnant women suffering from this condition, Zofran surfaced as a potential option. Since it is known to suppress the release of serotonin and force the stomach to empty faster, it is considered to help a person avoid the likelihood of vomiting. Furthermore, GlaxoSmithKline had educated doctors to view Zofran as an effective and appropriate antiemetic, or anti-nausea drug and allegedly encouraged them to promote it.
Though this may seem to make sense in theory, many controversial facts about the drug have surfaced over the last several years. It is important to note that the FDA still never approved ondansetron for use by pregnant women. In addition to that, “safety data” for the drug was only pooled from 200 fetuses—that is a small percentage considering millions of women have been prescribed this drug during pregnancy.
Zofran is also known to be a “Pregnancy Category B” drug, which means though animal trials showed no red flags or dangerous side effects, it cannot be said whether or not the drug is safe for use during pregnancy. Despite this questionable evidence, more than one million pregnant women were prescribed Zofran in 2013.
Legal Action Against GlaxoSmithKline Over Zofran
Many women who have suffered medical conditions and have watched their children endure defects after being prescribed Zofran have taken action. However, the Justice Department took the first step by suing the company for illegally promoting and marketing the drug to pregnant women in addition to several other infractions. In 2012, GSK agreed to pay $3 billion, the largest health care fraud settlement in the country’s history at the time. In 2015, several mothers filed lawsuits against the pharmaceutical company for alleging causing defects to their children due to the use of Zofran. It is likely that a mass tort will arise against GlaxoSmithKline when other plaintiffs step forward.
Have questions about the damaging side effects Zofran can cause? Believe
you may have a case to bring forward?
Call Arnold & Itkin today to discuss your medical situation.