Drug giant, GlaxoSmithKline, started marketing Zofran in the US in 1991. Unfortunately, GSK marketed the drug “off-label’ (which means marketing a drug or device for a purpose other than approved for – full definition here). Instead of marketing to doctors treating cancer patients and those suffering from nausea as a result of surgery, which was the purpose approved by the FDA, GSK promoted Zofran as an anti-nausea drug for women during pregnancy, and in general as just an anti-nausea drug. There were also several allegations involving a number of drugs including Zofran. These subsequently became part of a GSK – US Government settlement of allegations of unlawfully giving kick-backs to doctors.
What Did GSK Know About The Risks Of Zofran If Ingested During Pregnancy?
As outlined in our about section, GSK performed testing on rabbits and rodents back in the early 1980s. These tests were used by GSK recently to say that these tests did not evidence a link between birth defects and the drug. However, in that same statement, they stated that they have performed many studies in the past on rodents that did not translate in to similar risks in humans.
GSK further acquired knowledge of two incidents of child birth defects in 1991 where the mother took Zofran for severe morning sickness during the first trimester.
Zofran was approved for use by the FDA as a treatment for nausea in cancer victims in 1991. Subsequently, GSK began the off-label marketing of Zofran with no warnings of the risks of taking Zofran during pregnancy.
As the years passed, more cases of child birth defects were reported to GSK (32 by 2000, and over 200 as of the end of 2014). Again, GSK did nothing to issue warnings or amend the labels about pregnancy risks. In fact, their advertising campaigns were stronger than ever, using promotional statements such as “Zofran Can” and referring to it as “24 hour control”.
In addition, GSK was aware of numerous epidemiology studies that issued reports linking Zofran and several child birth defects. For a detailed analysis of each scholarly study, visit our about Zofran section.
All of the above information indicated what GSK could know about the risks. It will be up to the courts to determine if this information will amount to actively promoting a drug which they could have known was unsafe for use in pregnant women. GSK made billions of dollars from the sales of Zofran for use on pregnant women. Our investigation seeks to reveal what and when GSK knew about the safety or danger of Zofran to the developing fetus.
FDA Investigates Zofran Manufacturer For “Off-Label” Promotion To Pregnant Women
In 1999, the FDA became aware of the off-label marketing of Zofran and issued a communication that the advertising is “false and misleading” (source: http://www.justice.gov/). They ordered GSK to: “immediately cease distribution of this and other similar promotional materials for Zofran that contain the same or similar claims without balancing risk information” (source: fda.gov/). Further, while the drug was never approved for use for nausea in pregnant women, GSK promoted Zofran in its prescription instructions by labeling the drug as “Pregnancy Category B” on the five letter categorization system, which indicates the potential for a drug to cause a child birth defect if used during pregnancy. The scale includes A, B, C, D and X.
GSK Settles Lawsuit With US Government For $3 Billion
This non-compliance lead to a federal investigation which culminated in the largest pharmaceutical settlement with the US Government in 2012. In this settlement GSK made the following statements about GSK:
- “promoted the sale and use of Zofran for a variety of conditions other
than those for which its use was approved as safe and effective by the
FDA (including hyperemesis and pregnancy-related nausea)”
- “made and/or disseminated unsubstantiated and false representations
about the safety and efficacy of Zofran concerning the uses described
in subsection (a) [hyperemesis and pregnancy-related nausea]”
- “offered and paid illegal remuneration to health care professionals to
induce them to promote and prescribe Zofran”
Source: Extract from Settlement Agreement, p. 5, July 2, 2012.
Ondansetron / Zofran The 4th Most Prescribed Drug In The US & Sales
Why did they do this? We can not know for sure what was in the mind of people at GSK until discovery takes place in the currently filed cases. The statistics show that this “off-label” market is enormous. So there was a lot of money made by GSK from the sale of Zofran to pregnant women. Specifically, vomiting and nausea (also known as VPN) occurs in more than 70% of pregnancies in the United States. The severity of nausea varies greatly from pregnancy to pregnancy. The lower the severity, the more likely alternative anti nausea measures are taken, such as home remedies. The more severe cases resulted in doctors issuing a prescription for Zofran. Statistics show that this resulted in about 10-15% of pregnant women taking a prescription for morning sickness. Since a safe prescription alternative to Zofran was not approved until 2013 (Diclegis), Zofran dominated the off-label market and became the fifth most prescribed drug in the US between 2004 and 2008. This market dominance continued through 2013 where GSK was profiting from over 1,000,000 pregnant women taking the drug for severe morning sickness every year.
Zofran Sales 2003-2006 Makes GSK Billions Of Dollars
GlaxoSmithKline’s patent expired in 2006 where Zofran became a generic drug, however GSK continued in the market. Given all the FDA warnings and potential links of birth defects to pregnant women taking Zofran, it is clear from the following sales that GSK was motivated by dollars. Below is a listing of sales of Zofran from 2003 through 2006:
- 2003 – $ Sales: $463,726,000
- 2004 – $ Sales: $495,657,000
- 2005 – $ Sales: $463,726,000
- 2006 – $ Sales: $645,411,000