November 4, 2015– A new lawsuit claims Zofran caused several different birth defects. Deana Brown firmly believes that the anti-nausea drug she took in the first trimester of her pregnancy left her child deformed, and she is determined to make GlaxoSmithKline, the manufacturer, pay.
Brown’s daughter was born with amniotic band constriction and teratologic clubfoot deformity, both conditions that affect the development of a child’s limbs, hands, and feet. In the lawsuit, Brown’s lawyer alleges that GSK hid a known risk of harm linked to Zofran, and that “her child would never have been injured” if she had been properly warned of the drug’s serious side effects.
Brown isn’t alone in her anger. Her lawsuit is the 193rd Zofran-related lawsuit this year alone. Beginning in the middle of October, Zofran cases are now being consolidated into multidistrict litigation, or MDL, in the District Court of Massachusetts, and law firms are bringing forth plaintiffs.
Zofran & The FDA
The FDA classifies Zofran as a Category B pregnancy drug, meaning the medication’s safety during pregnancy has been studied on animals but not in humans. The FDA advises, “Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”
Zofran on-label is used to treat nausea and vomiting due to chemotherapy, but doctors have long been prescribing the drug off-label for severe cases of morning sickness during pregnancy. Currently, there is only one medication FDA-approved for morning sickness: Diclegis. This drug was recently seen on Kim Kardashian’s instagram, the reality star promoted the drug without warning consumers of the side effects and, as a result, received an FDA warning. While off-label prescriptions are a fairly common medical practice, drug companies are not allowed to promote products for uses that aren’t approved by the FDA. This is what has GSK in hot water with the law.
Back in 2012, GSK pleaded guilty to the unlawful promotion of several different drugs, including Zofran, and settled for $3 billion. The Justice Department stated that, at the time, it was “the largest healthcare fraud settlement in U.S. history and the largest payment ever by a drug company.” As part of the settlement, the manufacturer conceded that they “knowingly 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 or pregnancy-related nausea).”
This admission is crucial to Brown’s case, and many other lawsuits against GSK. Dr. Jennifer Gunter, a Bay Area OB/GYN took Zofran herself for severe nausea during pregnancy, and her son was born with heart defect. However, she doesn’t blame the drug for her son’s medical condition.
In a blog post regarding Zofran, Gunter reviewed the conflicting research on Zofran and wrote, “Medications should never be the first line for nausea and vomiting. There are other things to try first, but for some women, like me, these things will fail and then every woman has to decide her individual risk-benefit ratio.”
While Gunter makes a valid point, pregnant mothers should also be given the ability to weigh those risk-benefit ratios by knowing all the side effects and possible adverse events that could occur with Zofran usage. This is a main concern in not just Brown’s case, but hundreds of other mothers. If they had been properly warned about Zofran, they could have avoided taking a medication that did not work well with their body and unborn child.
Some have compared the recent media attention Zofran has received to the drug Bendectin in the 1970’s and 1980’s. The controversy surrounding the drug was similar to Zofran in that hundreds of birth defect cases were consolidated into MDL. By 1983, manufacturer Merrell Dow voluntarily recalled the drug, the only FDA approved morning sickness drug at the time.
FDA Reaffirms Zofran’s Category Risk
In a letter published on October 27th, the FDA reaffirmed Zofran’s classification as a Category B drug. The letter came only two days before Brown filed her lawsuit against the manufacturer. When asked about the FDA classification, Brown’s lawyers claimed that GSK had evidence from their animal studies of “several concerning trends related to fertility and fetal development” linked to the use of Zofran but continued to “launch and market” the drug.
Brown’s lawyer went on to say:
“If GSK was truly concerned about providing an option for women with severe morning sickness, GSK should actually study the effects of its own drug on pregnant women rather than subjecting unborn children and their families to unknown and untested side effects. Certainly GSK has the resources to conduct proper clinical trials prior to launching its product, its decision makers just chose not to.”
If you, or someone you love, has been effected by Zofran, it’s not your fault. It’s the manufacturer’s responsibility to give doctors all of the information about the drugs they are prescribing, and GlaxoSmithKline has been accused of neglecting to do so. Don’t let drug companies get away with unlawful marketing.
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Source: The Daily Beast