Zofran: America’s Leading Morning Sickness Drug
Zofran Birth Defect Lawsuits
Zofran was approved by the US Food & Drug Administration in 1991. Initially, the drug was designed and cleared for the treatment of nausea and vomiting caused by potent cancer treatments like chemotherapy. Its approval would be further extended to cover patients suffering from nausea during rounds of radiation therapy and for patients who experience nausea after going under anesthesia. It was never, and is still not, approved for the treatment of morning sickness. But no sooner had Zofran been released onto the US market than physicians across the country began using it to treat nausea and vomiting during pregnancy.
By 2009, Zofran was America’s most popular pharmaceutical treatment for morning sickness. In that year, the drug overtook promethazine, its closest competitor. GlaxoSmithKline never looked back. In 2013, more than twice as many women were being prescribed Zofran during pregnancy as promethazine, according to numbers from IMS Health, the nation’s largest aggregator of prescription data.
How did that happen? How was Zofran able to capture an entire population of patients for whom it wasn’t even approved? Here are two theories:
With No Other Treatment, Doctors Had To Choose Something. They Chose Zofran.
Before Zofran came along, there weren’t any drugs approved to treat morning sickness in the US. Bendectin, the last nausea medication approved for use during pregnancy, was withdrawn from the market way back in 1983. That had huge effects.
For one, Bendectin’s removal from use led to a drastic increase in pregnant women being hospitalized for severe nausea. The year after Bendectin’s withdrawal, hospital admissions for excessive vomiting among pregnant women increased by 50%, according to an article published in the Canadian Journal of Public Health. Bendectin’s effective recall left a huge hole in the market; millions of women were getting pregnant, most suffered from morning sickness, but there was no drug to treat them.
Then Zofran, a new option for nausea, was approved. Of course, it wasn’t approved for pregnant women, but that’s never stopped physicians from trying drugs out in new patient populations. Researchers at Dartmouth have found that 1 out of every 5 prescriptions is “off-label,” written for an indication that the drug was never approved for. Perhaps more troubling, at least 15% of those off-label prescriptions have no medical science to back up either their safety or effectiveness. Be that as it may, doctors began trying Zofran out on their patients with morning sickness, and it worked. Word spread, and soon 1 million pregnant women were getting the drug every year.
GlaxoSmithKline Allegedly Promoted Zofran Illegally For Use During Pregnancy
The other theory to explain Zofran’s unprecedented popularity was first floated by the US Department of Justice. It’s a lot simpler: GlaxoSmithKline was marketing Zofran to doctors as a safe and effective morning sickness drug. That, as you might expect, would be illegal.
While doctors have every right to prescribe drugs off-label, pharmaceutical manufacturers are only allowed to promote their products for approved uses. GlaxoSmithKline, however, had been telling obstetricians and gynecologists to try Zofran in their pregnant patients, going so far as to imply that the drug had been demonstrated safe during early fetal development, federal prosecutors alleged. According to the Justice Department, the company had even set up a system of illegal kickbacks to compensate physicians who sold a lot of Zofran.
In 2011, the US government took GlaxoSmithKline to court, in part for unlawfully promoting Zofran. After a year-long legal battle, the company’s attorneys hammered out a settlement agreement, one that didn’t require GlaxoSmithKline to accept any liability for its alleged off-label promotion of Zofran. Despite never claiming responsibility, the company agreed to pay the government $3 billion. It remains the largest settlement for alleged health care fraud in US history.
Zofran & Birth Defects: Studies Find Troubling Link
But the Justice Department’s case didn’t have anything to do with whether or not Zofran was actually safe for pregnant women to take. The government’s lawsuit only looked into how GlaxoSmithKline had marketed the drug, not whether it could cause birth defects in children. That difficult task would be left to medical researchers who, at the end of 2011, began investigating Zofran’s effects on fetal development.
Harvard Study Shows Increased Risk For Cleft Palate
In January of 2012, a team of researchers from Harvard University and Boston University’s Slone Epidemiology Center published “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects” in the journal Birth Defects Research. The study took an exhaustive look at common morning sickness treatments and their potential links to fetal harm.
Using patient interviews and hospital records, the team realized that women who were prescribed Zofran seemed to have more babies with cleft palate than women who weren’t. Far more, actually. The risk of delivering a child with cleft palate jumped by 237% when Zofran was added to the equation.
In Denmark & Sweden, Congenital Heart Defects Rise With Zofran
Troubled by the widespread use of Zofran during pregnancy, Danish researchers from Copenhagen University dove into their own country’s health records to investigate the drug’s potential effects. Analyzing prescription and birth records from more than 900,000 pregnancies, the team discovered a shocking association between Zofran and congenital heart defects.
Women taking Zofran are:
60% more likely to have a child with any heart defect
2.1 times more likely to have a child with an atrial septal defect
2.3 times more likely to have a child with a ventricular septal defect
4.8 times more likely to have a child with an atrioventricular septal defect
Notably, the researchers only looked at women who had taken the drug during their first trimester, when a baby’s cardiac tissues are beginning to form. Their results were released in 2013 and followed quickly by a similar study from Sweden.
Swedish government researchers reviewed every birth record filed in Sweden between 1998 and 2012, a total of more than 1 million pregnancies. As in Denmark, women prescribed Zofran were more likely to have babies with heart defects. The team noted a 60% increase in the rate of all heart defects and a more than two-fold rise in the risk for “cardiac septal defects,” a category of abnormalities that includes atrial, ventricular and atrioventricular septal defects. The study, ultimately published in the December 2014 edition of Reproductive Toxicology, provided damning corroboration for the findings in Denmark, sparking a wave of litigation that experts say has only begun.
Hundreds Of Zofran Lawsuits Say Drug Caused Birth Defects
Parents are now filing civil lawsuits against GlaxoSmithKline, claiming its potent anti-nausea drug caused their children to be born with birth defects. Families across the nation say the company treated expectant mothers like “human guinea pigs,” promoting an unproven drug with devastating consequences. The first lawsuit was filed in February of 2015, and a steady stream has followed since.
While these lawsuits were initially filed in federal courts across the country, they have been formally transferred to the US District Court of Massachusetts in Boston. Now consolidated as a “Multi-District Litigation,” the lawsuits will head through all-important pre-trial proceedings together. But prominent members of the legal community say the fact that the Zofran litigation has been consolidated doesn’t restrict the rights of other families. Parents who gave birth to children with birth defects after being prescribed Zofran may still be able to file suit.
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