BOSTON - A popular drug many moms take to fight morning sickness is now the subject of a lawsuit claiming it causes birth defects.
More than four dozen lawsuits have been filed by mothers who say their and their child's lives have been ruined by the medication.
Beth Botelho's world was shattered just after she delivered her daughter Marissa. Doctors noticed the newborn had breathing problems, and then discovered a congenital heart defect.
"It was apparent something was really wrong," Botelho said. "She needed open heart surgery. She was on life support. She was on a feeding tube. Initially, it was very overwhelming."
Botelho blames the heart defect on a drug she took during pregnancy called Zofran. It is FDA approved to treat nausea in cancer patients, but it is sometimes prescribed off-label for morning sickness.
"It was never approved, tested or vetted for pregnant women, and that's what's so egregious in this case," said attorney Walter Kelley.
Kelley represents Botelho in her lawsuit against the drug manufacturer, GlaxoSmithKline. There are nearly 60 lawsuits nationwide, now consolidated in a Massachusetts court.
"Our primary goal, is one, to make sure these children have the resources necessary so they have the best possible medical care for the rest of their lives," Kelley said.
In 2012, Glaxo agreed to pay $3 billion in a settlement with the Department of Justice for what the D.O.J. called the "unlawful promotion" and "failure to report safety data" of several drugs, including Zofran.
The company told FOX25: "We believe that the recently filed lawsuits involving Zofran are entirely unfounded, and urge people to review FDA's recent letter evaluating the scientific allegations at the heart of this litigation.
Zofran has been approved since the early 1990s for use in preventing nausea and vomiting associated with chemotherapy and that can occur after surgery. It has proven to be a valuable treatment option for many people. Throughout the 24 years that Zofran has been available in the U.S., there has been little to no litigation claiming associations with birth defects until now. In an effort to find potential clients, plaintiffs' attorneys have spent millions of dollars on misleading, unsubstantiated advertisements and have filed numerous lawsuits seeking financial damages.
On October 27, 2015, the FDA denied a citizen position to change the pregnancy risk drug category for Zofran. The FDA stated that 'we do not agree with the Petition that the available data reviewed by FDA in connection with the Petition warrant a conclusion that ondansetron use during pregnancy poses an increased risk of fetal or maternal adverse outcomes.' The FDA also declined to notify physicians of the petitioner's views of the studies, finding that any 'notification to OB/GYNs that ondansetron may lead to adverse maternal or fetal outcomes is not necessary and could be misleading.' We appreciate the FDA providing clarity on the current state of the science for Zofran and hope the agency's letter will properly inform this litigation. We will continue working with the FDA, physicians and patients on monitoring and evaluating the safety and efficacy of our products."
In fact, there are conflicting studies if the drug causes heart defects, cleft lip, or cleft palate.
"You're not sure if the medication is causing the problem or if it's something else. That's the difficulty with any study," said Tamara Takoudes, Director of Maternal Fetal Medicine Services at South Shore Hospital.
Takoudes says Zofran is effective for morning sickness but believes it shouldn't be used as a front line therapy.
"I think because of the controversy and data out there now again, we should be more careful about prescribing it too early in pregnancy until we have more information," Takoudes said.
Botelho says her daughter is small for her age and has difficulties with school. More troubling, she says that she doesn't know what her long-term medical outlook looks like.
"My hope is that if we can make her life a little bit easier, given that life is going to be a little bit of a struggle for her, I hope we can do that," Botelho said.
A Massachusetts judge met with attorneys Tuesday to work out logistics, but a decision could be years away.
One thing to note - many women were prescribed the generic version of Zofran, but the law doesn't allow the generic manufacturer to be held liable. Only those who took Zofran can file a lawsuit.
Just a few hours ago, we received an updated statement from Glaxo Smith Kline. They told us that late last month, the FDA denied a citizen position to change the pregnancy risk for Zofran.
The company said, "We appreciate the FDA providing clarity on the current state of the science for Zofran and hope the agency's letter will properly inform this litigation."
To read the entire FDA denial, click here.
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