PITTSBURGH — Several dozen lawsuits have now been filed against the maker of a drug used to fight morning sickness in pregnant women.
While many women say they had no problem with taking ondansetron, which is marketed under the brand name Zofran, others say it caused significant health problems for their children.
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“It was crushing. It was a terrifying experience,” Ashley Wright said.
Ashley Wright says the first days after the birth of her son, Kaleb Wright, were a nightmare.
“Struggling, sitting up, wondering and crying every night if your baby is going to make it through the next night,” she said.
Kaleb wasn't eating, and when he did, he had bouts of endless choking. He was diagnosed with a severe cleft palate that was further complicated with bad reflux.
Now 10 years old, Kaleb is better. But his mother says he still has lingering effects from the struggles during his first year of life.
Ashley Wright blames Zofran, which she took for morning sickness when she was pregnant.
“They were telling the doctors this is a great anti-nausea drug, which we don’t dispute it, but what they weren’t saying is that they had never gotten approval for use in pregnant women because there were no tests,” Elizabeth Graham, an attorney for families, said.
Graham represents more than 200 families, including the Wrights, who are suing GlaxoSmithKline, the maker of Zofran.
While the drug was approved for chemotherapy patients to treat nausea, it was never given Food and Drug Administration approval as a remedy for morning sickness. The FDA allows medicines to be prescribed “off label,” or for a use other than it was approved for. However, the company can’t market the drug that way.
In 2012, the Department of Justice slapped GlaxoSmithKlinewith a $3 billion fine for “unlawful promotion and failure to report safety data" of several drugs, including Zofran.
That's the basis of dozens of lawsuits, but in a statement to Channel 11 News, the company called the lawsuits “unfounded.”
GlaxoSmithKline points to an October 2015 FDA letter in which the FDA wrote the evidence presented "is not sufficient to conclude that there is an increased risk of birth defects, including cleft palate.”
In fact, there are conflicting studies.
“You’re not sure if the medication is causing the problem or if it’s something else. That’s the difficulty with any study,” Tamara Takoudes, the director of Maternal Fetal Medicine Services.
Zofran is continues to be prescribed to this day.
While most women report having no problems, Ashley Wright wants other women to know her story to decide for themselves.
She also had a message for the makers of Zofran.“I just don’t think it’s fair that you’re giving us stuff that hasn’t been tested and you don’t know what it’s going to do for us,” she said.
Zofran, though, was originally meant to be used by cancer patients, and according to a study published in the New England Journal of Medicine, "Despite the prevalent use of this drug during pregnancy, data that support its safety for the fetus are limited."
Women considering using the drug should weigh the risks with their doctor.