A blogger at Baby Center Community recently shared information about another drug to prevent nausea and vomitng during pregnancy besides Zofran with mothers who might be concerned considering all the recent litigation surrounding Zofran allegedly causing birth defects, specifically cardiac septum defect.
She recommends Kytril, saying that, “During its approval process, Kytril was shown to eliminate vomiting 88 percent of the time compared to 62 percent with Zofran. It also eliminated nausea 63 percent of the time with a lower incident rate of constipation and headaches.” She says that she personally has had a better experience with the drug than she did with Zofran during her first pregnancy.
Kytril is in the same drug class as Zofran. Both are category B for pregnancy, and both are approved specifically to treat nausea and vomiting in cancer patients and post-operative patients.
“My OB had never heard of it, which makes sense. Until recently, there was no reason to even look into an alternative to Zofran…. She gladly researched it on her own and came to the same conclusion. It was a better alternative….” the blogger wrote.
Yes, it does make sense that her doctor had heard of Zofran but not of its competitor, which has been around for more than 20 years, performs well and is affordably available in generic. Perhaps it is because Zofran’s manufacturer, GlaxoSmithKline (GSK), illegally marketed the drug in 2002 and 2004 as a morning sickness treatment, although it is not approved by the FDA for that purpose. GSK paid the Department of Justice billions in 2012 to settle allegations of illicitly promoting Zofran and several other drugs “off label.”
Fox 6 News in Birmingham, Ala., reported that “It remains a settlement that the DOJ calls the largest combined federal and state health care fraud recovery in a single global resolution in the history of the United States.” GSK was liable for prosecution under the False Claims Act ,which protects the government from those who wish to defraud government programs.
Kytril’s manufacturer, Roche, isn’t on the list of off-label promotion pharmaceutical settlements and perhaps that’s why its drug isn’t on OB doctors’ radar for women with morning sickness.
The blogger who brought up Kytril believes that Zofran is safe for pregnancy and spent time explaining the controversy surrounding it, but she didn’t mention this evidence of GSK’s disregard for the law and willingness to defraud the government agency that is there to “protect and promote YOUR health.”
There may be evidence that GSK is also willing to hide health risks to the patients who are its consumers. According to Law360, the 200-something families who are plaintiffs in the Zofran lawsuits told U.S. District Judge F. Dennis Saylor IV “that they have reason to believe that GSK has evidence about the link to Zofran and the alleged birth defects.”
“One of these studies revealed the same cardiac birth defect alleged by many of the complaints, the families said. Plaintiffs do not know whether GSK ever provided the FDA this or any other evidence of severe heart defects, the families said. What plaintiffs do know, however, is that the Zofran warning labels and available marketing materials were silent as to such evidence,” Law360 reported.