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Pressure mounts on Zofran that may cause birth defects

Staff writer |
Since the first Zofran birth defects lawsuit was filed in February this year, seven other claims have been brought against GlaxoSmithKline (GSK).

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The plaintiffs allege that the anti-nausea drug used during pregnancy caused their children to be born with birth defects. Further, the FDA never approved Zofran to be used during pregnancy.

Zofran Birth Defects Lawsuits on the RiseGSK is accused of illegally marketing Zofran as a safe treatment for morning sickness. While it is lawful to prescribe drugs off-label, it is unlawful to promote drugs for any uses that have not been FDA approved.

The first lawsuit filed claims that two children were born with congenital heart defects, a condition that will impair physical and developmental growth. The lawsuit also claims that GSK began receiving reports of Zofran birth defects as far back as 1992 - just one year after it was FDA approved to prevent nausea during cancer chemotherapy.

Two more lawsuits were filed at the beginning of April, U.S. District Court, Northern District of Alabama; and U.S. District Court, District of Montana. Both complaints allege that Zofran caused birth defects: one baby was born with a cleft palate after her mother took Zofran for morning sickness in her first trimester and the other baby was born with congenital heart defects.

About two weeks later a Texas woman filed suit against GSK claiming that her eight-month-old child will need multiple surgeries to correct Zofran birth defects. Her baby suffers from “heart murmur, fluid on the brain, thickened arteries and multiple developmental delays,” according to Monheit Law.

About 10 years ago a number of studies were conducted on Zofran’s effects during pregnancy. Researchers found an association between the anti-nausea drug and birth defects, notably cleft palate and congenital heart defects. Even before Zofran was approved, GSK conducted several tests on rodents and rabbits. The results showed fetal malformations and intrauterine deaths.

In 2011, a study published in the Birth Defects Research Journal found that women who took Zofran during pregnancy may be 2.37 times more likely to have a child with a cleft palate.

And last October, Reproductive Toxicology published a study that showed an increased risk of cardiovascular complications in babies whose mothers took Zofran during their first trimester. No clinical trials involved pregnant women.

Despite years of evidence and mounting lawsuits, GSK still hasn’t changed Zofran’s (ondansetron) label to include warnings of birth defects. So far the company has received more than 200 reports of birth defects, which lawsuits claim were never disclosed to “the FDA or any representative body of the United States government,” according to court documents.

In its essence it's simple: Prescription drugs cannot be promoted by drug marketers for off-label purposes. Zofran was never approved to treat nausea in pregnant women. GlaxoSmithKline promoted Zofran for this off-label use.


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