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Lawsuit Against GlaxoSmithKline Alleges Child’s Heart Defect Caused by Zofran Taken During Pregnancy

Filed October 5th, 2015 F.A. Kelley

In a lawsuit filed last week against GlaxoSmithKline (GSK), a couple from Alameda County, California alleges their daughter’s heart defect was a result of the mother being prescribed GSK’s anti-nausea drug Zofran (ondansetron) during the pregnancy.

Zofran is used to prevent nausea and vomiting caused by chemotherapy and radiation therapy and is also used to prevent and treat nausea and vomiting after surgery. It works by blocking serotonin, a natural substance that causes vomiting, WebMD explains.

The child at the center of the lawsuit was born in 2007 with severe congenital heart malformations. She had to undergo numerous examinations in her first years of life and at age four she had surgery to correct the defect. The lawsuit alleges that the heart defect would not have occurred if GlaxoSmithKline had not concealed the risks of taking Zofran during pregnancy. The parents said, “it has been a long struggle to address damage to her heart that we believe was caused by Zofran.” They filed the lawsuit, in part, to raise awareness of the dangers of Zofran.

The Food and Drug Administration (FDA) approved Zofran for the treatment of the severe nausea that can be caused by chemotherapy or radiation treatments in cancer patients and nausea and vomiting in surgical patients. But GSK marketed Zofran “off-label” as a safe and effective treatment for nausea and vomiting many women experience during pregnancy—morning sickness.

In 2012, GSK pled guilty to criminal charges filed by the U.S. Department of Justice for its off-label promotion of certain prescription drugs, including Zofran, for uses never approved by the FDA. Despite the GSK guilty plea, Zofran continues to be widely prescribed to pregnant women to treat morning sickness, although the FDA has not approved this use.

“Despite having received hundreds of reports of birth defects associated with Zofran and continuing strong sales to pregnant women, GSK has not performed any clinical studies on the safety or efficacy of Zofran for treating morning sickness,” according to a news release by attorneys representing the girl’s family. One of the attorneys said GSK has not changed Zofran’s label to warn doctors and pregnant women that epidemiological studies report an increased risk of birth defects in infants exposed to Zofran during pregnancy. Recent studies report that when a woman takes Zofran during pregnancy, she has more than double the risk of having a baby with a congenital heart defect compared to a mother who did not take Zofran during pregnancy. In addition to the risk of heart defects, parents have filed lawsuits alleging Zofran caused their child’s cleft lip or cleft palate.

The California family’s lawsuit—filed in federal court in San Francisco—claims negligence, misrepresentation, concealment, breach of warranty, and violations of California law. The parents seek both compensatory and punitive damages from GSK.

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