A Boston woman is suing GlaxoSmithKline (GSK), alleging the drug maker marketed its anti-nausea drug Zofran off-label as a morning sickness relief while concealing its knowledge that ingestion of the drug by pregnant women can cause serious birth defects.

The Zofran lawsuit, filed in the U.S. District Court for the District of Massachusetts, claims that the plaintiff was prescribed Zofran to alleviate morning sickness symptoms in 2000. Her daughter, born that year, was subsequently diagnosed with nine birth defects, including three congenital heart defects: aortic arch hypoplasia, right ventricular hypertension and atrial septal defect.

The plaintiff claims that these birth defects were caused by prenatal exposure to Zofran. She says that her daughter has been forced to “undergo ten surgeries to try and correct her numerous congenital abnormalities” and that these “birth defects impair her [daughter’s] development and enjoyment of a normal life at home and at school due to substantial developmental delays.”

Studies Suggest Link Between Zofran and Pregnancy Risks

Multiple epidemiological studies have now found an association between prenatal exposure to Zofran and increased risks of birth defects. Reviewing hundreds of thousands of birth records, teams in Europe found significant increases in the rate of congenital heart defects among babies exposed to Zofran before birth. In the United States, researchers at Harvard and Boston University found that women prescribed Zofran’s active ingredient (ondansetron) were more than twice as likely to deliver babies with cleft palate.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran Birth Defects Allegations

Ondansetron, manufactured by GlaxoSmithKline under the brand name Zofran, is approved by the FDA to treat severe nausea and vomiting only in patients undergoing chemotherapy, radiotherapy, or surgical anesthesia. It has never been approved as a treatment for “morning sickness,” the nausea and vomiting that commonly accompanies early pregnancy. Nor has GlaxoSmithKline conducted clinical trials to determine the drug’s effects in pregnant women, trials that are required before a medication can be approved for use specifically during pregnancy.

Notwithstanding these facts or medical studies, Zofran has seen a surge in prescription sales, and doctors across the globe have made it a leading, albeit “off-label,” treatment for morning sickness.

Prescribing drugs for unapproved, or “off-label” uses is a common practice, and one not regulated by the FDA. But under provisions outlined in the Federal Food, Drug & Cosmetic Act, pharmaceutical manufacturers are prohibited from promoting drugs for any uses not approved by the FDA.

Zofran Birth Defect Lawsuits

Zofran is not approved for use in pregnant women and many parents have begun to come forward. To date, at least seven families have filed Zofran lawsuits against GlaxoSmithKline. These parents say that they were prescribed Zofran as a morning sickness treatment, and that the drug caused their children to be born with birth defects.

Over the coming months and years, as more families learn about the link between the anti-nausea drug and birth defects, it is expected that more Zofran lawsuits will be filed by parents across the country.