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Zofran Archives

Lawsuit allegations contend drugmaker knew of Zofran risks

A recent lawsuit filed in a federal court in Philadelphia alleges that the maker of the prescription drug Zofran knew about the risks and potential side effects of the drug but did not warn patients. The suit alleges that the manufacturer of Zofran knew of risks to unborn fetuses but failed to adequately warn pregnant mothers who were using the drug to treat symptoms of nausea associated with pregnancy.

New Study Highlights Flaws of Zofran Study Results

A recent study by Gideon Koren, M.D., from the University of Toronto Department of Pediatrics provides a review of assorted literature related to Zofran use and the development of birth defects. Crucially, Dr. Koren cites problems with a 2013 study conducted by Pasternak that found no statistically significant relationship between a mother's use of Zofran and birth defects.

Illegal Actions Used in Promoting Zofran

Zofran is a prescription medication manufactured by GlaxoSmithKline (GSK) that was originally approved by the FDA in 1991 to treat chemotherapy induced nausea and vomiting. Since its introduction into the market, Zofran has become a common prescription used by pregnant women in the first trimester to quell the side effects of morning sickness. However, the use of Zofran in pregnant women was not approved by the FDA and there was never adequate information about the drug's safety to indicate Zofran could be used safely in pregnant women.

Zofran Use Linked to Birth Defects

The anti-nausea medication Zofran has recently been linked to multiple birth defects. Zofran is a powerful drug developed by drug manufacturer GlaxoSmithKline (GSK) to treat chemotherapy related nausea. The drug was originally approved in 1991 for use in cancer patients who required chemo or radiation. While the drug was designed and approved to treat nausea in cancer patients, the drug has been marketed as an effective and safe treatment for pregnancy related nausea and vomiting. In 1995, oral doses of Zofran were approved for vomiting and nausea in post operative patients.

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