Put a WARNING LABEL ON NON FDA approved drug ZOFRAN/ONDANSETRON for PREGNANT WOMEN.

Put a WARNING LABEL ON NON FDA approved drug ZOFRAN/ONDANSETRON for PREGNANT WOMEN.

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Gaia Brigit started this petition to #FDAapproveddrugsforbabies

 “Ondansetron is not approved for use in pregnancy and is increasingly being prescribed for nausea and vomiting in pregnancy and hyperemesis gravidarum. Several recent lawsuits have highlighted the possibility that ondansetron may cause congenital malformations” (Campbell 2018).

 “Although it was not approved for use during pregnancy, Zofran quickly became the top-selling morning sickness drug in the United States in the 1990s. Concerned that GlaxoSmithKline was marketing the drug in a false or misleading manner, the FDA issued a warning letter in March 1999, ordering the company to cease distribution of its promotional materials because they failed to note risks associated with Zofran.

In 2003, two former employees of GlaxoSmithKline claimed the company promoted the off-label use of Zofran for morning sickness. The Justice Department took the drug maker to court in 2011, and GlaxoSmithKline agreed to pay the government $3 billion to settle the agency’s claims related to Zofran and other drugs. As of March 2019, this is still the largest settlement for alleged drug marketing violations in U.S. history.” (Weyant 2019)

Until we can scientifically prove with multiple valid and peer reviewed studies, that this is a safe drug that will not cause birth defects. Label every packet! Families deserve information and choice regarding the medication they consume during pregnancy.

It is understood that Zofran may be superior in terms of fighting nausea during pregnancy. As such GSK (GlaxoSmithKline) should be a lot more motivated to get the drug approved by the FDA considering how much they make of the drug.

A strict warning label needs to be issued on all packets, until it is approved like other front-line pregnancy anti-nausea drugs, to avoid any potential repeats of the Thalidomide Crisis.

References;

Campbell, S, Chari, R, Lavecchia, M, Ross, S 2018, ‘Ondansetron in Pregnancy and the Risk of Congenital Malformations: A Systematic Review’, J Obstet Gynaecology , vol.40, no.7, pp.910-918.

Weyant, C 2019, Zofran Lawsuits, Consumer Safety, viewed 28 Feb 2019, <https://www.consumersafety.org/legal/zofran-lawsuit/>

The United States Department of Justice 2012, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data; Largest healthcare fraud settlement in in U.S history, The United States Department of Justice, viewed 28 Feb 2019, <https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report>

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