By Adam W. Pittman on July 1, 2015
What do consumers need to know about the history of Zofran use in the U.S.? Here are some key dates:
Zofran has been on the market since January 1991, when the U.S. Food and Drug Administration approved manufacturer Glaxo Wellcome’s new drug to treat nausea and vomiting caused by chemotherapy treatments.
Nearly 25 years later, Zofran and its generic counterpart are under fire, with lawsuits being filed against the drug maker accusing it of causing birth defects in babies born to mothers who used the drug and also heart ailments in patients who take it.
Here’s a timetable of Zofran.
Mid 1980s – Zofran is developed in London and granted its first U.S. patent in June 1988.
January 1991 – The U.S. Food and Drug Administration approves the use of Zofran in the United States by cancer patients to fight nausea symptoms.
January 1993 – The FDA approves the sale of the first pill form of Zofran in the U.S.
January 1997 – Glaxo Wellcome receives FDA approval to sell larger dosages of Zofran
March 1999 – The FDA issues a warning letter to Glaxo Wellcome claiming the company is improperly marketing Zofran and accusing the manufacturer of failing to warn consumers about the drug’s potential adverse side effects.
December 2006 – Glaxo Wellcome receives FDA approval to begin selling generic versions of Zofran.
August 2011 – In response to consumer complaints, the drug manufacturer now known as GlaxoSmithKline following a merger begins testing the heart risks of Zofran.
September 2011 – The FDA issued a drug safety alert saying use of Zofran may cause patients taking the drug to experience abnormal heart rhythms, and orders GlaxoSmithKline to conduct more extensive studies. As a result, the manufacturer revised their labels to include the FDA’s new warning about potential cardiac risks associated with taking Zofran.
June 2012 – The FDA issued a warning that a single dose of Zofran should not exceed 16mg.
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July 2012 – GlaxoSmithKline settles a lawsuit related to three of its drugs, including a case in which the FDA had accused the company of falsely promoting Zofran for off-label use by expectant mothers experiencing nausea. GlaxoSmithKline was accused of paying kickbacks to doctors who prescribed Zofran, and agreed to pay a combined 3 Billion in criminal and civil penalties, the largest ever federal and state health fraud settlement in U.S. history.
July 2012 – The FDA released a report showing preliminary results of Glaxo’s September 2011 study showed that the larger 32mg dose of Zofran could cause fatal heart rhythms.
December 2012 – The FDA reported that the 32mg dose of Zofran and its generic versions were being recalled. It also repeated the June 2012 FDA warning that Zofran should not be used in doses exceeding 16mg.
August 2013: During the International Society of Pharmacoepidemiology meeting, two conflicting papers related to use of Zofran were released. One paper citing a Dutch study found that Zofran taken during pregnancy did not significantly increase the risk of birth defects in newborns. A second paper that covered a much larger group of pregnant women and was done over more years came to dramatically different finding, claiming that use of Zofran doubled the risk of heart defects and other issues in babies born to women who took the drug during their first trimester.