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The History of Zofran

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The History of Zofran
03.02.2016 News

Zofran is one of the most popular medications in the United States, but the CDC’s National Center on Birth Defects and Developmental Disabilities found that Zofran taken during the first trimester of pregnancy doubles the risk of a cleft palate birth defect. So how did such a dangerous medication achieve such popularity?

The Development of Zofran

In the mid 1980s, GlaxoSmithKline (GSK) developed Zofran in the United Kingdom to prevent nausea and vomiting after general surgery and cancer treatment. It quickly gained traction for off-label uses, particularly for treating morning sickness in pregnant women. By 1991, the FDA had approved the medication for prescription in the United States. In only 15 years Zofran became the 20th highest-selling brand name drug in the country, reaping $1.3 billion in sales in 2006 alone. As Zofran rose in popularity, medical data linking the medication to birth defects began to surface.

Fraud Allegations

In 2012, GlaxoSmithKline pled guilty to fraud allegations and failure to report safety data. The criminal charges were linked to several of their top selling medications, including Zofran. Despite its widespread use to treat nausea and vomiting in pregnancy, the warning label for Zofran did not include information concerning the possible side effects for pregnant women. GSK eventually pled guilty to promoting the medication for off-label use to treat morning sickness. The company was fined $3 billion, but considering the revenue from Zofran alone, this was nothing more than a slap on the wrist.

In 2013 a Denmark study found a 30% increased risk of a major birth defect in children whose mother took Zofran during pregnancy. After the publication of this study, many additional medical tests were undertaken and concluded with the same results: Zofran increases the risk of birth defects if taken while pregnant. Zofran birth defects include cleft palates and lips, club feet, heart defects, and more. The FDA has received over 475 reports of birth defects from Zofran.

Blizzard & Nabers Zofran Birth Defects Lawyers

If you or someone you know took Zofran during pregnancy, and a child was born with birth defects including a cleft palate and/or a heart defect, you and the affected child may be entitled to financial compensation. Taking on pharmaceutical companies is an intimidating prospect, but the attorneys of Blizzard & Nabers have years of experience successfully handling a wide range of medical device and pharmaceutical side effects cases. Our trial lawyers have served in national litigation leadership positions involving cases where medications taken during pregnancy have caused birth defects. We have the experience you need on your side to make the best decision for your family. Contact us today.

 

Sources:

http://www.drugs.com/zofran.html

http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report

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