No need to change pregnancy risk data label GlaxoSmithKline wins Zofran safety lawsuit

CompilationFan Dongdong

A few days ago, GlaxoSmithKline won a positive ruling in the Massachusetts District Court following the Zofran case closely.

GlaxoSmithKline has been defending the claim that the use of Zofran during pregnancy causes birth defects and fails to warn about the risks.

The plaintiffs in this lawsuit are hundreds of women or their children.

Zofran is a drug launched by GlaxoSmithKline in the 1990s.

However, Judge Saylor made it clear in this ruling that even assuming that GlaxoSmithKline actually did not make a complete disclosure to the FDA when Zofran was initially approved, there is no doubt that the FDA has fully understood the safety of the drug at various subsequent stages.

GlaxoSmithKline said in an e-mail statement that the company was satisfied with the judge's ruling in favor of the company, and pointed out that the court believed that the FDA had fully understood the safety of Zofran when it refused to add a warning to the Zofran label.

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