New FDA Rule Requires Drug Company To Replace Current Simple Pregnancy Category Designation With A Summary Of The Risks Of Using Zofran During Pregnancy
SUMMARY: Starting earlier this year drug injury products liability lawsuits alleging birth defects caused by the use of Zofran (ondansetron) during pregnancy for so-called “morning sickness” have been filed against the pharmaceutical company GlaxoSmithKline (also known as GSK or Glaxo).
In December 2014 the FDA issued a new regulatory rule that seems to require GlaxoSmithKline in the next couple of months to make an important decision which may impact the Zofran lawsuits, those already filed and those that will be filed in the future.
In particular, it seems that Glaxo will need to decide what, if anything, it will disclose, i.e., admits to know, as regards the association between Zofran and birth defects such as congenital heart defects and cleft palate or lip.
It will be interesting to check those Zofran drug label documents in a couple of months from now to see what revisions have been made by Glaxo to conform to this new FDA rule.
And it would not be a surprise if just how those Zofran label changes were made had something to do with the current Zofran – birth defects lawsuits.[Read this article in full at original source]
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