Glax­o­SmithK­line scores a win in Zofran case af­ter FDA re­peat­ed­ly said preg­nan­cy risk da­ta did not re­quire la­bel changes

GSK did suf­fi­cient­ly warn the FDA re­gard­ing birth de­fects tied to its nau­sea drug Zofran (on­dansetron), and be­cause the FDA de­cid­ed not to up­date the drug’s la­bel, GSK won a pos­i­tive de­ci­sion in a close­ly-watched case from the US Dis­trict Court of Mass­a­chu­setts on Tues­day.

The de­ci­sion makes clear that GSK and No­var­tis (the cur­rent own­er of Zofran as of 2015) in­formed the FDA of the avail­able da­ta on the safe­ty of Zofran, but from about 2010 un­til ear­li­er this year, the FDA re­ject­ed any la­bel changes that would’ve warned that us­ing the drug dur­ing preg­nan­cy could cause harm to the fe­tus. The CDC cur­rent­ly runs a web­site not­ing that, “Tak­ing On­dansetron Dur­ing Preg­nan­cy Does Not Ap­pear to In­crease Risk For Birth De­fects.”

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