Like Depakote, Stavzor Can Cause Liver Failure, Usually During First 6 Months; Children Under Age 2 Are At A Higher Risk, As Are Patients with Mitochondrial Disease

Black-Box Warning Added To Stavzor Label Announced By FDA In March 2014, Almost Full Year After Similar Label Change For Depakote Hepatotoxicity

 
SUMMARY:  We are looking into why there was an apparent delay of 10 months in either (1) Noven Therapeutics adding a Hepatotoxicity Black-Box Warning to the Stavzor label, or (2) the FDA announcing this “new” Stavzor-induced liver failure increased warning.

In more detail, Stavzor, a lesser known valproic acid medication from Noven Therapeutics, LLC apparently had a so-called “Black-Box” Warning, or Boxed Warning, about Hepatotoxicity and hepatic failure, or liver failure, added to its label in March 2014. This is 10 months after a substantially identical Black Box Warning was added to Depakote, Depacon, and Depakene — also valproic acid medicines — by AbbVie Inc. (formerly Abbott) back in May 2013.

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