InvestorsHub Logo
Followers 59
Posts 18522
Boards Moderated 0
Alias Born 11/29/2006

Re: None

Wednesday, 01/25/2017 1:21:23 PM

Wednesday, January 25, 2017 1:21:23 PM

Post# of 2104
Industry news - ouch

Biogen's Tecfidera labeling updated to reflect liver injury warning According to a page on the FDA's website, on January 19, the labeling for Biogen's Tecfidera was updated to reflect a new warnings and precautions statement related to liver injury. The update prescribing information states: "Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with TECFIDERA. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation...Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected." Reference Link

Read more at:
http://thefly.com/landingPageNews.php?id=2493964