FDA adds Guil­lain-Bar­ré syn­drome warn­ing to Glax­o­SmithK­line’s shin­gles vac­cine

The FDA late Wednes­day sent out a safe­ty com­mu­ni­ca­tion to ex­plain that while Glax­o­SmithK­line’s shin­gles vac­cine Shin­grix is a safe vac­cine, it’s now added a new warn­ing to the la­bel not­ing an in­creased risk of a rare but de­bil­i­tat­ing dis­or­der known as Guil­lain-Bar­ré syn­drome (GBS).

“In a post­mar­ket­ing ob­ser­va­tion­al study, an in­creased risk of GBS was ob­served dur­ing the 42 days fol­low­ing vac­ci­na­tion with Shin­grix,” the up­dat­ed Warn­ings and Pre­cau­tions sec­tion of the la­bel now says. The FDA al­so de­ter­mined that the ben­e­fits of vac­ci­na­tion with Shin­grix con­tin­ue to out­weigh its risks.

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