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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