Shingrix Label Updated Due to Risk of Rare Autoimmune Syndrome

March 25, 2021 – The U.S. FDA is requiring an update to the prescribing information for GlaxoSmithKline’s Shingrix® (zoster vaccine recombinant, adjuvanted) under the “warnings and precautions” section. The label now indicates that there may be a risk of Guillain-Barre syndrome (GBS) associated with the use of Shingrix.

According to the FDA, “available evidence is insufficient to establish a causal relationship” between receiving Shingrix and developing GBS. The agency believes that the clinical benefit of Shingrix continues to outweigh potential risks to patients.

First FDA approved in 2017, Shingrix is indicated to prevent herpes zoster (shingles) in adults who are at least 50 years of age. Shingles is a painful manifestation of infection with the same virus that causes chickenpox. It most often occurs in older adults who have previously had chickenpox, when the virus reactivates after lying dormant in the brain and spinal cord. While shingles is usually a brief illness, it can lead to long term complications such as chronic nerve pain.

GBS is a rare, life-threatening autoimmune disorder in which the immune system attacks nerve cells. It can occur following an infection, including infection with the virus that causes shingles and chickenpox.