GlaxoSmithKline’s vaccine cash cow Shingrix has a new safety warning on its label, although regulators still maintain the shot’s benefits outweigh risks.
Wednesday, the FDA alerted the public that it has added to the “warnings and precautions” section of the shingles vaccine’s label language about an increased risk for a rare neuro autoimmune disorder called Guillain-Barré Syndrome (GBS).
The update came after a post-marketing observational study by federal health agencies noted the risk during the 42 days following vaccination with Shingrix. The FDA stressed that “available evidence is insufficient to establish a causal relationship,” and that the “benefits of vaccination with Shingrix continue to outweigh its risks.”
