FDA mandates warnings for 2 RSV vaccines

The FDA has mandated updated safety labeling for two respiratory syncytial virus vaccines, Pfizer’s Abrysvo and GlaxoSmithKline’s Arexvy, following the identification of an increased risk of Guillan-Barré syndrome. 

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The warning follows results from postmarketing observational studies that suggested a higher incidence of GBS within 42 days after vaccination, according to a Jan. 7 news release f. 

GBS is a rare neurological disorder that causes weakened muscles and, in severe cases, paralysis due to immune system damage to nerve cells. 

The FDA has recommended that healthcare professionals monitor patients for signs of GBS following vaccination. Both vaccine manufacturers are following events and effects.

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