FDA adds warning label to RSV vaccines Abrysvo and Arexvy about the risk for Guillain-Barré syndrome
The U.S. Food and Drug Administration now requires and has approved safety labeling changes to the prescribing information ...
infectiousdiseaseadvisor.com1d
RSV Vaccine Labeling Updated With Guillain-Barré Syndrome Warning
The prescribing information for Abrysvo ® (respiratory syncytial virus [RSV] vaccine) and Arexvy ® ( RSV vaccine, adjuvanted) has been updated to include a new warning regarding the risk of ...
FiercePharma6d
RSV vaccines from Pfizer, GSK take another hit with new FDA warning mandate
The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning ...
FDA Urges Guillain-Barré Syndrome Warning On Labels Of RSV Vaccines Abrysvo And Arexvy
The FDA has required the manufacturers of the RSV Vaccines Abrysvo and Arexvy to add a new warning to their labels about the ...
Medpage Today on MSN7d
FDA Adds Guillain-Barre Syndrome Warning to Two RSV Vaccines
Before the RSV vaccines were approved, the FDA flagged potential GBS risks with the vaccines. After approval, the CDC ...
Pfizer And GSK's RSV Vaccines Safety Labels Updated, FDA Adds Warning For Rare Neurological Disorder
FDA updates safety labels for Pfizer's Abrysvo and GSK's Arexvy RSV vaccines, citing increased Guillain-Barré syndrome risk.
Healio6d
FDA says RSV vaccines must come with Guillain-Barré warning
The FDA is adding a warning about Guillain-Barré syndrome to the respiratory syncytial virus vaccines manufactured by GSK and ...
GSK and Pfizer's RSV vaccines to carry warnings of neurological disorder risk
GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing ...
BioSpace6d
GSK, Pfizer RSV Shots Required to Carry Guillain-Barré Syndrome Warnings
A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s ...
Get Surrey5d
RSV vaccines to carry neurological disorder risk warning after new research
The study noted an increased risk of this neurological disorder in patients who had received the Arexvy and Abrysvo vaccine from each firm respectively. As a result, the agency issued a request ...
FDA adds warning to RSV shots from GSK, Pfizer
Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.
Monthly Prescribing Reference7d
RSV Vaccine Labeling Updated With Guillain-Barré Syndrome Warning
According to the FDA, the benefits of vaccination with Abrysvo and Arexvy continue to outweigh the potential risks. The prescribing information for Abrysvo ® (respiratory syncytial virus [RSV ...