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 ...
Hosted on MSN6d
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 ...
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 ...
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 ...
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.
cidrap.umn6d
FDA requires Guillain-Barre label warnings for 2 RSV vaccines
The change was prompted by postmarketing observational studies that suggest an increased risk of GBS within 42 days of ...
Guillain-Barre Syndrome explained as 2 RSV vaccines flag neurological 'risk'
As for GBS itself, this neurological ailment can be severe, attacking nerves and warranting hospitalisation for weeks or ...
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 ...
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 ...