GBS warning for Menactra issued
A total of 15 cases of Guillain-Barré syndrome (GBS) following the administration of meningococcal conjugate vaccine A, C, Y, and W135 (Menactra, Sanofi-Aventis) have been reported to the Vaccine Adverse Event Reporting System (VAERS), leading the FDA and CDC to issue an alert to consumers and healthcare providers explaining the risk. The documented cases have occurred in individuals 11 to 19 years of age within six months of receiving the vaccine. Two additional cases were reported in persons 20 years of age and older. The agencies report the findings could suggest a small increased risk of GBS following inoculation with Menactra; however, at this time they cannot determine with certainty whether the vaccine increases the risk or to what degree. The FDA asks that anyone with knowledge of possible cases to report them to VAERS at
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
