FDA, CDC WARN OF POSSIBLE LINK BETWEEN MENINGITIS VACCINE AND GBS

The FDA and the Centers for Disease Control and Prevention (CDC) have updated their alert on sanofi pasteur's meningococcal vaccine Menactra after additional reports surfaced of patients suffering from Guillain-Barre Syndrome (GBS) shortly after receiving the drug.

The agencies' initial alert in October 2005 reported five cases of GBS in people who had received Menactra. The Vaccine Adverse Event Reporting System (VAERS) now has found 17 confirmed cases of patients developing GBS within six weeks of receiving Menactra, according to an alert posted to the FDA's MedWatch website Oct. 23. Fifteen of the cases occurred in individuals between 11 and 19 years of age, and two in people over the age of 30.

Despite these reports, the FDA and the CDC said they cannot determine whether the Menactra vaccine increases the risk of GBS. No cases appeared in sanofi pasteur studies, involving more than 7,000 Menactra recipients, before the vaccine was licensed, according to the MedWatch alert. The agencies are not changing any recommendations for the vaccine at this time, though they continue to monitor the situation.

"Although these data suggest a small increased risk for GBS after [Menactra] vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution," the CDC said in its Oct. 20 Morbidity and Mortality Weekly Report.

GBS is a rare neurological disorder that causes weakness or numbness in the extremities. All of the individuals in the GBS cases reported to VAERS are recovering or have recovered, the agencies said.

The statement from the FDA and the CDC can be seen at www.fda.gov/cber/safety/gbs102006.htm (http://www.fda.gov/cber/safety/gbs102006.htm).