ALERT ISSUED FOR SANOFI-AVENTIS' MENACTRA
The FDA and the Centers for Disease Control and Prevention have issued a health
alert after five people who received sanofi-aventis' meningitis vaccine Menactra
developed a serious nerve disorder.
Five patients, 17 to 18 years old, developed Guillane Barre Syndrome (GBS) two
to four weeks after receiving the vaccine, the agencies said recently. GBS causes
increasing weakness in the arms and legs and can require hospitalization.
"It is not known yet whether these cases were caused by the vaccine or
are coincidental," the FDA and CDC said in a release.
Sanofi-aventis noted in a statement that "no casual relationship has been
established between Menactra vaccination and GBS, and there remain several possible
explanations for the reported cases of GBS." Premarket studies conducted
by sanofi-aventis of more than 7,000 recipients of Menactra showed no GBS cases.
The scare isn't expected to have too much of an impact on sanofi-aventis, a
CM-CIC analyst reportedly said, citing the fact that thousands of patients screened
before the drug hit the market showed no signs of the disease
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