WHO Drug Information Vol. 20, No. 4, 2006 - World Health ...

WHO Drug Information Vol 20, No. 4, 2006 Safety and Efficacy Issues
References
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the Child, International League against
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drugs. BMJ 2006;333:615–616
4. Morrow JI, Russell A, Gutherie E, Parsons
L, Robertson I, Waddell R, et al. Malformation
risks of anti-epileptic drugs in pregnancy: a
prospective study from the UK Epilepsy and
Pregnancy Register. J Neurol Neurosurg
Psychiatry 2006;77: 193–8.
5. Vajda FJ, O’Brien TJ, Hitchcock A, Graham
J, Cook M, Lauder C, et al. Critical relationship
between sodium valproate dose and human
teratogenicity: results of the Australian register
of anti-epileptic drugs in pregnancy. J Clin
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rate of major malformations in offspring
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Neurology 2005;64: 961–5.
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Meningococcal vaccine and
Guillain Barré syndrome
United States of America — The Food
and Drug Administration (FDA) and
Centers for disease Control ( CDC) have
updated an October 2005 alert to consumers
and health care providers regarding
reports of Guillain Barré syndrome
(GBS) following administration of Meningococcal
Conjugate Vaccine A, C, Y, and
W135 (Menactra®).
To date, a total of 15 confirmed cases of
GBS among individuals 11–19 years of
age occurring within six weeks of vaccination
with Menactra® have been reported
to the Vaccine Adverse Event
Reporting System (VAERS). Two additional
cases have been confirmed in
persons 20 years of age and older. At
this time, CDC and FDA cannot determine
with certainty whether Menactra®
does increase the risk of GBS in persons
who receive the vaccine and, if so, to
what degree.
In October 2005, reports indicating a
possible association between Guillain-
Barré Syndrome (GBS) and meningococcal
conjugate vaccine (MCV4)
(Menactra ® ) were made to the Vaccine
Adverse Event Reporting System
(VAERS). GBS is a serious neurologic
disorder involving inflammatory demyelination
of the peripheral nerves. During
March 2005—February 2006, eight
confirmed cases had occurred within 6
weeks (i.e., the time window of elevated
risk noted for GBS after administration of
other vaccines) after MCV4 vaccination.
Nine additional GBS cases were reported
to VAERS during March—September
2006. Although data suggest a small
increased risk for GBS after MCV4
vaccination, the inherent limitations of
VAERS and the uncertainty regarding
background incidence rates for GBS
require that these findings be viewed with
caution.
References
1. FDA MedWatch alert: Menactra® (Meningococcal
Conjugate Vaccine A, C, Y, and W135):
Posted 10/23/2006. http://www.fda.gov
2. FDA News, P05-66, 30 September 2005.
3. VAERS at http://www.vaers.hhs.gov
4. FDA and CDC Update Information on
Menactra® Meningococcal Vaccine and
Guillain Barre Syndrome. 20 October 2006 at
http://www.fda.gov/bbs/topics/news/2005/
new01238.html
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