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FDA Data
Presents Controversial Views of Gardasil |
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A conservative watchdog
group, Judicial Watch, has recently published new government data of adverse
events (AEs) related to Gardasil, Merck & Co.'s vaccine against human
papillomavirus (HPV). The Food and Drug Administration (FDA) maintains data
on AEs reported by US physicians. CDC helps FDA monitor AEs.
Of the 2 million to 3 million Gardasil vaccinations US women may have
received to date, most of the 1,637 reported AEs have been minor - such as
injection site pain, itching, and dizziness. The proportion of AEs is not
considered high. FDA deemed 136 AEs serious, including seizures, and
paralysis-inducing Guillain-Barre Syndrome.
Two females died of blood clots after receiving Gardasil, but they were also
taking birth control, a known risk factor for blood clots. Also in the AE
data was a 12-year-old with a history of heart disease who died of
flu-related heart inflammation, said CDC. Of 18 pregnant women with reported
AEs, 16 miscarried, one was diagnosed with an abnormal fetus, and the
outcome was not reported for another diagnosed at high risk for fetal
defect.
Gardasil's label states it is "not recommended for use in pregnant women,"
since its use among this population has not been well-studied, said Dr.
Richard Haupt, Merck's executive director of medical affairs. At least some
of the pregnant women with pregnancy-related AEs were unaware they were
pregnant.
After five birth defects were reported during Gardasil's clinical trials,
Merck promised FDA it would compile a registry of pregnant women exposed to
the vaccine and any potential effect on pregnancy. Of more than 300 entries,
Merck said its registry had received no reports of congenital abnormality.
An FDA spokesperson, Karen Riley, said the agency is monitoring AEs closely,
but "we haven't seen anything at this point that would suggest we'd make any
changes in the product," including with respect to pregnancy. Judicial Watch
is opposed to legislative measures that would require HPV vaccinations for
pre-teen schoolgirls.
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Wall Street Journal
(05.24.07):: John Carreyrou |
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media reports on HIV/AIDS, other sexually transmitted diseases
does not constitute endorsement. The above summaries were prepared
without conducting any additional research or investigation into the
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validity or invalidity of any statements made in these summaries. This
CDC HIV/STD/TB Prevention News
Update also includes information from CDC and
other government agencies, such as background on MMWR articles, fact
sheets and announcements. |
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