|FOOD AND DRUG
FOR IMMEDIATE RELEASE T99-6
Consumer Media: 888-Info-FDA
January 29, 1999
RECALL OF ONE LOT OF TRIPEDIA BECAUSE OF SUBPOTENT DIPHTHERIA
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The FDA is announcing that one lot of Tripedia,
(lot number 0916490) a U.S. licensed vaccine that immunizes children against diphtheria,
tetanus and pertussis, has been voluntarily recalled because the diphtheria component of
the vaccine was recently found to be subpotent. The lot was distributed nationally between
February and June, 1998, by Pasteur Merieux Connaught of Swiftwater, Pa. The subpotent lot
was discovered by routine testing of retained samples by the company.
No problem exists with the potency of the tetanus
and pertussis components of this lot, and no adverse reactions related to the subpotent
diphtheria component would be expected. However, health professionals may advise parents
that some children should receive a supplemental vaccine dose.
Because diphtheria is very rare in the United
States, (largely due to the routine immunization of children,) the risk to most children
who received the subpotent lot is extremely low. The risk may be higher for children
traveling to a country with a higher risk for the disease. For some of these children who
will be traveling outside the U.S., supplemental immunization may be needed.
In addition, any child who received a dose from
the subpotent lot of Tripedia should receive subsequent scheduled doses on a regular,
timely basis to ensure the optimum level of immunity against diphtheria.
Diphtheria is a serious disease usually spread
from the respiratory tract that causes a thick covering in the back of the throat that can
lead to breathing problems. Heart problems and other serious complications are also
possible. From 1980 through 1996, only 43 cases of diphtheria were reported in the United
Diphtheria occurs worldwide, but clinical cases
are more prevalent in temperate zones during colder months (winter and spring). Risk to
travelers increases with prolonged travel, extensive contact with children, or exposure to
less than optimal hygiene conditions. Individuals who will be traveling abroad and who may
be affected by this recall should contact their health provider. Information from the
Centers for Disease Control and Prevention (CDC) is available on their website at
Five doses of a vaccine containing a diphtheria
component are recommended for preschool aged children in the U.S. and provide optimal
protection against diphtheria. Currently, most children are vaccinated against diphtheria
with a combination vaccination such as Tripedia, which includes components that protect
against tetanus and pertussis, in addition to diphtheria. Tripedia is given at 2, 4, and 6
months of age, with additional doses for added protection at 12-18 months and before going
to school. The first three doses are considered the primary series of vaccinations.
If parents need further information they should
contact their physicians. FDA and CDC will be advising physicians about further, more
specific, recommendations for supplemental immunization of children who have received
doses of the subpotent lot. Health professionals can also call Pasteur Merieux Connaught
at 1-800-325-7709 for further information.
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public on subjects of current interest. Talk Papers are subject to change as more
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