E-DRUG: Rotavirus vaccine withdrawn
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Wyeth Lederle Vaccines Voluntarily Withdraws from the Market Its
Rotavirus Vaccine Rotashield�
Madison, N.J.,USA. October 15, 1999 -- Wyeth Lederle Vaccines, a
division of American Home Products Corporation (NYSE:AHP), announced
today that it has withdrawn its RotaShield� (rotavirus vaccine) from the
market and has requested the immediate return of all doses of the
vaccine.
On July 16, 1999, Wyeth Lederle Vaccines temporarily suspended further
distribution and administration of RotaShield until more data on the
potential association between vaccine administration and intussusception
became available. That action was taken in consultation with the Food
and Drug Administration (FDA) following a recommendation from the
Centers for Disease Control and Prevention (CDC) to postpone
administration because of reports to the Vaccine Adverse Events
Reporting System (VAERS) of a possible association between the use of
RotaShield and the development of intussusception.
At that time, it was hoped that conclusive data would become available
before the 1999-2000 rotavirus season. The Company has evaluated the
additional cases of intussusception reported to VAERS as well as
preliminary data from the ongoing epidemiological studies conducted by
CDC; these data will be publicly discussed at the upcoming Advisory
Committee on Immunization Practices (ACIP) meeting on October 22, 1999.
These data continue to suggest a temporal association between the use of
RotaShield and the development of intussusception. While additional
studies are planned or in progress to better understand this
relationship, the Company believes that the use of RotaShield should not
be resumed during the upcoming rotavirus season.
Therefore, Wyeth Lederle Vaccines believes it is in the best interest of
the public and our customers for the company to withdraw all remaining
supplies of the vaccine.
It is important to note that available data do not indicate an ongoing
risk to children given RotaShield in the past.
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