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EMEA Statement On The Safety Of Gardasil, Europe
The European Medicines Agency (EMEA) has received reports of deaths in
women who had previously received Gardasil, including two reports
concerning the sudden and unexpected deaths of two young women in the
European Union (EU). Gardasil is a vaccine approved in the EU for the
prevention of cervical cancer and other diseases caused by human
papillomavirus (HPV) types 6, 11, 16 and 18. It is estimated that about
1.5 million patients have been vaccinated with this HPV vaccine in
Europe.
The two European cases were reported as part of the continuous
monitoring of the safety of medicines. One of the cases occurred in
Austria and the other in Germany. In both cases, the cause of death
could not be identified. No causal relationship has been established
between the deaths of the young women and the administration of
Gardasil.
On the basis of the currently available evidence, the EMEA's Committee
for Medicinal Products for Human Use (CHMP) is of the opinion that the
benefits of Gardasil continue to outweigh its risks and that no changes
to its product information are necessary.
The EMEA will continue to closely monitor the safety of Gardasil and
take appropriate actions should new information emerge that has an
impact on the benefit-risk profile of Gardasil.
Notes:
1. The approved indication in the EU for Gardasil is: "Gardasil is a
vaccine for the prevention of high-grade cervical dysplasia (CIN 2/3),
cervical carcinoma, high-grade vulvar dysplastic lesions (VIN 2/3), and
external genital warts (condyloma acuminata) causally related to Human
Papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on
the demonstration of efficacy of Gardasil in adult females 16 to 26
years of age and on the demonstration of immunogenicity of Gardasil in
9- to 15-year old children and adolescents. Protective efficacy has not
been evaluated in males. The use of Gardasil should be in accordance
with official recommendations." For more information on Gardasil, please
see here.
2. HPV types 6, 11, 16 and 18 vaccine is also marketed in the EU as
Silgard. For more information on Silgard, please see here.
European Medicines Agency
View drug information on Gardasil.
EMEA declaraþie cu privire la siguranþa Gardasil, Europa - EMEA Statement On The Safety Of Gardasil, Europe - articole medicale engleza - startsanatate