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EMEA Statement on the Safety of Gardasil LONDON, UK -- January 24, 2008 -- The European Medicines Agency (EMEA) has received reports of deaths in women who had previously received Gardasil® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], 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. SOURCE: European Medicines Agency E-mail this page to a friend or colleague! To print, use this version