EU Panel: Keeps Stance That Gardasil Benefits Outweigh Risks
Thursday January 24th, 2008 / 17h32
Edited Press Release ZURICH -(Dow Jones)- An advisory body of the European Union Thursday said it still believes benefits associated with Merkc & Co's (MRK) human papillomavirus-vaccine Gardasil outweigh the risks. The European Medicines Agency said it 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. Gardasil is a vaccine approved in the EU for the prevention of cervical cancer and other diseases caused by human papillomavirus 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. Company Web Site: http://www.emea.europa.eu -Zurich Bureau, Dow Jones Newswires; +41 43 443 8040; zurichdjnews@dowjones.com
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