NEWSROOM
Merck Statement on GARDASIL® |
WHITEHOUSE STATION, N.J., Sept. 13, 2011 - Merck (NYSE:MRK), known as MSD outside the United States and Canada, issued the following statement on GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], Merck's vaccine to protect against certain diseases caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18. The facts about GARDASIL are clear. The efficacy and safety of GARDASIL was established in clinical trials in thousands of patients. Since its approval in 2006, the vaccine has been given to millions of girls around the world. Merck remains strongly committed to preventing cervical cancer. Leading national and international health organizations actively monitor and evaluate the HPV vaccine, and they continue to recommend its use. Just last month, the Institute of Medicine reaffirmed the safety of a number of vaccines, including HPV vaccines, and concluded, "Despite much media attention and strong opinions from many quarters, vaccines remain one of the greatest tools in the public health arsenal." Every year, approximately 12,000 women in the United States are diagnosed with cervical cancer, and most cases are caused by HPV types 16 and 18. This is why the medical community rejoiced when HPV vaccines first become widely available in 2006, and why Merck continues in its efforts to prevent cervical cancer. GARDASIL is approved for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. Important Information about GARDASIL Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider. GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal and anal cancers; cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, or anal intraepithelial neoplasia. GARDASIL has not been demonstrated to protect against disease due to HPV types not contained in the vaccine. Not all vulvar, vaginal and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal and anal cancers caused by HPV Types 16 and 18. Select safety information for GARDASIL GARDASIL is not recommended for use in pregnant women. The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising. Dosage and administration for GARDASIL About Merck Merck Forward-Looking Statement The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships, Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov). |
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GARDASIL® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA Prescribing Information and Patient Product Information for GARDASIL® are available at |
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