| Brand Name: Gardasil |
Generic Name: Human Papillomavirus Vaccine |
| Drug Category: Vaccine |
Litigation Alert Level: High |
| Approved Use: Indicated for: Girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine: • Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18 • Genital warts (condyloma acuminata) caused by HPV types 6 and 11 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18: • Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS) • Cervical intraepithelial neoplasia (CIN) grade 1 • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3 • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3 • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 Indicated for: Boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine: • Anal cancer caused by HPV types 16 and 18 • Genital warts (condyloma acuminata) caused by HPV types 6 and 11 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18: • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. Note: Merck has not published any safety data for simultaneous Gardasil vaccination with any other vaccine except hepatitis B vaccine (recombinant), Menactra or Adacel. Source: http://tinyurl.com/2pq89a This drug has been approved for use by Males and Females between the ages of 9 Years Old and 26 Years Old. The Maximum Usage Duration is 6 Months. |
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| Off Label Use: • Use in patients under 9 years of age. Source: http://tinyurl.com/2pq89a • Use in patients over 26 years of age. Source: http://tinyurl.com/2pq89a • Use for prevention of oral cancer. Source: http://tinyurl.com/3mnnj5c • Treatment of cutaneous warts. Source: http://tinyurl.com/3sqly5n |
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| Adverse Events: Reports of facial paralysis and Guillain-Barre Syndrome after Gardasil injection. Source: http://tinyurl.com/3t8y8ax As of June 22, 2011, VAERS received a total of 18,727 reports of adverse events following Gardasil vaccination: 17,958 reports among females and 346 reports for males. Reports including deaths, spontaneous abortions, Guillain-Barre Syndrome, fainting and blood clots. Source: http://tinyurl.com/y9qo8mw As of June 22, 2011 there have been a total 68 VAERS reports of death among patients who have received the Gardasil vaccine. Source: http://tinyurl.com/y9qo8mw According to documents released from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act (FOIA) 26 new deaths were reported to the government following HPV vaccination between September 1, 2010 and September 15, 2011 (26 reported deaths of young, previously healthy, girls after Gardasil vaccination in just one year). Source: http://tinyurl.com/6mmouhr Per the the Vaccines and Related Biological Products Advisory Committee (VRBPAC) when Gardasil is administered to a woman with a dormant or harmless form of HPV, the virus can become activated, increasing the likelihood of precancerous lesions developing by 44.6 percent. Source: http://tinyurl.com/3ozg7f8 According to a recent study Gardasil was found to reduce HPV-16 infections a mere 0.6% in vaccinated women versus unvaccinated women. At the same time, other high-risk (carcinogenic) HPV infections were diagnosed in vaccinated women 2.6% to 6.2% more frequently than in the unvaccinated women. Source: http://tinyurl.com/cz4xqsm Reports of seizures, strokes, dizziness, fatigue, weakness, headaches, stomach pains, vomiting, muscle pain and weakness, joint pain, auto-immune problems, chest pains, hair loss, appetite loss, personality changes, insomnia, hand/leg tremors, arm/leg weakness, shortness of breath, heart problems, paralysis, itching, rashes, swelling, aching muscles,pelvic pain, nerve pain, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea and temporary vision/hearing loss. Source: http://tinyurl.com/yc3mpmp |
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| Litigation: Class actions and individual lawsuits filed for death, blood clots, birth defects and paralysis occurring after administration of Gardasil vaccine. Source: http://tinyurl.com/3v39283 http://tinyurl.com/35nsmf6 |
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