2008 FDA Closing Statement on Gardasil

Gardasil doseOctober 2008 – The 2008 FDA Closing Statement on Gardasil, “Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18” states that 73.3% of the healthy girls who participated in the clinical trials on Gardasil developed ‘new medical conditions’. 14 girls died during the trials.

 

 

 

The list below highlights some of the ‘New Medical Conditions’ reported in the paper.

  • Blood & Lymphatic System Disorders 2.9% = 1 in 34
  • Gastrointestinal Disorders 13.4% = 1 in 7
  • General & Administration Site Conditions 3.8% = 1 in 33
  • Immune System Disorders 2.4% =1 in 50
  • Infections & Infestations 52.9% = 1 in 2
  • Injury, Poisoning, & Procedural Complications 8.0% =1 in 12
  • Investigations 11.8% =1 in 9
  • Musculoskeletal & Connective Tissue Disorders 6.8% =1 in 14
  • Nervous System Disorders 9.4% = 1 in 10
  • Pregnancy, Puerperium & Perinatal Conditions 2.0% = 1 in 50
  • Psychiatric Disorders 4.4% =1 in 22
  • Renal Disorders 2.7% =1 in 37
  • Reproductive & Brest Disorders 24.8 % = 1 in 14
  • Respiratory, Thoracic & Mediastinal Disorders 5.5% = 1 in 18

 

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.