Wednesday, October 19, 2011

Flashback to Gardasil

With all the reading that I have been doing about Mifepristone, I thought that it would be interesting to compare the adverse events to Gardasil, one of the HPV vaccines.

According to the April 2011 FDA report. Since September 2000 there were a total of[1]
  • About 1,520,000 women had taken mifepristone
  • 2207 Adverse Events including
    • 14 Deaths
      • 8 deaths from sepsis
      • 2 deaths from ruptured ectopic pregnancy
      • 1 case each of substance abuse/drug overdose, methadone overdose, 
      • 1 suspected homicide, 
      • 1 delayed onset of toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella)
    • 58 ectopic pregnancies
    • 339 cases of blood loss so severe that they required transfusions
    • 256 Infections
      • 48 cases of serious infections
Gardasil was approved June 2006 and as of June 2011[2],
  • 35,000,000 doses have been dispensed meaning that about half of girls 13 to 17 have received at least one dose of their three doses.[3] 
    • 18,727 Adverse Events including
      • 92% included fainting, pain, and swelling at the injection site (the arm), headache, nausea, and fever.Syncope (fainting) is common after injections and vaccinations, especially in adolescents.
      • 8% were severe adverse events that included hospitalization, permanent disability, life-threatening illness, congenital anomaly or death
      • 68 deaths
        • 54 females 
        • 3 males
        • 11 unknown gender
        • 32 deaths have been confirmed while 34 have not been confirmed, because of lack information in the report.
The Mifepristone adverse events would easily qualify as severe adverse events in the CDC research.  As with the Gardasil severe adverse events, the Mifepristone adverse events cannot be proven to have a casual relationship to the drug.  Also they are both extremely rare.  99.92% of those that take Gardasil and 99.85% of those that take Mifepristone will not have these events.  Both of these are exceptionally safe medications.  




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