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‫ققققق‬ ‫قق‬ ‫ققققققق‬ ‫قققق‬ ‫ققق‬
How To Withdraw Drug(s)
From The Market
By Dr. Mohammad AlmermeshBy Dr. Mohammad Almermesh
Sunday, April 03, 2016Sunday, April 03, 2016
‫قققق‬ ‫قققق‬
•‫قققققق‬ ‫ققققق‬ ‫ققققق‬ ‫ققققق‬ ‫قق‬ ‫قققق‬ ‫قققققق‬ ‫ققققققق‬
‫قققققق‬ ‫ققق‬ ‫قققق‬ ‫قق‬ ‫ققققق‬
•‫قق‬ ‫قققق‬ ‫قق‬ ‫ققققققققق‬ ‫قق‬ ‫قققققق‬ ‫قققققق‬ ‫ققققق‬
‫قققققققق‬ ‫ققققققق‬
•‫ققققق‬ ‫ققق‬ ‫قققق‬ ‫قققققق‬ ‫ققققق‬ ‫ققق‬ ‫ققق‬ ‫قققق‬
•‫ق‬ ‫قققققققق‬ ‫قق‬ ‫ققققق‬ ‫قققققق‬ ‫ققققققق‬ ‫ققق‬ ‫قققق‬ ‫قققق‬
‫قققققق‬ ‫ققق‬ ‫ققققققق‬ ‫ققق‬ ‫قققققق‬ ‫قق‬ ‫قققققق‬ ‫ق‬ ‫ققققق‬
•‫ق‬ ‫ققققق‬ ‫ققققققق‬ ‫ققققق‬ ‫قق‬ ‫قققققققق‬ ‫قققققق‬ ‫ققق‬ ‫ققققق‬
‫ققق‬ ‫ققققققق‬ ‫قققققققق‬‫قق‬ ‫ققققققق‬ ‫قققققق‬ ‫قققق‬ ‫)ققق‬
(‫ققققق‬ ‫قق‬ ‫ققققققق‬ ‫ققق‬ ‫ققققق‬ ‫ققق‬
•‫ققق‬ ‫قق‬ ‫قق‬ ‫ققققققق‬ ‫ققققققق‬ ‫قققققققق‬ ‫قققق‬ ‫قققققق‬
‫قققققققق‬ ‫قق‬ ‫قققققققق‬ ‫ققق‬ ‫قق‬ ‫ققققق‬ ‫ققققق‬ ‫قق‬ ‫ققققق‬
‫ققق‬ ‫قققققققق‬FDA‫ققق‬ ‫قققققق‬ ‫قق‬EMA‫ققققققق‬ ‫قق‬
))A systemic reviewA systemic review
462 Drugswithdrawn from market
(1953- 2013)
Most common reason is
Hepatotoxicity
Immune-mediated Reactions
72% anecdotal
(verbal) reports
9.34 %
withdrawn
worldwide
39 % were
withdrawn in
one country only
less likely in Africa
Responsible for 30%
of withdrawalsDeath
Responsible for 25%
of withdrawals
•‫ضضضضضض‬ ‫ضض‬ ‫ضضضضضضض‬ ‫ضضضضض‬ ‫ضضضضض‬ ‫ضضض‬
:‫ضضض‬ ‫ضضضضضضضض‬
o‫ضض‬ ‫ضضضضضضض‬ ‫ضضضضضضض‬ ‫ضضضضضضضض‬
‫ضضضضضضضض‬ ‫ضضض‬ ‫ضض‬ ‫ضضضضضضض‬ ‫ضضضضضض‬
‫ض‬ ‫ضضضضضضض‬ ‫ضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضضضضض‬
‫ضضضضضضض‬
o‫ضضضضضضض‬ ‫ضض‬ ‫ضضضضضضضضض‬ ‫ضضضضضضضض‬
‫ضضضضضضضض‬ ‫ضضض‬Observational
Studies
o‫ضضضضضضضض‬ ‫ضضضضضضض‬
o‫ضضضضضضضض‬ ‫ضضضضضضضضض‬Systemic
Reviews
o‫ضضضضضضضضض‬ ‫ضضضضضضضض‬ ‫ضض‬animal
•‫ض‬ ‫ضضض‬ ‫ضضضض‬ ‫ضضض‬ ‫ضضضضضض‬ ‫ضضضضض‬ ‫ضضضضض‬ ‫ضضض‬ ‫ضض‬ ‫ضضض‬
:‫ضضض‬ ‫ضضضضضضض‬ ‫ضضضض‬ ‫ضضضض‬ ‫ضضض‬
o‫ضضضضضض‬ ‫ضضض‬ ‫ضضضضضض‬ ‫ضض‬ ‫ضضضضضض‬ ‫ضض‬ ‫ضضضضض‬ ‫ضضض‬
o‫ضضضضضض‬ ‫ضضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضض‬ ‫ضضضض‬ ‫ضضض‬ ‫ضضضض‬
‫ضضضضض‬ ‫ضضضضضضض‬ ‫ضضضضضضض‬ ‫ضضض‬ ‫ضضضضض‬ ‫ضضضضضض‬
o‫ضضضضضضض‬ ‫ض‬ ‫ضضضضضضضض‬ ‫ضضضضضضضض‬ ‫ضضض‬
•‫ضضضضض‬ ‫ضض‬ ‫ضضضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضضضضض‬ ‫ض‬ ‫ضضضضض‬ ‫ضضضض‬
‫ضض‬ ‫ضضض‬ ‫ضضضضضضض‬ ‫ضضضض‬ ‫ضضض‬ ‫ضضضضضض‬ ‫ضضضضض‬ ‫ضضضضض‬ ‫ضض‬
‫ضضضضض‬95‫ضضضضضض‬ ‫ضضضضضض‬ ‫ضضضضضض‬ ‫ضضضض‬
•‫ضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضضض‬ ‫ضضضض‬ ‫ضضضض‬ ‫ضض‬ ‫ضضض‬ ‫ضضضضض‬ ‫ضضض‬
‫ضضضضضضض‬ ‫ض‬ ‫ضضضضضض‬ ‫ضضض‬ ‫ضضضضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضضضضض‬
•‫ضضضض‬ ‫ضضضض‬ ‫ضضضضضضضض‬ ‫ضضضضضضضضض‬ ‫ض‬ ‫ضضضضضضضض‬
‫ض‬ ‫ضضضضض‬ ‫ضضضضضض‬ ‫ضض‬ ‫ضضضضضض‬ ‫ضضضضضض‬ ‫ضضضضضض‬
‫ضضضضضضض‬ ‫ضضضضضضضض‬
•‫ءءءءءء‬ ‫ءءء‬ ‫ءءءءء‬ ‫ءءء‬ ‫ءء‬ ‫ءءءءءءء‬ ‫ءءءءءء‬
‫ءءءءءء‬ ‫ءء‬ ‫ءءءءء‬ ‫ءءءء‬ ‫ءءءء‬ ‫ءءءء‬ ‫ء‬ ‫ءءءءء‬ ‫ءء‬
‫ءءءءءءء‬ ‫ءءءءءءء‬
•‫ءءء‬ ‫ءء‬ ‫ءءءءء‬ ‫ءءءءءء‬ ‫ءءءءء‬ ‫ءءء‬ ‫ءءءء‬ ‫ءءءء‬
‫ءءء‬ ‫ءءءءءء‬ ‫ءء‬ ‫ءءءءءء‬
•‫ءءءءءءء‬ ‫ءءءءء‬ ‫ءءءءء‬ ‫ءء‬ ‫ءءءءءء‬ ‫ءءءءء‬
‫ءءءءءء‬ ‫ءءءءء‬ ‫ءءءءء‬ ‫ءءءء‬ ‫ءءء‬ ‫ءءءءءءء‬
‫ءءءءءءءء‬ ‫ءءءءءءء‬
•‫ءء‬ ‫ءءءءءء‬ ‫ءءءءء‬ ‫ءءءء‬ ‫ءء‬ ‫ءءءءءءء‬ ‫ءءءءء‬
‫ءءء‬ ‫ءءءءء‬60‫ءءءء‬
•‫ءءءءءء‬ ‫ءء‬ ‫ءءءء‬ ‫ءءءء‬ ‫ءءءءءء‬ ‫ءءءءءءء‬
‫ءءءءءءءءء‬
Drug name Withdrawn Country Remarks
Adderall XR 2005 Canada Risk of stroke. The ban
was later lifted because
the death rate among
those taking Adderall XR
was determined to be no
greater than those not
taking Adderall.
Alatrofloxacin 2006 Worldwide Liver toxicity; serious
liver injury leading to
liver transplant; death
Alclofenac 1979 UK Vasculitis, Rash
Astemizole (Hismanal) 1999 US, Malaysia, Multiple
Nonspecified Markets
Fatal arrhythmia
Some examples of withdrawn drugsSome examples of withdrawn drugs
This is the end
This is the end

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How To Withdraw Drugs From The Market

  • 1. ‫ققققق‬ ‫قق‬ ‫ققققققق‬ ‫قققق‬ ‫ققق‬ How To Withdraw Drug(s) From The Market By Dr. Mohammad AlmermeshBy Dr. Mohammad Almermesh Sunday, April 03, 2016Sunday, April 03, 2016
  • 2. ‫قققق‬ ‫قققق‬ •‫قققققق‬ ‫ققققق‬ ‫ققققق‬ ‫ققققق‬ ‫قق‬ ‫قققق‬ ‫قققققق‬ ‫ققققققق‬ ‫قققققق‬ ‫ققق‬ ‫قققق‬ ‫قق‬ ‫ققققق‬ •‫قق‬ ‫قققق‬ ‫قق‬ ‫ققققققققق‬ ‫قق‬ ‫قققققق‬ ‫قققققق‬ ‫ققققق‬ ‫قققققققق‬ ‫ققققققق‬ •‫ققققق‬ ‫ققق‬ ‫قققق‬ ‫قققققق‬ ‫ققققق‬ ‫ققق‬ ‫ققق‬ ‫قققق‬ •‫ق‬ ‫قققققققق‬ ‫قق‬ ‫ققققق‬ ‫قققققق‬ ‫ققققققق‬ ‫ققق‬ ‫قققق‬ ‫قققق‬ ‫قققققق‬ ‫ققق‬ ‫ققققققق‬ ‫ققق‬ ‫قققققق‬ ‫قق‬ ‫قققققق‬ ‫ق‬ ‫ققققق‬ •‫ق‬ ‫ققققق‬ ‫ققققققق‬ ‫ققققق‬ ‫قق‬ ‫قققققققق‬ ‫قققققق‬ ‫ققق‬ ‫ققققق‬ ‫ققق‬ ‫ققققققق‬ ‫قققققققق‬‫قق‬ ‫ققققققق‬ ‫قققققق‬ ‫قققق‬ ‫)ققق‬ (‫ققققق‬ ‫قق‬ ‫ققققققق‬ ‫ققق‬ ‫ققققق‬ ‫ققق‬ •‫ققق‬ ‫قق‬ ‫قق‬ ‫ققققققق‬ ‫ققققققق‬ ‫قققققققق‬ ‫قققق‬ ‫قققققق‬ ‫قققققققق‬ ‫قق‬ ‫قققققققق‬ ‫ققق‬ ‫قق‬ ‫ققققق‬ ‫ققققق‬ ‫قق‬ ‫ققققق‬ ‫ققق‬ ‫قققققققق‬FDA‫ققق‬ ‫قققققق‬ ‫قق‬EMA‫ققققققق‬ ‫قق‬
  • 3. ))A systemic reviewA systemic review 462 Drugswithdrawn from market (1953- 2013) Most common reason is Hepatotoxicity Immune-mediated Reactions 72% anecdotal (verbal) reports 9.34 % withdrawn worldwide 39 % were withdrawn in one country only less likely in Africa Responsible for 30% of withdrawalsDeath Responsible for 25% of withdrawals
  • 4.
  • 5. •‫ضضضضضض‬ ‫ضض‬ ‫ضضضضضضض‬ ‫ضضضضض‬ ‫ضضضضض‬ ‫ضضض‬ :‫ضضض‬ ‫ضضضضضضضض‬ o‫ضض‬ ‫ضضضضضضض‬ ‫ضضضضضضض‬ ‫ضضضضضضضض‬ ‫ضضضضضضضض‬ ‫ضضض‬ ‫ضض‬ ‫ضضضضضضض‬ ‫ضضضضضض‬ ‫ض‬ ‫ضضضضضضض‬ ‫ضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضضضضض‬ ‫ضضضضضضض‬ o‫ضضضضضضض‬ ‫ضض‬ ‫ضضضضضضضضض‬ ‫ضضضضضضضض‬ ‫ضضضضضضضض‬ ‫ضضض‬Observational Studies o‫ضضضضضضضض‬ ‫ضضضضضضض‬ o‫ضضضضضضضض‬ ‫ضضضضضضضضض‬Systemic Reviews o‫ضضضضضضضضض‬ ‫ضضضضضضضض‬ ‫ضض‬animal
  • 6. •‫ض‬ ‫ضضض‬ ‫ضضضض‬ ‫ضضض‬ ‫ضضضضضض‬ ‫ضضضضض‬ ‫ضضضضض‬ ‫ضضض‬ ‫ضض‬ ‫ضضض‬ :‫ضضض‬ ‫ضضضضضضض‬ ‫ضضضض‬ ‫ضضضض‬ ‫ضضض‬ o‫ضضضضضض‬ ‫ضضض‬ ‫ضضضضضض‬ ‫ضض‬ ‫ضضضضضض‬ ‫ضض‬ ‫ضضضضض‬ ‫ضضض‬ o‫ضضضضضض‬ ‫ضضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضض‬ ‫ضضضض‬ ‫ضضض‬ ‫ضضضض‬ ‫ضضضضض‬ ‫ضضضضضضض‬ ‫ضضضضضضض‬ ‫ضضض‬ ‫ضضضضض‬ ‫ضضضضضض‬ o‫ضضضضضضض‬ ‫ض‬ ‫ضضضضضضضض‬ ‫ضضضضضضضض‬ ‫ضضض‬ •‫ضضضضض‬ ‫ضض‬ ‫ضضضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضضضضض‬ ‫ض‬ ‫ضضضضض‬ ‫ضضضض‬ ‫ضض‬ ‫ضضض‬ ‫ضضضضضضض‬ ‫ضضضض‬ ‫ضضض‬ ‫ضضضضضض‬ ‫ضضضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضضض‬95‫ضضضضضض‬ ‫ضضضضضض‬ ‫ضضضضضض‬ ‫ضضضض‬ •‫ضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضضض‬ ‫ضضضض‬ ‫ضضضض‬ ‫ضض‬ ‫ضضض‬ ‫ضضضضض‬ ‫ضضض‬ ‫ضضضضضضض‬ ‫ض‬ ‫ضضضضضض‬ ‫ضضض‬ ‫ضضضضضض‬ ‫ضضضضض‬ ‫ضض‬ ‫ضضضضضضض‬ •‫ضضضض‬ ‫ضضضض‬ ‫ضضضضضضضض‬ ‫ضضضضضضضضض‬ ‫ض‬ ‫ضضضضضضضض‬ ‫ض‬ ‫ضضضضض‬ ‫ضضضضضض‬ ‫ضض‬ ‫ضضضضضض‬ ‫ضضضضضض‬ ‫ضضضضضض‬ ‫ضضضضضضض‬ ‫ضضضضضضضض‬
  • 7. •‫ءءءءءء‬ ‫ءءء‬ ‫ءءءءء‬ ‫ءءء‬ ‫ءء‬ ‫ءءءءءءء‬ ‫ءءءءءء‬ ‫ءءءءءء‬ ‫ءء‬ ‫ءءءءء‬ ‫ءءءء‬ ‫ءءءء‬ ‫ءءءء‬ ‫ء‬ ‫ءءءءء‬ ‫ءء‬ ‫ءءءءءءء‬ ‫ءءءءءءء‬ •‫ءءء‬ ‫ءء‬ ‫ءءءءء‬ ‫ءءءءءء‬ ‫ءءءءء‬ ‫ءءء‬ ‫ءءءء‬ ‫ءءءء‬ ‫ءءء‬ ‫ءءءءءء‬ ‫ءء‬ ‫ءءءءءء‬ •‫ءءءءءءء‬ ‫ءءءءء‬ ‫ءءءءء‬ ‫ءء‬ ‫ءءءءءء‬ ‫ءءءءء‬ ‫ءءءءءء‬ ‫ءءءءء‬ ‫ءءءءء‬ ‫ءءءء‬ ‫ءءء‬ ‫ءءءءءءء‬ ‫ءءءءءءءء‬ ‫ءءءءءءء‬ •‫ءء‬ ‫ءءءءءء‬ ‫ءءءءء‬ ‫ءءءء‬ ‫ءء‬ ‫ءءءءءءء‬ ‫ءءءءء‬ ‫ءءء‬ ‫ءءءءء‬60‫ءءءء‬ •‫ءءءءءء‬ ‫ءء‬ ‫ءءءء‬ ‫ءءءء‬ ‫ءءءءءء‬ ‫ءءءءءءء‬ ‫ءءءءءءءءء‬
  • 8. Drug name Withdrawn Country Remarks Adderall XR 2005 Canada Risk of stroke. The ban was later lifted because the death rate among those taking Adderall XR was determined to be no greater than those not taking Adderall. Alatrofloxacin 2006 Worldwide Liver toxicity; serious liver injury leading to liver transplant; death Alclofenac 1979 UK Vasculitis, Rash Astemizole (Hismanal) 1999 US, Malaysia, Multiple Nonspecified Markets Fatal arrhythmia Some examples of withdrawn drugsSome examples of withdrawn drugs
  • 10. This is the end