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Purinethol (Mercaptopurine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Purinethol (Mercaptopurine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (29)
Death (3)
Life Threatening Events (4)

Reports by Reaction Type

Diarrhoea (8)Crohn's Disease (7)Drug Ineffective (6)Abdominal Pain (5)Rectal Haemorrhage (5)Post Procedural Infection (5)Hyperbilirubinaemia (4)Hepatosplenic T-Cell Lymphoma (4)Weight Decreased (3)Cholestasis (3)Hepatic Failure (2)Change of Bowel Habit (2)

Possible Purinethol side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male, weighing 69.0 kg (151.8 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Colitis Ulcerative
    Start date: 2007-06-15

Purinethol
    Dosage: also reported with start date of 01-oct-1999
    Start date: 1999-06-02

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Inflammatory Bowel Disease
    Start date: 2002-07-10
    End date: 2006-03-07

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Colitis Ulcerative
    Start date: 2002-07-10
    End date: 2006-03-07

Humira
    Start date: 2007-06-15

Purinethol
    Dosage: also reported with start date of 01-oct-1999
    Start date: 1999-06-02

Humira
    Start date: 2006-11-01

Purinethol
    Indication: Inflammatory Bowel Disease
    End date: 2007-04-01

Purinethol
    Indication: Colitis Ulcerative
    End date: 2007-04-01

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Crohn's Disease
    Start date: 2002-07-10
    End date: 2006-03-07

Humira
    Indication: Irritable Bowel Syndrome
    Start date: 2006-11-01

Other drugs received by patient: Prednisone TAB; Asacol; Prednisone TAB; Asacol



Possible Purinethol side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-25

Patient: 49 year old female

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Purinethol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-15
    End date: 2011-12-30

Vesanoid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-16
    End date: 2011-12-30

Methotrexate
    Start date: 2012-01-28

Purinethol
    Start date: 2012-01-28

Methotrexate
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-15
    End date: 2011-12-30

Vesanoid
    Start date: 2012-02-07



Possible Purinethol side effects in 26 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-06-25

Patient: 26 year old female

Reactions: Pustular Psoriasis, Sacroiliitis

Drug(s) suspected as cause:
Humira
    Dosage: week 0 and 2
    Start date: 2012-02-21

Purinethol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-21

Remicade
    Dosage: as necessary; 100 mg
    Indication: Colitis Ulcerative
    Start date: 2011-10-14
    End date: 2012-01-12

Humira
    Indication: Colitis Ulcerative
    End date: 2012-03-06

Other drugs received by patient: Calcium Carbonate / Cholecalciferol



Possible Purinethol side effects in male

Reported by a lawyer from United States on 2012-06-22

Patient: male, weighing 81.6 kg (179.5 pounds)

Reactions: Adenocarcinoma, Osteoporosis, Colitis Ulcerative, Crohn's Disease, Anaemia Macrocytic, Inflammatory Bowel Disease

Drug(s) suspected as cause:
Prednisone TAB
    Indication: Crohn's Disease

Accutane
    Administration route: Oral
    Indication: Acne
    Start date: 1984-01-12
    End date: 1984-06-03

Purinethol
    Indication: Crohn's Disease

Other drugs received by patient: Boniva



Possible Purinethol side effects in female

Reported by a physician from France on 2012-06-13

Patient: female

Reactions: Failed Induction of Labour, Proteinuria, Urinary Tract Infection, Oedema, PRE-Eclampsia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Colitis Ulcerative

Purinethol
    Administration route: Oral
    Indication: Colitis Ulcerative
    End date: 2012-04-03

Other drugs received by patient: Prednisone TAB



Possible Purinethol side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-24

Patient: female

Reactions: Weight Decreased, Jaundice, Hyperbilirubinaemia, Diarrhoea, Transaminases Increased, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate
    Dosage: 25 mg once weekly
    Indication: Acute Lymphocytic Leukaemia
    End date: 2009-10-28

Micardis
    Administration route: Oral
    Start date: 2009-08-15
    End date: 2009-10-28

Purinethol
    Dosage: 100 mg
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-05-12
    End date: 2009-10-28

Other drugs received by patient: Zithromax



Possible Purinethol side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-19

Patient: male, weighing 68.0 kg (149.7 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma

Drug(s) suspected as cause:
Purinethol

Other drugs received by patient: Asacol



Possible Purinethol side effects in female

Reported by a physician from Israel on 2012-04-06

Patient: female, weighing 64.7 kg (142.3 pounds)

Reactions: Fistula, Anal Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Purinethol
    Dosage: mercaptopurine 40mg or 80mg or purinethol
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-11-27
    End date: 2012-02-12

Mercaptopurine
    Dosage: mercaptopurine 40mg or 80mg or purinethol
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-06-09
    End date: 2012-02-12

Other drugs received by patient: Budesonide; Pentasa



Possible Purinethol side effects in female

Reported by a physician from France on 2012-03-27

Patient: female

Reactions: Hepatic Failure, Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vesanoid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-27
    End date: 2012-01-25

Purinethol
    Dosage: 50 mg
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-21
    End date: 2012-01-25

Valacyclovir Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-21
    End date: 2012-01-25

Bactrim
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-21
    End date: 2012-01-25

Methotrexate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-21
    End date: 2012-01-25

Baraclude
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-15
    End date: 2012-01-25



Possible Purinethol side effects in female

Reported by a physician from France on 2012-03-23

Patient: female

Reactions: Hepatic Failure, Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vesanoid
    Dosage: 900mg every 3 months
    Administration route: Oral
    Indication: Chemotherapy
    Start date: 2011-10-27
    End date: 2012-01-25

Baraclude
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2011-09-15
    End date: 2012-01-25

Bactrim
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-12-21
    End date: 2012-01-25

Valacyclovir Hydrochloride
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-12-21
    End date: 2012-01-25

Purinethol
    Dosage: 1tab twice per day
    Administration route: Oral
    Indication: Chemotherapy
    Start date: 2011-12-21
    End date: 2012-01-25

Methotrexate
    Dosage: 20mg weekly
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2011-12-21
    End date: 2012-01-25

Other drugs received by patient: Viread



Possible Purinethol side effects in 7 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-08

Patient: 7 year old female

Reactions: Lung Disorder, Neutropenia, Thrombocytopenia, Leukopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Purinethol
    Dosage: 50 mg/m2/day
    Indication: T-Cell Lymphoma Stage III

Cytarabine
    Dosage: 75 mg/m2/day, for 4 days
    Indication: T-Cell Lymphoma Stage III

Other drugs received by patient: Cyclophosphamide



Possible Purinethol side effects in male

Reported by a physician from United States on 2012-02-27

Patient: male, weighing 84.0 kg (184.8 pounds)

Reactions: Abdominal Pain, Drug Ineffective, Diarrhoea, Rectal Haemorrhage, Crohn's Disease, Post Procedural Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2008-01-01

Purinethol
    Indication: Crohn's Disease
    End date: 2010-11-01

Humira
    Start date: 2011-12-01



Possible Purinethol side effects in female

Reported by a physician from Israel on 2012-02-19

Patient: female, weighing 64.7 kg (142.3 pounds)

Reactions: Fistula, Anal Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Purinethol
    Dosage: mercaptopurine 40mg or 80mg or purinethol
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-11-27
    End date: 2012-02-12

Mercaptopurine
    Dosage: mercaptopurine 40mg or 80mg or purinethol
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-06-09
    End date: 2011-09-01

Other drugs received by patient: Budesonide; Pentasa



Possible Purinethol side effects in 42 year old male

Reported by a consumer/non-health professional from Germany on 2012-02-15

Patient: 42 year old male, weighing 87.0 kg (191.4 pounds)

Reactions: Hyperbilirubinaemia, Cholestasis

Drug(s) suspected as cause:
Vincristine
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-12-26

Dasatinib
    Dosage: interrupted:12jan12 to 17jan12.
    Indication: Acute Lymphocytic Leukaemia

Cyclophosphamide
    Dosage: also taken on 25jan12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-01

Purinethol
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-07
    End date: 2012-01-09

Pegaspargase
    Dosage: 1df= 4000u
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-12-26

Methotrexate
    Dosage: also on 10jan12,18jan12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-03



Possible Purinethol side effects in 42 year old male

Reported by a consumer/non-health professional from Germany on 2012-02-14

Patient: 42 year old male, weighing 87.0 kg (191.4 pounds)

Reactions: Hyperbilirubinaemia, Cholestasis

Drug(s) suspected as cause:
Vincristine
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-12-26

Cyclophosphamide
    Dosage: also taken on 25jan12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-01

Purinethol
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-07
    End date: 2012-01-09

Dasatinib
    Dosage: interrupted:12jan12 to 17jan12.
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: also on 10jan12,18jan12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-03

Pegaspargase
    Dosage: 1df= 4000u
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-12-26



Possible Purinethol side effects in female

Reported by a physician from Israel on 2012-02-02

Patient: female, weighing 53.5 kg (117.7 pounds)

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Purinethol
    Dosage: mercaptopurine 40mg or 80mg or purinethol
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-09-26
    End date: 2011-10-02

Mercaptopurine
    Dosage: mercaptopurine 40mg or 80mg or purinethol
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-09-26
    End date: 2011-10-02

Other drugs received by patient: Pentasa



Possible Purinethol side effects in male

Reported by a physician from United States on 2012-01-23

Patient: male, weighing 84.0 kg (184.8 pounds)

Reactions: Abdominal Pain, Diarrhoea, Drug Ineffective, Rectal Haemorrhage, Crohn's Disease, Post Procedural Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Start date: 2011-02-21
    End date: 2011-11-15

Humira
    Indication: Crohn's Disease
    Start date: 2009-01-01
    End date: 2010-11-01

Purinethol
    Indication: Crohn's Disease
    End date: 2010-11-01



Possible Purinethol side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-20

Patient: male, weighing 69.0 kg (151.8 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Inflammatory Bowel Disease
    Start date: 2002-07-10
    End date: 2006-03-07

Humira
    Start date: 2006-11-01

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Colitis Ulcerative
    Start date: 2002-07-10
    End date: 2006-03-07

Humira
    Start date: 2007-06-15

Purinethol
    Indication: Colitis Ulcerative
    End date: 2007-04-01

Purinethol
    Dosage: also reported with start date of 01-oct-1999
    Start date: 1999-06-02

Humira
    Indication: Irritable Bowel Syndrome
    Start date: 2006-11-01

Purinethol
    Indication: Inflammatory Bowel Disease
    End date: 2007-04-01

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Crohn's Disease
    Start date: 2002-07-10
    End date: 2006-03-07

Humira
    Indication: Colitis Ulcerative
    Start date: 2007-06-15

Purinethol
    Dosage: also reported with start date of 01-oct-1999
    Start date: 1999-06-02

Other drugs received by patient: Asacol; Prednisone; Asacol; Prednisone



Possible Purinethol side effects in 42 year old male

Reported by a consumer/non-health professional from Germany on 2012-01-20

Patient: 42 year old male, weighing 87.0 kg (191.4 pounds)

Reactions: Hyperbilirubinaemia, Cholestasis

Drug(s) suspected as cause:
Vincristine
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-12-26

Cyclophosphamide
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-01

Purinethol
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-07
    End date: 2012-01-09

Methotrexate
    Dosage: also on 10-jan-2012
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-03

Pegaspargase
    Dosage: 1df= 4000u
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-12-26

Dasatinib
    Dosage: interrupted:12jan2012.
    Indication: Acute Lymphocytic Leukaemia



Possible Purinethol side effects in 45 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-10

Patient: 45 year old male

Reactions: Listeriosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Purinethol
    Indication: Colitis Ulcerative

Remicade
    Indication: Colitis Ulcerative
    Start date: 2011-06-01

Prednisolone
    Administration route: Oral
    Indication: Colitis Ulcerative

Other drugs received by patient: Fivasa; Imuran



Possible Purinethol side effects in male

Reported by a individual with unspecified qualification from United States on 2012-01-10

Patient: male

Reactions: Abdominal Pain, Drug Ineffective, Diarrhoea, Crohn's Disease, Rectal Haemorrhage, Post Procedural Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2009-01-01
    End date: 2010-11-01

Purinethol
    Indication: Crohn's Disease
    End date: 2010-11-01



Possible Purinethol side effects in male

Reported by a physician from United States on 2012-01-10

Patient: male

Reactions: Abdominal Pain, Diarrhoea, Drug Ineffective, Rectal Haemorrhage, Crohn's Disease, Post Procedural Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Purinethol
    Indication: Crohn's Disease
    End date: 2010-11-01

Humira
    Indication: Crohn's Disease
    Start date: 2009-01-01
    End date: 2010-11-01



Possible Purinethol side effects in male

Reported by a lawyer from United States on 2012-01-06

Patient: male, weighing 81.6 kg (179.5 pounds)

Reactions: Osteoporosis, Colitis Ulcerative, Adenocarcinoma, Crohn's Disease, Anaemia Macrocytic, Inflammatory Bowel Disease

Drug(s) suspected as cause:
Prednisone TAB
    Indication: Crohn's Disease

Accutane
    Administration route: Oral
    Indication: Acne
    Start date: 1984-01-12
    End date: 1984-06-03

Purinethol
    Indication: Crohn's Disease

Other drugs received by patient: Boniva



Possible Purinethol side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-28

Patient: male

Reactions: Abdominal Pain, Diarrhoea, Drug Ineffective, Rectal Haemorrhage, Crohn's Disease, Post Procedural Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2009-01-01
    End date: 2010-11-01

Purinethol
    Indication: Crohn's Disease
    End date: 2010-11-01



Possible Purinethol side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-08

Patient: male, weighing 85.3 kg (187.6 pounds)

Reactions: Weight Decreased, Chills, Impaired Work Ability, Pain, Headache, Change of Bowel Habit, Hyperhidrosis, Fatigue, Cough, Polydipsia, Renal Disorder, Vomiting, Pain in Extremity, Muscular Weakness, Rash, Tremor, Eating Disorder, Renal Impairment, Arthralgia, Diarrhoea, Insomnia, Increased Tendency To Bruise, Gait Disturbance, Feeling Abnormal, Disability

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2011-11-03

Purinethol
    Administration route: Oral
    Indication: Neoplasm Malignant
    Start date: 2011-10-20

Remicade
    Indication: Crohn's Disease
    Start date: 2011-10-20

Other drugs received by patient: Levothyroxine Sodium



Possible Purinethol side effects in female

Reported by a physician from Israel on 2011-12-02

Patient: female, weighing 53.5 kg (117.7 pounds)

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mercaptopurine
    Dosage: mercaptopurine 40mg or 80mg or purinethol
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-09-26
    End date: 2011-10-02

Purinethol
    Dosage: mercaptopurine 40mg or 80mg or purinethol
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-09-26
    End date: 2011-10-02

Other drugs received by patient: Pentasa



Possible Purinethol side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-24

Patient: male, weighing 85.3 kg (187.6 pounds)

Reactions: Weight Decreased, Chills, Impaired Work Ability, Headache, Hyperhidrosis, Change of Bowel Habit, Fatigue, Cough, Polydipsia, Vomiting, Pain in Extremity, Muscular Weakness, Rash, Tremor, Eating Disorder, Diarrhoea, Arthralgia, Increased Tendency To Bruise, Insomnia, Gait Disturbance, Feeling Abnormal

Drug(s) suspected as cause:
Purinethol
    Administration route: Oral
    Indication: Neoplasm Malignant
    Start date: 2011-10-20

Remicade
    Start date: 2011-11-03

Remicade
    Indication: Crohn's Disease
    Start date: 2011-10-20

Other drugs received by patient: Levothyroxine Sodium



Possible Purinethol side effects in 45 year old male

Reported by a physician from Canada on 2011-10-14

Patient: 45 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Small Intestine Carcinoma, Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2010-01-01
    End date: 2011-06-01

Purinethol
    Indication: Crohn's Disease
    Start date: 1995-01-01
    End date: 2011-06-01

Corticosteroids
    Indication: Product Used FOR Unknown Indication



Possible Purinethol side effects in male

Reported by a lawyer from United States on 2011-10-14

Patient: male, weighing 69.0 kg (151.8 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Irritable Bowel Syndrome
    Start date: 2006-11-01

Purinethol
    Dosage: also reported with start date of 01-oct-1999
    Start date: 1999-06-02

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Colitis Ulcerative
    Start date: 2002-07-10
    End date: 2006-03-07

Humira
    Start date: 2007-06-15

Purinethol
    Dosage: also reported with start date of 01-oct-1999
    Start date: 1999-06-02

Purinethol
    Indication: Colitis Ulcerative
    End date: 2007-04-01

Humira
    Indication: Colitis Ulcerative
    Start date: 2007-06-15

Purinethol
    Indication: Inflammatory Bowel Disease
    End date: 2007-04-01

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Inflammatory Bowel Disease
    Start date: 2002-07-10
    End date: 2006-03-07

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Crohn's Disease
    Start date: 2002-07-10
    End date: 2006-03-07

Humira
    Start date: 2006-11-01

Other drugs received by patient: Asacol; Asacol; Prednisone; Prednisone

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