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Amevive (Alefacept) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Amevive (Alefacept) 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 (47)
Death (7)
Life Threatening Events (3)

Reports by Reaction Type

Off Label Use (14)Diabetes Mellitus (8)Kidney Transplant Rejection (7)Death (4)Antibody Test Positive (4)Myocardial Infarction (3)Cardiac Failure Congestive (3)Depression (2)Infectious Peritonitis (2)Cellulitis (2)Renal Failure (2)Neutrophil Count Decreased (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Amevive (Alefacept). For a complete list or a specific selection of reports, please use the links above.

Possible Amevive side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: male

Reactions: Chronic Obstructive Pulmonary Disease, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Amevive
    Dosage: unk
    Start date: 2005-08-16
    End date: 2005-11-01

Amevive
    Dosage: unk
    Indication: Psoriasis
    Start date: 2005-03-01
    End date: 2005-05-17



Possible Amevive side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-09

Patient: male

Reactions: Fatigue, Pulmonary Sarcoidosis, Insomnia, Depression, Eye Disorder, Neuralgia, Herpes Zoster

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in 83 year old female

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

Patient: 83 year old female, weighing 73.0 kg (160.6 pounds)

Reactions: Atrial Fibrillation, Diastolic Dysfunction, Cerebrovascular Accident, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in 70 year old male

Reported by a physician from United States on 2012-03-29

Patient: 70 year old male

Reactions: CD4 Lymphocytes Decreased, Sepsis, Urinary Tract Infection, Platelet Count Decreased, External Ear Cellulitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amevive
    Dosage: intramuscular, intramuscular
    Indication: Psoriasis
    End date: 2010-10-01

Amevive
    Dosage: intramuscular, intramuscular
    Indication: Psoriasis
    Start date: 2011-01-01
    End date: 2011-01-01

Other drugs received by patient: Simvastatin; Omeprazole; Spiriva; Niaspan; Aspirin; Lexapro; Finasteride; Duoneb; Diltiazem; Lantus; Alprazolam; Atenolol; Trilipix (Fenofibrate)



Possible Amevive side effects in 66 year old male

Reported by a physician from United States on 2012-03-29

Patient: 66 year old male

Reactions: Off Label Use, Neuroendocrine Carcinoma of THE Skin

Drug(s) suspected as cause:
Amevive
    Indication: Psoriasis

Amevive
    Indication: Psoriatic Arthropathy

Amevive
    Indication: Rheumatoid Arthritis

Other drugs received by patient: Potassium Chloride; Prilosec; Sulfasalazine; Lasix; Phenazopyridine (Phenazopyridine); Prednisone TAB; Loratadine; Amlodipine; Zocor; Hydroxyzine; Miralax; Cozaar; Indomethacin; Celexa; Coreg; Tramadol HCL



Possible Amevive side effects in

Reported by a physician from United States on 2012-03-26

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in female

Reported by a physician from United States on 2012-02-13

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-25

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in

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

Patient:

Reactions: Cellulitis, Deep Vein Thrombosis

Drug(s) suspected as cause:
Amevive

Other drugs received by patient: Lisinopril; Tamsulosin HCL; Diamicron; Cephalexin; Furosemide; Actonel; Rivasa; Calcite; Nexium; Lipitor



Possible Amevive side effects in male

Reported by a consumer/non-health professional from Canada on 2012-01-16

Patient: male, weighing 91.0 kg (200.2 pounds)

Reactions: Chest Discomfort

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amevive

Other drugs received by patient: Pramipexole Dihychlloride; Lipitor; Misoprostol; Voltaren; Lorazepam



Possible Amevive side effects in male

Reported by a physician from United States on 2012-01-03

Patient: male, weighing 86.0 kg (189.2 pounds)

Reactions: Cardio-Respiratory Arrest, Pulmonary Embolism, Myocardial Infarction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in female

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

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in 59 year old male

Reported by a physician from United States on 2011-12-20

Patient: 59 year old male

Reactions: Off Label Use, Neutrophil Count Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Amevive
    Dosage: 15 mg, weekly
    Start date: 2011-09-30

Amevive
    Dosage: 7.5 mg, total dose
    Indication: Graft Versus Host Disease
    Start date: 2011-09-23
    End date: 2011-09-23

Amevive
    Dosage: 7.5 mg, total dose
    Start date: 2011-09-26
    End date: 2011-09-26

Other drugs received by patient: Calcium +vit D; Novolog; Norvasc; Tessalon; Specialty Vitamins Products; Zithromax; Mepron; Refresh Tears; Glucagon; Ativan; Prograf; Zithromax; Neurontin; Multi-Vitamin; Vitamin D; Ambien; Fosamax; Advair Diskus 100 / 50; Mycophenolate Mofetil (Cellcept); Prilosec; Roxicodone; Kenalog; Diflucan; Cleocin T; Zovirax; Lidoderm; Pravachol; Deltasone



Possible Amevive side effects in 49 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-12-08

Patient: 49 year old male, weighing 77.0 kg (169.4 pounds)

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-07

Patient: male, weighing 93.0 kg (204.6 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in

Reported by a consumer/non-health professional from Canada on 2011-12-06

Patient:

Reactions: Renal Failure, Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Amevive

Other drugs received by patient: Humira



Possible Amevive side effects in male

Reported by a consumer/non-health professional from Canada on 2011-12-06

Patient: male, weighing 91.0 kg (200.2 pounds)

Reactions: Chest Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: male, weighing 88.0 kg (193.6 pounds)

Reactions: Blood Glucose Increased

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in 59 year old male

Reported by a physician from United States on 2011-12-05

Patient: 59 year old male

Reactions: Off Label Use, Neutrophil Count Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in male

Reported by a physician from United States on 2011-11-29

Patient: male, weighing 109.0 kg (239.8 pounds)

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in

Reported by a consumer/non-health professional from Canada on 2011-11-16

Patient:

Reactions: Renal Failure, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-14

Patient: male

Reactions: Off Label Use, Antibody Test Positive

Drug(s) suspected as cause:
Amevive
    Dosage: 15 mg, weekly
    Indication: Renal Transplant
    Start date: 2010-09-13
    End date: 2011-09-19

Amevive
    Dosage: 15 mg, monthly

Amevive
    Dosage: 7.5 mg, unknown/d

Other drugs received by patient: Norvasc; Myfortic; Metoprolol; Bactrim



Possible Amevive side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-14

Patient: male

Reactions: Off Label Use, Antibody Test Positive

Drug(s) suspected as cause:
Amevive
    Dosage: 7.5 mg, unknown/d

Amevive
    Dosage: 15 mg, monthly

Amevive
    Dosage: 15 mg, weekly
    Indication: Renal Transplant
    Start date: 2010-10-07
    End date: 2011-09-27

Other drugs received by patient: Myfortic; Norvasc; Mepron



Possible Amevive side effects in 58 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-14

Patient: 58 year old male, weighing 93.0 kg (204.6 pounds)

Reactions: Limb Operation, Lower Limb Fracture, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-10

Patient: 57 year old male, weighing 85.0 kg (187.0 pounds)

Reactions: Klebsiella Infection, Ultrasound Scan Abnormal, Pneumonia, Cellulitis, Blastomycosis, Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prograf
    Dosage: 1 mg, q12 hours
    Indication: Product Used FOR Unknown Indication

Amevive
    Dosage: 15 mg, weekly
    Indication: Renal Transplant
    Start date: 2010-11-19
    End date: 2011-02-10



Possible Amevive side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-09

Patient: male, weighing 109.0 kg (239.8 pounds)

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in male

Reported by a individual with unspecified qualification from United States on 2011-11-09

Patient: male, weighing 86.0 kg (189.2 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Amevive



Possible Amevive side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-07

Patient: male, weighing 113.0 kg (248.6 pounds)

Reactions: Hyperlipidaemia, Cytomegalovirus Viraemia, Transient Ischaemic Attack, Cerebral Ischaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amevive
    Dosage: 7.5 mg, doses x 2
    Start date: 2010-10-29
    End date: 2010-10-31

Amevive
    Dosage: 15 mg, weekly
    Start date: 2010-11-01

Amevive
    Dosage: 15 mg, monthly
    Indication: Renal Transplant
    End date: 2011-02-23

Other drugs received by patient: Labetalol HCL; Myfortic; Multi-Vitamin; Prograf; Amlodipine



Possible Amevive side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-03

Patient: female, weighing 56.0 kg (123.2 pounds)

Reactions: Infectious Peritonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amevive

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