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Review Antihemophilic View Antihemophilic Adverse Event Reports: patient, weighting 24.25 lb, was diagnosed with factor viii deficiency and took Antihemophilic 500 Iu, Weekly

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Showing 1-25 of 38 

Factor Viii Inhibition (8463875-5)
on Jun 20, 2012 Male patient from TURKEY , weighting 24.25 lb, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (human)(View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition. Antihemophilic Factor (human) dosage: 500 Iu, Weekly.

Nausea, Vertigo, Peripheral Vascular Disorder (8381088-2)
Patient was taking Antihemophilic Factor (human) (View Usage). Patient had the following side effects: nausea (nausea Questions), vertigo, peripheral vascular disorder on May 01, 2012 from GERMANY Additional patient health information: Female patient , 17 years of age, was diagnosed with
  • von willebrand's disease
and. Antihemophilic Factor (human) dosage: 2000 Iu Prn Intravenous (not Otherwise Specified). Patient was hospitalized.

Von Willebrand's Disease (8255192-3)
Adverse event was reported on Mar 29, 2012 by a Female patient taking Antihemophilic Factor (human) (View Usage) (Dosage: N/A) . Location: JAPAN , weighting 6.61 lb, After Antihemophilic was administered, patient had the following side effects: von willebrand's disease.

Von Willebrand's Disease (8229029-2)
on Mar 14, 2012 Female patient from JAPAN , weighting 6.61 lb, was treated with Antihemophilic Factor (human) (View Usage). Patient experienced the following unwanted or unexpected effects: von willebrand's disease. Antihemophilic Factor (human) dosage: N/A.


Caesarean Section, Maternal Exposure During Pregnancy (8214911-2)
on Mar 14, 2012 Female patient from JAPAN , 34 years of age, was treated with Antihemophilic Factor (human)(View Usage). Patient had the following side effects: caesarean section, maternal exposure during pregnancy. Antihemophilic Factor (human) dosage: Unk.

Factor Viii Inhibition (8139322-X)
Patient was taking Antihemophilic Factor Nos (View Usage). After Antihemophilic was administered, patient had the following side effects: factor viii inhibition on Feb 09, 2012 from TURKEY Additional patient health information: Male patient , weighting 20.28 lb, was diagnosed with
  • factor viii deficiency
and. Antihemophilic Factor Nos dosage: 500 Unk, Unk.

(8104591-9)
Adverse event was reported on Jan 24, 2012 by a Male patient taking Antihemophilic Factor Nos (View Usage) (Dosage: N/A) . Location: UNITED STATES , 49 years of age, .

Maternal Exposure During Pregnancy, Caesarean Section, No Adverse Event (8104002-3)
on Jan 25, 2012 Female patient from JAPAN , 31 years of age, was diagnosed with
  • factor viii deficiency
  • factor v deficiency
and was treated with Antihemophilic Factor Viii (recombinant), Sucrose Formulated (View Usage). Patient had the following side effects: maternal exposure during pregnancy, caesarean section, no adverse event. Antihemophilic Factor Viii (recombinant), Sucrose Formulated dosage: N/A.

Alanine Aminotransferase Increased, Anti Factor Viii Antibody Positive, Streptococcus Test Positive, Complement Factor C3 Decreased, Tachypnoea, Glomerulonephritis Rapidly Progressive, Lung Infiltration, Abdominal Distension (7941856-5)
on Nov 18, 2011 Male patient from UNITED STATES , child 9 years of age, was treated with Antihemophilic Factor (human)(View Usage). After Antihemophilic was administered, patient had the following side effects: alanine aminotransferase increased, anti factor viii antibody positive, streptococcus test positive, complement factor c3 decreased, tachypnoea, glomerulonephritis rapidly progressive, lung infiltration, abdominal distension. Antihemophilic Factor (human) dosage: 8 Iu/kg, Q1hr, During Hospital Admission.

Factor Viii Inhibition (7937989-X)
Patient was taking Antihemophilic Factor (human) (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition on Nov 18, 2011 from GERMANY Additional patient health information: Male patient , weighting 23.15 lb, . Antihemophilic Factor (human) dosage: 1250 Iu, 2x/day. Patient was hospitalized.

Renal Impairment (7799222-1)
Adverse event was reported on Sep 28, 2011 by a Male patient taking Antihemophilic Factor (human) (View Usage) (Dosage: Daily Dose 2000 U) was diagnosed with
  • factor viii deficiency
and. Location: JAPAN , 42 years of age, Patient had the following side effects: renal impairment.
Patient was taking other medications:

Haemorrhagic Diathesis, Therapeutic Response Decreased (7646789-X)
on Jul 27, 2011 Male patient from UNITED STATES , child 8 years of age, weighting 72.97 lb, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (recombinant), Sucrose Formulated Fs (View Usage). After Antihemophilic was administered, patient had the following side effects: haemorrhagic diathesis, therapeutic response decreased. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: 40 Iu/kg, Qod.

Haemorrhage, Therapeutic Response Decreased (7646788-8)
on Jul 27, 2011 Male patient from UNITED STATES , child 6 years of age, weighting 51.81 lb, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (recombinant), Sucrose Formulated Fs(View Usage). Patient experienced the following unwanted or unexpected effects: haemorrhage, therapeutic response decreased. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: 50 Iu/kg, Qod.

Anti Factor Viii Antibody Positive, Haematoma (7646787-6)
Patient was taking Antihemophilic Factor (recombinant), Sucrose Formulated Fs (View Usage). Patient had the following side effects: anti factor viii antibody positive, haematoma on Jul 27, 2011 from MEXICO Additional patient health information: Male patient , child 10 years of age, weighting 70.55 lb, was diagnosed with
  • factor viii deficiency
and. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: N/A.

Factor Viii Inhibition (7629349-6)
Adverse event was reported on Jul 13, 2011 by a Male patient taking Antihemophilic Factor (human) (View Usage) (Dosage: 3549.0iu Given For Initial Recovery) was diagnosed with
  • factor viii deficiency
and. Location: CHINA , 32 years of age, weighting 169.8 lb, After Antihemophilic was administered, patient had the following side effects: factor viii inhibition.

Factor Viii Inhibition (7629348-4)
on Jul 15, 2011 Male patient from CHINA , 29 years of age, weighting 143.3 lb, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (human) (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition. Antihemophilic Factor (human) dosage: 3000iu Given For Initial Recovery.

Factor Viii Inhibition (7629344-7)
on Jul 15, 2011 Male patient from CHINA , 20 years of age, weighting 88.18 lb, was treated with Antihemophilic Factor (human)(View Usage). Patient had the following side effects: factor viii inhibition. Antihemophilic Factor (human) dosage: 1000.0iu Given On Demand.

No Adverse Event (7607560-8)
Patient was taking Antihemophilic Factor Nos (View Usage). After Antihemophilic was administered, patient had the following side effects: no adverse event on Jun 29, 2011 from UNITED STATES Additional patient health information: Male patient , 29 years of age, weighting 155.2 lb, . Antihemophilic Factor Nos dosage: 1775 U, Tiw.

Hepatitis C, Hepatic Cirrhosis, Hepatic Neoplasm Malignant (7596336-6)
Adverse event was reported on Jun 29, 2011 by a Male patient taking Antihemophilic Factor (human) (View Usage) (Dosage: N/A) was diagnosed with
  • factor viii deficiency
and. Location: UNITED STATES , weighting 83.78 lb, Patient experienced the following unwanted or unexpected effects: hepatitis c (hepatitis c Questions), hepatic cirrhosis, hepatic neoplasm malignant.
Patient was taking other medications:

Headache, Nausea, Hypersensitivity (7383678-2)
on Mar 21, 2011 Male patient from UNITED STATES , 50 years of age, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (recombinant), Sucrose Formulated Fs (View Usage). Patient had the following side effects: headache (headache Questions), nausea (nausea Questions), hypersensitivity. Antihemophilic Factor (recombinant), Sucrose Formulated Fs dosage: N/A.

Depression, Nervousness, Multi-organ Failure, Renal Disorder, Emotional Distress, Anxiety, Renal Injury, Fear (7382410-6)
on Mar 09, 2011 Male patient from UNITED STATES , weighting 282.2 lb, was treated with Antihemophilic Factor (human)(View Usage). After Antihemophilic was administered, patient had the following side effects: depression (depression Questions), nervousness, multi-organ failure, renal disorder, emotional distress, anxiety (anxiety Questions), renal injury, fear. Antihemophilic Factor (human) dosage: 12,000 Units.
Patient was taking other medications:

Factor Viii Inhibition, Haemorrhage (7236886-5)
Patient was taking Antihemophilic Factor (human) (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition, haemorrhage on Jan 12, 2011 from NETHERLANDS Additional patient health information: Female patient , 18 years of age, was diagnosed with
  • factor viii deficiency
and. Antihemophilic Factor (human) dosage: N/A.

Haemorrhage, Factor Viii Inhibition (7236884-1)
Adverse event was reported on Jan 12, 2011 by a Female patient taking Antihemophilic Factor (human) (View Usage) (Dosage: N/A) was diagnosed with
  • factor viii deficiency
and. Location: NETHERLANDS , 18 years of age, Patient had the following side effects: haemorrhage, factor viii inhibition.

Factor Viii Inhibition, Haemorrhage (7236716-1)
on Jan 12, 2011 Female patient from NETHERLANDS , 63 years of age, was diagnosed with
  • factor viii deficiency
and was treated with Antihemophilic Factor (human) (View Usage). After Antihemophilic was administered, patient had the following side effects: factor viii inhibition, haemorrhage. Antihemophilic Factor (human) dosage: N/A.

Rash (7147807-8)
on Dec 07, 2010 Male patient from UNITED STATES , 54 years of age, weighting 173.5 lb, was diagnosed with
  • von willebrand's disease
and was treated with Antihemophilic Factor (human)(View Usage). Patient experienced the following unwanted or unexpected effects: rash (rash Questions). Antihemophilic Factor (human) dosage: 2000 Units Once Iv.

Showing 1-25 of 38 


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Side Effects reported to FDA: 38. View FDA Adverse Reports

Antihemophilic safety alerts: 2000

Reported deaths: 4

Reported hospitalizations: 4

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Helixate (antihemophilic factor [recombinant])

Voluntary withdrawal of Helixate lot number 670H071E. This lot of Helixate was tested for Factor VIII potency using a reagent known as FVIII-deficient plasma. During a routine quality assurance investigation of the testing procedure, Bayer learned that Lot 670H071 may not retain its labeled potency if held at room temperature (25° C) for 3 months. The product will remain stable if stored at 2-8° C. Further investigation has confirmed that the cause is not related to a stability issue with the product but is attributed to the reagent used during the initial testing. As of this date there have been no adverse events reported in association with this lot of Helixate.

[August 1, 2000 - Letter - Aventis Behring]

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Antihemophilic Adverse Reactions
Factor Viii Inhibition ( 17 Reports)
Haemorrhage ( 5 Reports)
Death ( 4 Reports)
Anti Factor Viii Antibody Positive ( 2 Reports)
Caesarean Section ( 2 Reports)
Maternal Exposure During Pregnancy ( 2 Reports)
Nausea ( 2 Reports) Nausea Questions
No Adverse Event ( 2 Reports)
Platelet Count Decreased ( 2 Reports)
Pulmonary Oedema ( 2 Reports)
Shock ( 2 Reports)
Therapeutic Response Decreased ( 2 Reports)
Von Willebrand's Disease ( 2 Reports)
White Blood Cell Count Decreased ( 2 Reports)
Abdominal Distension ( 1 Reports)
Alanine Aminotransferase Increased ( 1 Reports)
Anaphylactic Reaction ( 1 Reports)
Anxiety ( 1 Reports) Anxiety Questions
Complement Factor C3 Decreased ( 1 Reports)
Depression ( 1 Reports) Depression Questions
Emotional Distress ( 1 Reports)
Fear ( 1 Reports)
Glomerulonephritis Rapidly Progressive ( 1 Reports)
Haematoma ( 1 Reports)
Haemorrhagic Diathesis ( 1 Reports)
Headache ( 1 Reports) Headache Questions
Hepatic Cirrhosis ( 1 Reports)
Hepatic Neoplasm Malignant ( 1 Reports)
Hepatitis C ( 1 Reports) Hepatitis c Questions
Hypersensitivity ( 1 Reports)

side effects
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