Warnings on FDA Approved Monoclonal Antibody Drugs

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Warnings on FDA Approved Monoclonal Antibody Drugs

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Wed, 12 Apr 2006 15:32:24 +0100

 

 

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ISIS Press Release 10/04/06

 

Warnings on FDA Approved Monoclonal Antibody Drugs

******************************************

 

Prof. Joe Cummins

 

This is a compilation of safety information on monoclonal

antibody drugs already approved by the US FDA (Food and Drug

Administration), most of them posted on the FDA website. The

URLs are included at the time of compilation (23 March

2006).

 

1. Orthoclone OKT 3 mouse monoclonal antibody, Ortho

Biotech, Transplant anti-rejection

 

Safety information: Anaphylactic or anaphylactoid reactions

may occur following administration of any dose or course of

ORTHOCLONE OKT3. In addition, serious, occasionally life-

threatening or lethal, systemic, cardiovascular, and central

nervous system reactions have been reported following

administration of ORTHOCLONE OKT3. These have included:

pulmonary edema, especially in patients with volume

overload; shock, cardiovascular collapse, cardiac or

respiratory arrest, seizures, coma, cerebral edema, cerebral

herniation, blindness and paralysis.

http://www.orthobiotech.com/orthoclone.html

 

2. ReoPro humanized mouse monoclonal antibody Centocor,

prevents blood clotting

 

Side effects: Acid or sour stomach; belching; burning,

crawling, itching, numbness, prickling, " pins and needles " ,

or tingling feelings; changes in vision; delusions;

dementia; fear; heartburn; indigestion or stomach

discomfort, upset or pain; mood or mental changes; nausea;

nervousness; vomiting. http://www.drugs.com/cons/ReoPro.html

 

3. Rituxan (Rituximab) humanized mouse monoclonal antibody

Genetech, treatment of Non-Hodgkins lymphoma

 

Warning: Fatal Infusion Reactions: Deaths within 24 hours of

RITUXAN infusion have been reported. These fatal reactions

followed an infusion reaction complex which included

hypoxia, pulmonary infiltrates, acute respiratory distress

syndrome, myocardial infarction, ventricular fibrilation

orcardiogenic shock. Approximately 80% of fatal infusion

reactions occurred in association with the first infusion.

http://www.fda.gov/medwatch/SAFETY/2005/Jan_PI/Rituxan_PI.pd

f

 

4. Zenapax (daclizumab) humanized mouse monoclonal antibody,

Hoffman-La Roche, transplant immune suppression

 

Warning: Severe, acute (onset within 24 hours)

hypersensitivity reactions including anaphylaxis have been

observed both on initial exposure to ZENAPAX and following

re-exposure. These reactions may include hypotension,

bronchospasms, wheezing, laryngeal edema, pulmonary edema,

cyanosis, hypoxia, respiratory arrest, cardiac arrhythmia,

cardiac arrest, peripheral edema, loss of consciousness,

fever, rash, urticaria, diaphoresis, pruritus, and/or

injection site reactions.

http://www.fda.gov/medwatch/SAFETY/2003/zenapax.htm

 

5. Simulect humanized mouse monoclonal antibody, Novartis

transplant ant-rejection

 

Warning: severe acute (onset within 24 hours)

hypersensitivity reactions including anaphylaxis have been

observed both on initial exposure to Simulect® and/or

following re-exposure after several months. These reactions

may include hypotension, tachycardia, cardiac failure,

dyspnea, wheezing, bronchospasm, pulmonary edema,

respiratory failure, urticaria, rash, pruritus, and/or

sneezing. If a severe hypersensitivity reaction occurs,

therapy with Simulect® should be permanently discontinued.

Medications for the treatment of severe hypersensitivity

reactions including anaphylaxis should be available for

immediate use. Patients previously administered Simulect®

should only be re-exposed to a subsequent course of therapy

with extreme caution.

http://www.fda.gov/medwatch/safety/2000/simule.htm

 

6. Synagis humanized mouse monoclonal antibody, Medimmune,

anti-respiratory syncytial virus

 

Warning: Very rare cases of anaphylaxis (<1 case per 100,000

patients) have been reported following re-exposure to

Synagis (palivizumab) [see Adverse Reactions, Post-Marketing

Experience]. Rare severe acute hypersensitivity reactions

have also been reported on initial exposure or re-exposure

to palivizumab.

http://www.fda.gov/medwatch/SAFETY/2002/Synagis_PI.pdf

 

7. Remicade, humanized mouse monoclonal antibody, Centocor

anti-arthritis

 

Warning; tuberculosis infection some fatal

http://www.fda.gov/medwatch/safety/2005/Sep_PI/Remicade_PI.p

df

 

8. Herceptin (Trastuzumab) humanized mouse monoclonal

antibody, Genetech cancer therapy

 

Warning: CARDIOMYOPATHY: HERCEPTIN administration can result

in the development of ventricular dysfunction and congestive

heart failure.

http://www.accessdata.fda.gov/scripts/cder/onctools/labels.c

fm?GN=Trastuzumab

 

9. Mylotarg humanized mouse monoclonal antibody,Wyeth,

cancer therapy

 

Warning: Mylotarg administration can result in severe

hypersensitivity reactions (including anaphylaxis), and

other infusion-related reactions which may include severe

pulmonary events. Infrequently, hypersensitivity reactions

and pulmonary events have been fatal

http://www.fda.gov/medwatch/SAFETY/2004/apr_PI/Mylotarg_PI.p

df

 

10. Campath-1H (Alemtuzumab) humanized mouse monoclonal

antibody, Genzym leukemia cancer treatment

 

Warning: Campath may lower the ability of the bone marrow to

make blood cells. Some of these effects can be severe and

lead to death. Three patients in a clinical study of the

drug Campath for the treatment of Multiple Sclerosis (MS)

developed severe idiopathic thrombocytopenic purpura (ITP).

http://www.fda.gov/cder/drug/InfoSheets/patient/alemtuzumabP

IS.pdf

 

11. Zevalin Mouse monoclonal antibody, Biogen Idec cancer

therapy (Yttrium radio therapy associated)

 

Warning: Deaths have occurred within 24 hours of Rituximab

infusion, an essential component of the ZEVALIN therapeutic

regimen. These fatalities were associated with an infusion

reaction symptom complex that included hypoxia, pulmonary

infiltrates, acute respiratory distress syndrome, myocardial

infarction, ventricular fibrillation, or cardiogenic shock.

http://www.accessdata.fda.gov/scripts/cder/onctools/labels.c

fm?GN=Ibritumomab%20Tiuxetan

 

12. Humira Human monoclonal antibody, Abott arthritis

treatment

 

Warning: TUBERCULOSIS (FREQUENTLY DISSEMINATED OR

EXTRAPULMONARY AT CLINICAL PRESENTATION), INVASIVE FUNGAL

INFECTIONS, AND OTHER OPPORTUNISTIC INFECTIONS, HAVE BEEN

OBSERVED IN PATIENTS RECEIVING HUMIRA. SOME OF THESE

INFECTIONS HAVE BEEN FATAL

http://www.fda.gov/medwatch/safety/2005/Oct_PI/Humira_PI.pdf

 

13. Xolair humanized mouse monoclonal antibody, Genetech

treatment of allergic asthma

 

Warning: more patients treated with Xolair developed a new

or recurrent cancer compared to control patients.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printe

r.cfm?id=153

 

14. Bexxar (Tositumomab and Iodine I 131) mouse monoclonal

antibody Corixa company, cancer therapy

 

Warning: Hypersensitivity reactions, including anaphylaxis.

http://www.fda.gov/cder/foi/label/2003/tosicor062703LB.pdf

 

15. Raptiva humanized mouse monoclonal antibody, Genetech,

treatment of psoriasis

 

Warning: Hemolytic anemia; serious infections has been

updated to include rare postmarketing reports of necrotizing

fasciitis, tuberculous pneumonia, bacterial sepsis with

seeding of distant sites, severe pneumonia with neutropenia,

and worsening of infection (e.g. cellulitis,pneumonia)

despite antimicrobial treatment.

http://www.fda.gov/medwatch/safety/2005/raptiva_deardoc_0712

05.pdf

 

16. Erbitux humanized mouse monoclonal antibody, Imclone

systems, cancer therapy

 

Warning: Severe infusion reactions occurred with the

administration of ERBITUX in approximately 3% of patients,

rarely with fatal outcome (<1 in 1000). Severe infusion

reactions are characterized by rapid onset of airway

obstruction (bronchospasm, stridor, hoarseness), urticaria,

and hypotension.

http://www.fda.gov/medwatch/safety/2005/Sep_PI/Erbitux_PI.pd

f

 

17. Avastin humanized mouse monoclonal antibody Genetech,

cancer therapy

 

Warning: AVASTIN administration can result in the

development of gastrointestinal perforation and wound

dehiscence, in some instances resulting in fatality.

Gastrointestinal perforation, sometimes associated with

intra-abdominal abscess, occurred throughout treatment with

AVASTIN. Serious, and in some cases fatal, hemoptysis has

occurred in patients with non–small cell lung cancer treated

with chemotherapy and AVASTIN.

http://www.fda.gov/cder/foi/label/2004/125085lbl.pdf

 

18. Tsabri humanized mouse monoclonal antibody, Biogen Idec,

treatment of multiple sclerosis (MS)

 

Suspended Marketing of Tysabri (natalizumab) 2005: FDA is

issuing this public health advisory to inform patients and

health care providers about the suspended marketing of

Tysabri (natalizumab) due to two serious adverse events

reported with its use. FDA has received a report from Biogen

Idec, the manufacturer of Tysabri, of one confirmed, fatal

case and one additional case of progressive multifocal

leukoencephalopathy (PML) in patients receiving Tysabri for

multiple sclerosis (MS). Both patients were enrolled in a

long-term clinical trial and had been taking Tysabri for

more than two years.

http://www.fda.gov/cder/drug/advisory/natalizumab.htm

 

 

 

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