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[SANET-MG] FDA warnings on monoclonal antibody drugs
The information below may be of some interest to those concerned with
the secretive open field testing of human gene products as
pharmaceuticals produced in maize, soy or other food crops. It is
important for governments to stop such current tests and to reveal the
locations of previous tests and the exact nature of the human genes
being engineered into food crops.
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).
Orthoclone OKT 3 mouse monoclonal antibody, Ortho Biotech, Transplant
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.
ReoPro humanized mouse monoclonal antibody Centocor, prevents blood
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
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.
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.
Simulect humanized mouse monoclonal antibody, Novartis transplant
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.
Synagis humanized mouse monoclonal antibody, Medimmune, anti-respiratory
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.
Remicade, humanized mouse monoclonal antibody, Centocor anti-arthritis
Warning; tuberculosis infection some fatal
Herceptin (Trastuzumab) humanized mouse monoclonal antibody, Genetech
Warning: CARDIOMYOPATHY: HERCEPTIN administration can result in the
development of ventricular dysfunction and congestive heart failure.
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
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
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.
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
Xolair humanized mouse monoclonal antibody, Genetech treatment of
Warning: more patients treated with Xolair developed a new or recurrent
cancer compared to control patients.
Bexxar (Tositumomab and Iodine I 131) mouse monoclonal antibody Corixa
company, cancer therapy
Warning: Hypersensitivity reactions, including anaphylaxis.
Raptiva humanized mouse monoclonal antibody, Genetech, treatment of
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.
Erbitux humanized mouse monoclonal antibody, Imclone systems, cancer
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
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
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.
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