Science in Society Archive

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.

  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. Remicade,  humanized mouse monoclonal antibody, Centocor anti-arthritis

Warning; tuberculosis infection some fatal

  1. 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.

  1. 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

  1. 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).

  1. 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.

  1. Humira Human monoclonal antibody, Abott  arthritis treatment


  1. 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.

  1. Bexxar (Tositumomab and Iodine I 131) mouse monoclonal antibody Corixa company, cancer therapy 

Warning: Hypersensitivity reactions, including anaphylaxis.

  1. 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.

  1. 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.

  1. 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.

  1. 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.

Article first published 10/04/06

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Liz Chafer Comment left 6th October 2009 06:06:16
All the wind turbines installed in Germany have had little impact on Co2 emissions in that country due to the intermittency of wind . The same is the case for Denmark cf. the CEPOS report sept 2009 In many countries including USA Canada France and the UK there is immense pressure to install industrial wind turbines often within a mile of houses affecting the health of those living in the vicinity. Even where I live the load factor will only be 15% but lack of wind doesn't seem to present a problem to the wind industry promoters. Intermittency is a serious problem until there is a means of stocking the energy produced.There are other forms of renewable energy that should be developed in preference to that of wind - wave power for example.

Mark Russell Comment left 24th October 2009 02:02:38
Those are big, sweeping statements about nuclear ... "the nuclear black hole in terms of cost, safety and sustainability." All (except maybe sustainability in the grand scheme) are nothing more than populist fears, and not based on fact or reality. Wind power is positively medival by comparison no matter how you dress it up. Once the planet is out of all other forms of energy wind power may make sense (and by implication it is last on my list of desirable technologies). By that time the place will look like "planet of the apes" anyway so wind power will fit right in.

Mae-Wan Ho Comment left 23rd October 2009 06:06:49
All you people against wind and pro-nuclear really want to come down to earth and look at the nuclear black hole in terms of cost, safety and unsustainability. We are not for big wind farms. Cheap affordable small wind turbines are here! Read our complete report and get a full picture. Join the dots and join the future.

Mark Russell Comment left 23rd October 2009 06:06:18
Once the "storage solution" is worked out, why would you fill that storage with energy produced by industrial wind turbines when you could fill it with energy produced by nuclear power at a fraction of the cost, and without the massive eyesore that are wind farms? A storage solution notwithstanding, the cost of wind power in general will cause countries that have committed to wind power losing almost all of their manufacturing base to countries that can supply cheap, reliable energy, whether clean or dirty (manufacturers don't really care).