Anaphylactic shock caused by impurities in orgotein preparations

Abstract

Previously reported allergic reactions to orgotein (superoxide dismutase) injections has assigned responsibility to this molecule, which is obtained from bovine liver. We report an anaphylactic shock probably caused by impurities contained in an orgotein preparation. Prick test to Peroxinorm (orgotein), BSA, and cow liver extract were positive but resulted negative with chymotrypsin, milk, meat and cow epithelium extracts. Tryptase levels determined 3, 24 hours and 15 days after the shock measured 6.32, 0.81 and 0.84 U/L respectively. Detection of specific IgE to Peroxinorm, BSA and chymotrypsin by ELISA was negative and positive to cow liver. Specific IgE to milk and cow epithelium by Pharmacia CAP system was negative. Immunoblotting with Peroxinorm revealed IgE specific bands at an apparent M.W of 67, 51, 56 and 16 kDa; immunoblotting with cow liver revealed bands at 72, 56, 50 and 36 kDa; immunoblotting with BSA and chymotypsin were negative. This case emphasises the role that 20 % of impurities of the pharmaceutical preparation may have in immediate hypersensitivity reactions.

Superoxide Dismutase Administration: A Review of Proposed Human Uses

“…Bovine SOD, known as orgotein, was usually preferred. However, it can be limited by its intramuscular administration, administration frequency (2~3 times weekly) [ 9 ], and possible toxicity, caused by the presence of 20% impurities (albumin and chymotrypsin are the primary contaminants), in the pharmaceutical preparation that may result in immediate hypersensitivity reactions [ 18 ], and other side effects, including allergy [ 16 ]. Orgotein, marketed for the treatment of a range of inflammatory diseases, was withdrawn from European countries [ 18 ], due to allergic reactions, and limited to veterinary use in the US.…”

Subcutaneous Administration of Bovine Superoxide Dismutase Protects Lungs from Radiation Induced Lung Injury

“…Despite its efficacy, there are several safety concerns about its use in the humans. Orgotein is an extract of SOD enzymes from bovine liver, which raise concerns about its unwanted effects in humans due to anaphylactic shocks [48][49][50]. Anaphylactic reactions to the drug ultimately led to its removal from the market in the US and most European countries [26] (Spain is rare exception where Orgotein is still in clinical trials [51][52][53]).…”

Role of oxidative stress in neurodegenerative disorders: a review of reactive oxygen species and prevention by antioxidants

“… 43 One bovine source of SOD, called orgotein, can be administered intramuscularly but can contain some contaminants that cause hypersensitivity. 44 Recent developments in pharmaceutical advancements have produced avasopasem Mn (GC4419), a SOD mimetic, that can selectively reduce superoxide anions to hydrogen peroxide molecules. The drug has been developed by Galeria.…”