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General information
Adverse reactions to human serum albumin are uncommon and usually mild, such as itching and urticaria. Serious reactions are rare. A patient who has reacted violently to albumin on one occasion may tolerate it well on another after being given an antihistamine such as diphenhydramine [ ]. Aggregates present in protein preparations may be the cause of some reactions. Another postulated cause may be the presence of antibodies against genetic variants of human albumin [ ]. Hypotensive reactions due to the presence of a prekallikrein activator in some batches of formulations can occur.
Albumin has been used to prevent the ovarian hyper-stimulation syndrome (OHSS) associated with ovulation stimulation. In 98 women albumin had no positive effect on OHSS [ ]. Because of adverse effects, such as exacerbation of ascites in OHSS, nausea, vomiting, febrile reactions, allergic reactions, anaphylaxis, and the risk of pathogen transmission, albumin should not be used to prevent OHSS.
Human serum albumin has a very low incidence of immediate adverse effects [ ]. Allergic and febrile reactions have been reported, but are very rare and tend to be brand-specific, lot-specific and/or patient-specific.
Adverse events during plasma exchanges in 28 adults with Guillain–Barré syndrome have been described in a study of 28 French and Swiss intensive care units [ ]. The study was based on 220 patients allocated either to plasma exchange or not. A total of 105 patients underwent 390 plasma exchanges (55 received albumin in 208 sessions as replacement fluid and 50 received fresh plasma in 182 sessions). Altogether, 253 adverse incidents were recorded, and in 15 patients plasma exchange had to be discontinued because of severe intolerance, which included bradycardia (n = 3), intercurrent complications (mainly infections), and technical difficulties. Fresh frozen plasma was associated with significantly more adverse incidents than albumin. The occurrence of adverse events was related to the preplasma exchange hemoglobin. Age, sex, previous history, neurological severity, and the need for mechanical ventilation did not modify the risk of adverse effects. The possibility that some of the events described in this series were attributable to the underlying disease rather than to the plasma exchange was not ruled out.
Drug studies
Observational studies
In a prescription monitoring study in three hospitals of 187 patients who received 426 prescriptions for a total of 21 094 g of albumin for hypoalbuminemia, plasmapheresis, and ascites or hepatorenal syndrome, no adverse events were attributed to albumin [ ].
Comparative studies
In a randomized study in which 67 patients with hepatic cirrhosis and hepatorenal syndrome were given intravenous terlipressin 1–2 mg 4-hourly + albumin 1 g/kg followed by 20–40 g/day was compared with albumin alone [ ]. Adverse events in the two groups included myocardial ischemia, dysrhythmias, intestinal ischemia, circulatory overload, bacterial infections, hepatic encephalopathy, and arterial hypertension, among others. There was no statistical difference in the incidences of adverse events, but the authors noted that this is a population that is susceptible to severe complications.
Systematic reviews
A systematic review of 25 randomized clinical trials of hyperoncotic albumin in 1485 patients has suggested that it might increase the risk of pulmonary edema and capillary leak. However, it is uncertain whether this was a risk of albumin per se or of fluid overload [ ].
Organs and systems
Cardiovascular
Albumin infusions can increase capillary permeability [ ] and albumin infusion during resuscitation can result in hypervolemia, due to overfilling of the circulation [ ].
It has been postulated that cardiac pump function can be reduced by binding of free calcium to albumin [ ].
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