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Aprotinin Side Effects

For the Consumer

Applies to aprotinin: parenteral injection

Side effects include:

Atrial fibrillation, hypotension, MI, atrial flutter, ventricular extrasystoles, tachycardia, ventricular tachycardia, heart failure, pericarditis, peripheral edema, fever, infection, nausea, lung disorder, pleural effusion, atelectasis.

For Healthcare Professionals

Applies to aprotinin: intravenous solution

General

In general, aprotinin was generally well tolerated in clinical studies with 76% of patients receiving aprotinin reporting an adverse effect vs. 77% of patients receiving placebo therapy. The side effects reported in these clinical studies were ones which are frequently associated with cardiac surgery thus making it difficult to determine a definite causal relationship with aprotinin.[Ref]

Hypersensitivity

A retrospective review of patient records with documented reexposure to aprotinin reported a 2.7% incidence in hypersensitivity/anaphylactic reactions. Two patients, out of 387 records reviewed, died 24 hours and 5 days after experiencing a hypersensitivity/anaphylactic reaction, respectively. A causal relationship with aprotinin was not determined. This review also reported the chance of a hypersensitivity/anaphylactic side effect is approximately 5% in cases where reexposure occurs within 6 months of initial aprotinin administration, and approximately 0.9% for reexposure greater than 6 months from initial administration.[Ref]

Hypersensitivity side effects have included skin eruptions, itching, dyspnea, nausea, tachycardia and fatal anaphylactic shock with circulatory failure.[Ref]

Cardiovascular

Cardiovascular side effects for aprotinin in relation to placebo therapy have included atrial fibrillation (21% vs. 23%), hypotension (8% vs. 10%), myocardial infarct (6% each), atrial flutter (6% vs. 5%), ventricular extrasystoles(6% vs. 4%), tachycardia (6% vs. 7%), ventricular tachycardia (5% vs. 4%), heart failure (5% vs. 4%), pericarditis (5% each), peripheral edema (5% each), hypertension (4% vs. 5%), arrhythmia (4% vs. 3%), supraventricular tachycardia (4% vs. 3%), atrial arrhythmia (3% each), thrombosis (1% vs. 0.6%), shock (0.7% vs. 0.4%), cerebrovascular accident (0.7% vs. 2.1%), thrombophlebitis (0.2% vs. 0.5%), and deep thrombophlebitis (0.7% vs. 1%). Ventricular fibrillation, heart arrest, bradycardia, congestive heart failure, hemorrhage, bundle branch block, myocardial ischemia, ventricular tachycardia, heart block, pericardial effusion, ventricular arrhythmia, shock, and pulmonary hypertension have been reported in 1% to 2% of patients. Occlusion of vascular grafts, including coronary-bypass grafts, has also been reported.[Ref]

In addition to being reported in clinical trials, thrombosis has been reported in uncontrolled trials, compassionate use trials, and spontaneous postmarketing reporting. In these reports the term thrombosis was used to describe any one of the following conditions: thrombosis, occlusion, arterial thrombosis, pulmonary thrombosis, coronary occlusion, embolus, pulmonary embolus, thrombophlebitis, deep thrombophlebitis, cerebrovascular accident, and cerebral embolism.

Myocardial infarction is reported to have an incidence of 5.9% in patients treated with aprotinin versus 4.7% in patients treated with placebo. This difference in incidence rates is not statistically significant.

A multicenter, multinational study reported an increase in the risk of graft closure (p=0.035) in patients undergoing primary CABG surgery treated with aprotinin versus placebo. However, when the study was repeated in U.S. centers only, there was no statistically significant difference in graft closure rates of aprotinin treated patients versus patients treated with placebo.[Ref]

Other

Other side effects for aprotinin in relation to placebo therapy have included fever (15% vs. 14%), infection (6% vs. 7%), and chest pain (2% each). Sepsis, death, multi-system organ failure, and immune system disorder have been reported in 1% to 2% of patients. Hemoperitoneum has also been reported.[Ref]

Hematologic

Hematologic side effects for aprotinin in relation to placebo therapy have included anemia (2% vs. 8%). Leukocytosis, thrombocytopenia, coagulation disorder (including disseminated intravascular coagulation), and decreased prothrombin have been reported in 1% to 2% of patients. In addition, severe diffuse venous thromboembolism has been associated with aprotinin administration in patients positive for factor V Leiden.[Ref]

Respiratory

Respiratory side effects for aprotinin in relation to placebo therapy have included lung disorder (8% each), pleural effusion (7% vs. 9%), atelectasis (5% vs. 6%), dyspnea (4% each), pneumothorax (4% each), asthma (2% vs. 3%), hypoxia (2% vs. 1%), lung edema (1.3% vs. 1.5%), and pulmonary embolus (0.3% vs. 0.6%). Pneumonia, apnea, increased cough, and lung edema have been reported in 1% to 2% of patients.[Ref]

Renal

Renal side effects for aprotinin in relation to placebo therapy have included abnormal kidney function (3% vs. 2%), kidney failure (1% vs. 0.6%), acute kidney failure (0.5% vs. 0.6%), and kidney tubular necrosis (0.8% vs. 0.4%).[Ref]

Metabolic

Metabolic side effects for aprotinin in relation to placebo therapy have included increase in creatine phosphokinase (2% vs. 1%). Hyperglycemia, hypokalemia, hypervolemia and acidosis have been reported in 1% to 2% of patients.[Ref]

Hepatic

Hepatic side effects for aprotinin in relation to placebo therapy have included abnormal liver function tests (3% vs. 2%). Jaundice and hepatic failure have also been reported in 1% to 2% of patients.[Ref]

Nervous system

Nervous system side effects for aprotinin in relation to placebo therapy have included confusion (4% each), insomnia (3% vs. 4%), and asthenia (2% each). Agitation, dizziness, anxiety, and convulsion have been reported in 1% to 2% of patients.[Ref]

Musculoskeletal

Nonspecific musculoskeletal side effects have been reported in 2% of patients receiving aprotinin versus 3% receiving placebo therapy. Arthralgia has been reported in 1% to 2% of patients receiving aprotinin.[Ref]

Gastrointestinal

Gastrointestinal side effects for aprotinin in relation to placebo therapy have included nausea (11% vs. 9%), constipation (4% vs. 5%), vomiting (3% vs. 4%) and diarrhea (3% vs. 2%). Dyspepsia and gastrointestinal hemorrhage have been reported in 1% to 2% of patients.[Ref]

Genitourinary

Genitourinary side effects for aprotinin in relation to placebo therapy have included urinary retention (3% each) and urinary tract infection (2% each). Oliguria has been reported in 1% to 2% of patients.[Ref]

Dermatologic

Dermatologic side effects for aprotinin in relation to placebo therapy have included rash (2% each). Skin discoloration has also been reported.[Ref]

References

1. "Product Information. Trasylol (aprotinin)." Bayer, West Haven, CT.

2. Underwood MJ, Cooper GJ "Aprotinin and vein graft occlusion after coronary artery bypass." J Thorac Cardiovasc Surg 109 (1995): 1022-3

3. Shore-Lesserson L, Reich DL "A Case of Severe Diffuse Venous Thromboembolism Associated with Aprotinin and Hypothermic Circulatory Arrest in a Cardiac Surgical Patient with Factor V Leiden." Anesthesiology 105 (2006): 219-221

Not all side effects for aprotinin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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