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HEXTEND Adverse Reactions (6% Hetastarch in Lactated Electrolyte Injection)

ADVERSE REACTIONS

Serious adverse reactions reported in postmarketing clinical trials include increased mortality and AKI (including need for RRT) in critically ill subjects, including subjects with sepsis, and surgical subjects. Clinical trials have also shown increased mortality and AKI in blunt trauma subjects. Increased coagulopathy was reported in surgical subjects.

In clinical trials comparing the plasma volume expanding properties of HEXTEND (n=60) with those of 6% Hetastarch in 0.9% Sodium Chloride Injection (n=59), there were no significant differences in the number of adverse or serious adverse events between the two groups.

Reported adverse reactions with isotonic solutions containing 6% hetastarch include:

General

Hypersensitivity (see WARNINGS AND PRECAUTIONS).

Death, life-threatening anaphylactic/anaphylactoid reactions, cardiac arrest, ventricular fibrillation, severe hypotension, non-cardiac pulmonary edema, laryngeal edema, bronchospasm, angioedema, wheezing, restlessness, tachypnea, stridor, fever, chest pain, bradycardia, tachycardia, shortness of breath, chills, urticaria, pruritus, facial and periorbital edema, coughing, sneezing, flushing, erythema multiforme, and rash.

Cardiovascular

Circulatory overload, congestive heart failure, and pulmonary edema (see WARNINGS AND PRECAUTIONS).

Hematologic

Intracranial bleeding, bleeding and/or anemia due to hemodilution (see WARNINGS AND PRECAUTIONS) and/or Factor VIII deficiency, acquired von Willebrand's-like syndrome, and coagulopathy including rare cases of disseminated intravascular coagulopathy and hemolysis. With extensive clinical use of 6% Hetastarch in 0.9% Sodium Chloride Injection, rare cases of disseminated intravascular coagulopathy and hemolysis have been observed.

Metabolic

Metabolic acidosis.

Other

Vomiting, peripheral edema of the lower extremities, submaxillary and parotid glandular enlargement, mild influenza-like symptoms, headaches, and muscle pains. Hydroxyethyl starch-associated pruritus has been reported in some patients with deposits of hydroxyethyl starch in peripheral nerves.

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