Trasylol (aprotinin injection) Heart Attack, Stroke & Liver Toxicity.
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Trasylol (aprotinin injection) Diabetes & Hyperglycemia Lawsuit Information: Side Effects And Precautions

Hypersensitivity or pseudo-allergic reactions can occur, not only after repeated courses of treatment but also with first administration. Prophylactic measures are described under DOSAGE AND DIRECTIONS FOR USE.

The symptoms of anaphylactic or anaphylactoid reactions may extend from:

  • itching
  • rash
  • sweating
  • flush
  • urticaria
  • skin eruptions
  • pallor or cyanosis
  • dyspnoea
  • nausea
  • drop in blood pressure
  • tachycardia or bradycardia and airway obstruction

. . . to severe hypotension and anaphylactic shock with, in rare cases, fatal outcome.

If a hypersensitivity reaction occurs during the injection or infusion, administration should be stopped immediately and the appropriate therapeutic measures instituted e.g. adrenaline, antihistamines and intravenous corticosteroids. Intravenous fluids, bronchodilators and respiratory support may also be needed. Post-operative renal dysfunction has been reported [emphasis added].

An increase in renal failure and mortality compared to age-matched historical controls has been reported for aprotinin-treated patients undergoing cardiopulmonary bypass with deep hypothermic circulatory arrest during operation of the thoracic aorta.

TRASYLOL should therefore be used with extreme caution under these circumstances. Adequate anticoagulation with heparin must be assured. Increases of serum creatinine have been observed in clinical studies.

During post-marketing surveillance cases of kidney failure have been reported.

In two clinical studies with repeated cardiopulmonary bypass surgery it has been observed that there was an increased incidence of perioperative, fatal/non-fatal myocardial infarction in the aprotinin groups compared to the placebo treated controls.

In a multi-centre study in patients undergoing primary coronary artery bypass graft surgery there was an increased risk of graft closure for TRASYLOL treated patients compared to patients who received placebo. No differences between the treatment groups were observed for the incidence of myocardial infarctions or of deaths in this study. Local thrombophlebitic reactions may occur after TRASYLOL injections or infusions.

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Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred.

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