Brilinta and Bleeding

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Bleeding is the most common side effect of the blood-thinner Brilinta, but it was sold for years without a reversal agent. In an emergency, patients could potentially bleed to death or suffer devastating complications while doctors struggle to deactivate it.

Overview

Brilinta (ticagrelor) is a blood-thinning medicine that helps prevent harmful blood clots from forming in the body. Brilinta also keeps existing blood clots from getting bigger. It does not actually “thin” the blood, but makes it harder for blood clots to form by preventing platelets from sticking together.

What is the problem?

Brilinta lacked an effective reversal agent when it was approved in 2011. In an emergency — such as before unexpected surgery or after a major injury — there is no time to wait for its blood-thinning effects to wear off. The longer it takes to stop bleeding, the higher the risk of serious complications or death. Unfortunately, patients may have been unaware of the lack of an antidote when they started taking Brilinta.

AstraZeneca Developing Reversal Agent

In November 2014, AstraZeneca announced that it would start developing an antibody treatment to reverse Brilinta.

Brilinta Bleeding “Black Box” Warning

Like most blood-thinners, bleeding is the most common side effect of Brilinta. About 12% of patients on Brilinta experience bleeding, according to clinical trials. The Prescribing Information (PDF) has a “Black Box” warning about severe, sometimes fatal bleeding. It also warns that doses of aspirin above 100-mg reduce the effectiveness of Brilinta and should be avoided.

Hypovolemic Shock

Hypovolemic shock is an emergency complication that occurs when severe blood-loss (20% or more) causes organs to stop working. During shock, blood pressure and body temperature plummet. This can cut off circulation to vital organs and cause severe complications, including:

  • Kidney failure
  • Brain damage
  • Gangrene of arms or legs, sometimes leading to amputation
  • Heart attack
  • Organ damage
  • Death

Bleeding Warnings & Contraindications

  • Brilinta should not be used by patients who are actively bleeding or have a history of intracranial hemorrhage (bleeding in the brain)
  • If possible, treat bleeding without discontinuing Brilinta because stopping it increases the risk of heart attack, stroke, and death.
  • Brilinta should not be started in patients undergoing coronary artery bypass graft surgery, which is used to improve blood-flow to the heart in patients with severe heart disease

When To Get Medical Attention

Patients on Brilinta should seek emergency medical attention for:

  • Bleeding that does not stop or is very heavy
  • Serious fall or head injury
  • Severe headache, confusion, weakness, or numbness
  • Coughing up blood
  • Vomit is bloody or looks like coffee grounds
  • Menstrual bleeding is much heavier or longer than normal
  • Urine is red or tea-colored
  • Bowel movements are red or back and tarry
  • Frequent nosebleeds
  • Heavy bleeding from the gums
  • Unusual bruising, swelling, or discomfort
  • Severe stomach ache

 

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