Bleeding is the most common side effect of Brilinta, but it was sold for years without a reversal agent. After a major injury or before an unexpected surgery, doctors must be able to deactivate any blood-thinning medications. The longer it takes to stop bleeding, the higher the risk of death.
AstraZeneca’s blood-thinning drug Brilinta (ticagrelor) causes bleeding in about 12% of patients, according to clinical trial data. Brilinta does not “thin” the blood, but actually prevents red blood cells (platelets) from sticking together. This stops blood clots from forming or growing larger, but also significantly increases a patient’s risk of bleeding.
What is the problem?
The problem is that when bleeding starts — either spontaneously or after an injury — patients can bleed uncontrollably because Brilinta does not have a reversal agent. The lack of an antidote can also be a problem for patients who suddenly need surgery.
AstraZeneca Starts Developing Antidote
In November 2014, Reuters reported that AstraZeneca was developing an antibody treatment to counteract Brilinta. According to the drug-maker:
“In certain emergencies, doctors need to have the option to swiftly reverse [Brilinta] to enable emergency surgery or a quick response to a major bleeding event without having to wait for the effects of the medicine to wear off. Currently there are no FDA approved medications to counteract the anti-platelet effect in these situations.”
Complications of Severe Bleeding
The longer it takes to stop bleeding, the higher the risk of hypovolemic shock, a complication that occurs in patients who lose at least 20% of their blood. During shock, blood pressure plummets. When vital organs lose their blood supply, they stop working and become permanently damaged. This can lead to life-threatening complications, including:
- Kidney failure
- Brain damage
- Gangrene (necrosis) or arms and legs, may require amputation
- Heart attack
- Organ damage
Brilinta Bleeding “Black Box” Warning Label
The Prescribing Information (PDF) for Brilinta carries a “Black Box” warning about the risk of severe, sometimes fatal bleeding. It also warns that Brilinta becomes less effective when patients take more than 100-mg of aspirin.
Warnings & Contraindications
- Actively bleeding patients should not take Brilinta
- Patients with a history of cerebral hemorrhage (bleeding in the brain) should not take Brilinta
- If possible, bleeding should be treated without discontinuing Brilinta, because doing so increases the risk of heart attack, stroke, and death.
- Brilinta should not be started in patients undergoing surgery to improve blood-flow to the heart (coronary artery bypass graft surgery)
What Should I Do?
Patients on Brilinta should be aware of the symptoms of internal and external bleeding. They should seek emergency medical attention for serious injuries or symptoms of severe bleeding, such as:
- Blood loss that is heavy or does not stop
- Bad falls or head injuries
- Severe headache, confusion, weakness, numbness
- Coughing up blood
- Vomit is bloody or looks like coffee grounds
- Menstrual bleeding that is much heavier or longer than normal
- Urine is pink, red, or brown
- Stools are red or black and tarry
- Nosebleeds that are severe or frequent
- Gums that bleed heavily
- Unusual bruising, swelling, or discomfort
- Severe stomach ache