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Brilinta

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Brilinta is a blood-thinning medication that came to market in 2011. As is the case with some other new-generation anticoagulants, there is currently no approved antidote to reverse internal bleeding that sometimes occurs with the use of Brilinta. The drug has also come under scrutiny due to accusations that AstraZeneca may have skewed results of a Brilinta clinical trial.

What is Brilinta?

Brilinta is a type of blood thinner known as a platelet aggregation inhibitor. It is indicated to:

• Prevent heart attack and stroke in people with heart problems (such as unstable angina or a previous heart attack)
• Prevent heart attack or stroke after certain heart surgeries (such as stent placement, coronary artery bypass graft-CABG, or angioplasty)

Brilinta is usually taken twice per day, and is used in conjunction with a once-daily low-dose aspirin. For the first 12 months of treatment, most patients will be prescribed 90mg Brilinta tablets. After 12 months, they may be transitioned to 60mg tablets.

AstraZeneca obtained U.S. Food & Drug Administration (FDA) approval for Brilinta in 2011. In 2013, the drug had logged worldwide sales of $283 million.

Brilinta Black Box Warning

The Brilinta label includes a Black Box Warning that, among other things, notes that the drug can cause episodes of severe and potentially fatal internal bleeding. Patients using Brilinta should contact their doctor immediately, if they experience:

• Severe, uncontrollable bleeding
• Pink, red, or brown urine
• Vomit that is bloody or looks like coffee grounds
• Red or black stool
• Coughing up blood or blood clots

Brilinta Safety Information

Brilinta should not be taken by patients who have a history of bleeding in the brain, are bleeding now, or are allergic to ticagrelor or any of the ingredients in the medication.

Brilinta may cause shortness of breath. Patients should contact their doctor if they experience any unexpected shortness of breath.

Brilinta may cause dizziness. Patients using this medication should not drive, use machinery, or do any activity that requires alertness until they are sure they can perform such activities safely.

Because Brilinta may cause stomach bleeding, patients should limit their use of alcoholic beverages. Consumption of alcohol may increase the risk of a stomach bleed.

Brilinta patients should check with their doctor if they experience any of the following:

• Difficult or labored breathing
• Shortness of breath
• Tightness in the chest
• Blurred vision
• Chest pain or discomfort
• Confusion
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fainting
• Fast or irregular heartbeat
• Headache
• Lightheadedness, dizziness, or fainting
• Loss of consciousness
• Nervousness
• Pounding in the ears
• Slow or fast heartbeat
• Sweating
• Unusual tiredness or weakness
• Bleeding gums
• Bruising
• Coughing up blood
• Difficulty with breathing or swallowing
• Headache, sudden and severe
• Increased menstrual flow or vaginal bleeding
• Nausea or vomiting
• Nosebleeds
• Paralysis
• Prolonged bleeding from cuts
• Red or black, tarry stools
• Red or dark brown urine
• Weakness

Brilinta Controversy

AstraZeneca obtained approval for Brilinta largely on the basis of PLATO, a clinical trial that involved 18,000 patients and compared Brilinta to its main competitor, Plavix. Overall, the study concluded that Brilinta-plus-aspirin was more effective than Plavix-plus-aspirin at preventing heart attack, stroke, and death.

In 2013, FDA reviewers writing in the International Journal of Cardiology raised serious concerns about the reliability of PLATO, due to what they said were irregularities with the study. That October, the U.S. Department of Justice opened an investigation into the clinical trial. However, the investigation ended one year later, with prosecutors taking no action.