Update: Antidepressant Renamed to Avoid Confusion with Brilinta
May 3, 2016 – Following a July 2015 Drug Safety Communication that warned about name confusion between the antidepressant Brintellix (generic: vortioxetine) and Brilinta which resulted in prescribing errors, Brintellix is changing its name to Trintellix, according to the U.S. Food and Drug Administration (FDA). The drug with its new brand name is expected to be available in June 2016.
What is Brilinta?
Brilinta is a blood thinner (anticoagulant) medication used to lower the risk of stroke or serious heart problems in patients who have suffered a heart attack or severe chest pain (angina). The drug’s mechanism of action prevents platelets in the blood from sticking together and forming a blood clot. Brilinta is made by AstraZeneca, and was approved by the U.S. Food & Drug Administration (FDA) in July 2011.
Problems Found in PLATO Trial Results
Doctors and researchers are concerned that AstraZeneca may have submitted false data to the FDA in order to gain approval for Brilinta in the U.S. This led to a federal investigation into the validity of the PLATO study upon which the FDA relied on to approve Brilinta.
In April 2013, the International Journal of Cardiology published a study which claimed that data irregularities in the PLATO trial made Brilinta appear safer than it actually is. Specifically, the study’s authors claim that AstraZeneca omitted information regarding deaths and other adverse events associated with the drug:
“An estimated 23 definite or possible cardiovascular events or deaths on ticagrelor (Brilinta) were either not submitted for adjudication, inactivated, deleted or were downgraded to ‘softer’ endpoints,” the researchers concluded.
In the PLATO study, Brilinta was compared to Plavix, a competing blood thinner made by Bristol-Myers Squibb in conjunction with Sanofi Pharmaceuticals. Researchers paid by AstraZeneca allegedly reported that side effects were more frequent and problematic with Plavix than with Brilinta. However, multiple experts have subsequently pointed out gaps in the study which could result in serious injury and even death to patients who use Brilinta.
Brilinta Side Effects
- Heart attack
- Internal bleeding
- Rectal bleeding
- Cerebral hemorrhage
- Digestive tract ulcers
- Kidney failure
- Pulmonary embolism
- Deep vein thrombosis (DVT)
The most commonly reported side effects of Brilinta are bleeding and difficult or labored breathing (dyspnea). In the PLATO study, 9235 patients were treated with the 90 mg oral dose of Brilinta twice daily. Patients were evaluated for non-CABG related major or minor bleeds compared to patients treated with Plavix (n=9186).
A minor bleed required medical intervention, whereas a major bleed included one or more of the following: fatal, intracranial, intrapericardial with cardiac tamponade, hypovolemic shock or severe hypotension requiring intervention, significantly disabling, a decrease in hemoglobin of at least 3 g/dL, or a transfusion of 2 or more units.
For Brilinta, the incidence of major and minor bleeds was 7.7% (vs. Plavix 6.2%). These results were further broken down as: Major bleed (3.9%) major bleed fatal/life threatening (1.9%), fatal (0.2%), and intracranial hemorrhage fatal/life threatening (0.3%). About half of the non-CABG major bleeding events occurred within the first 30 days of treatment with Brilinta.
When antiplatelet therapy was stopped 5 days prior to CABG, major bleeding occurred in 75% and 79% of patients treated with Brilinta or Plavix, respectively.
Is There an Antidote?
There is currently no known antidote that can stop Brilinta bleeding events. However, a new drug called MED 12452 is being developed to reverse the anti-clotting effects of Brilinta in case of emergency, according to MD Magazine. AstraZeneca researchers claim MED 12452 “specifically binds to ticagrelor and tricagrelor active metabolite with high affinity,” and “neutralizes the plasma unbound fraction of ticagrelor and reverses ticagrelor mediated inhibition of platelet aggregations in vitro.”
Has There Been a Recall?
To date, no recall has been issued for Brilinta in the U.S. or any other country. However, due to reports of serious side effects and manipulated trial data, it is anticipated that product liability lawsuits will allege that AstraZeneca failed to adequately warn of the potential dangers associated with Brilinta. If you or someone you love has been injured, contact our lawyers today to learn more about your legal rights.