AstraZeneca has been accused of manipulating trial data regarding the side effects of Brilinta (generic: ticagrelor), a prescription blood thinner medication. The company was investigated by the U.S. Justice Department for allegedly downplaying and even hiding information about heart problems linked to Brilinta in a late-stage clinical trial known as PLATO.
Brintellix to be Renamed After Confusion with Brilinta led to Errors
May 6, 2016 - The brand name for the antidepressant Brintellix (generic: vortioxetine) will be changed in order to avoid confusion with Brilinta, according to the U.S. Food & Drug Administration (FDA). Brintellix will now be marketed as Trintellix. FDA hopes the name change will decrease the risk for medication errors associated with the confusion.
Last year, the agency announced that it had received at least 50 reports of such medication errors since Brintellix was approved in 2013; in some cases, the wrong drug was dispensed. The transition to Trintellix will begin in June; patients and providers may still see Brintellix labels until the change is complete.
What is Brilinta?
Brilinta keeps blood platelets from clotting (coagulating) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions. The medication is used to lower the risk of stroke or serious heart problems after a patient has had a heart attack or severe chest pain (angina). Brilinta is made by AstraZeneca, and was approved by the FDA in July 2011.
Adverse Event Data Skewed in Brilinta Clinical Trial: DOJ
The PLATO trial was the subject of an investigation by the U.S. Justice Department following a report in the International Journal of Cardiology which claimed that data regarding adverse events and deaths had been omitted from submissions made to the FDA. The report, entitled “Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: Serious concerns over the reliability of the PLATO trial,” found a number of irregularities which raised suspicion that AstraZeneca had altered data to make Brilinta appear safer than it actually is.
Specifically, an independent review determined that 46% of all primary endpoint events favoring Brilinta came from just 2 countries, Poland and Hungary, despite participation from test subjects in numerous other countries. The review also found that heart attacks associated with Brilinta were under-reported in PLATO’s findings.
“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,” said James DiNicolantonio, Pharm.D., and Dr. Ales Tomek.
PLATO compared Brilinta to its major competitor, Plavix (generic: clopidogrel bisulfate), and found that problems with Plavix were reported more harshly and more frequently than with Brilinta. Beyond those involved in the trial, Brilinta users from the general public could be at risk. If the medication was approved based on incorrect data, prescribing doctors may be lacking a full understanding of the potential health risks associated with Brilinta.
The Justice Department concluded its investigation in August 2014 and "is not planning any further action," according to a statement by AstraZeneca.
Brilinta Side Effects
Brilinta has been linked to the following serious side effects:
- Heart attack
- Internal bleeding
- Rectal bleeding
- Cerebral hemorrhage
- Digestive tract ulcers
- Kidney failure
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
Other, more moderate side effects may include:
- Shortness of breath
- Nosebleeds or other unusual bleeding that will not stop
- Bloody or tarry stools
- Blood in the urine
- Chest pain
- Sudden numbness or weakness, especially on one side of the body
- Vision problems
- Pale skin or jaundice (yellowing of the skin or eyes)
- Easy bruising
According to the FDA Medication Guide, Brilinta "can cause bleeding events that can be serious and sometimes lead to death." These types of bleeding events may result in the need for a blood transfusion or surgery.
If you are a Brilinta user, you may be at an increased risk for:
- Bruising and bleeding more easily
- Frequent nose bleeds
- Bleeding events that take longer to stop
Contact your doctor immediately if you are a Brilinta user who has any of the following symptoms:
- Uncontrollable bleeding
- Pink, red or brown urine
- Vomiting blood or have vomit that looks like coffee grounds
- Red or black stools
- Coughing up blood or blood clots
Does Brilinta have an Antidote?
In November 2014, FiercePharma announced that AstraZeneca had launched a pre-clinical development program on a potential Brilinta antidote called MEDI2452. The drug is designed to reverse Brilinta's anti-clotting properties in case of a bleeding emergency.
"In certain emergencies, doctors need to have the option to swiftly reverse the effects of oral antiplatelet agents … without having to wait for the effects of the medicine to wear off," said Brilinta global development lead Marc Ditmarsch. "[W]e believe MEDI2452 has the potential to help address this need for patients treated with Brilinta."
Brilinta is known to interact with at least 455 other medications, or a total of 1791 brand and generic names, including:
- 73 major drug interactions (239 brand and generic names)
- 298 moderate drug interactions (1121 brand and generic names)
- 84 minor drug interactions (431 brand and generic names)
Has There Been a Recall?
To date, Brilinta has not been recalled in the U.S. or any other country. However, the investigation into the drug is still in its early stages, and patients who have been injured may be able to file a product liability lawsuit against the manufacturer. If our lawyers determine that you have a valid claim, you may be awarded a settlement to help with medical expenses, lost wages, pain and suffering, and more. Contact us today to learn more about your legal rights.
Is There a Class Action?
There is currently no class action lawsuit pending in the Brilinta litigation. However, if multiple lawsuits are filed against the manufacturer over injuries allegedly caused by the drug, the cases may be consolidated into a multidistrict litigation (MDL) for pretrial handling. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims associated with allegedly defective pharmaceutical products.