Brilinta Lawsuit | 2026 Latest Updates

Brilinta carries an FDA boxed warning for significant, sometimes fatal bleeding. In June 2025, The BMJ reported data concerns in two studies behind ticagrelor, AstraZeneca’s blood thinner. Peter Doshi’s investigation covered the ONSET/OFFSET and RESPOND studies. Brilinta is sold as 60 mg and 90 mg tablets. No consumer lawsuit, class action or MDL names it in the United States. People take the drug to lower the risk of heart attack and stroke. A Department of Justice review of the PLATO trial, which followed allegations of unreported adverse events, closed in 2014 with no further action planned. A 2017 recall of one lot of sample bottles is completed.

Latest Brilinta Lawsuit Updates

June 20, 2025: Medscape Reports on BMJ Investigation of Ticagrelor Studies

Medscape reported on a BMJ investigation by Peter Doshi, PhD, into two studies behind Brilinta, ONSET/OFFSET and RESPOND. It raised concerns about the data in both studies [1]. AstraZeneca and the journal Circulation declined to comment or could not be reached, according to The BMJ.

March 29, 2025: Pharmacy Times Reports Data on a Ticagrelor Antidote

Pharmacy Times reported data from ACC 2025 on bentracimab, an antidote to ticagrelor, the drug in Brilinta. In the REVERSE-IT study, it reversed the antiplatelet effects of ticagrelor [2]. Earlier interim data showed the effect within 5 to 10 minutes. The study was presented by Bhatt, and the trial had no control group.

May 24, 2017: AstraZeneca Recalls One Lot of Brilinta Sample Bottles

AstraZeneca announced a voluntary nationwide recall of one lot of Brilinta 90 mg professional sample bottles, lot JB5047. The FDA posted the recall on February 8, 2018 [3]. AstraZeneca said it had received no adverse event reports related to this recall. The FDA states the recall is completed and terminated.

November 13, 2014: Fierce Pharma Reports an Antidote Program

Fierce Pharma reported that AstraZeneca had launched a preclinical development program on a potential Brilinta antidote. The report named the antidote candidate MEDI2452. The program was still before any testing in people [4].

August 19, 2014: Justice Department Closes Its PLATO Trial Probe

Reuters, via Fox News, reported that the Department of Justice was closing its probe into the PLATO study. AstraZeneca said no further action was planned [5]. The probe covered the 18,000-patient study. The PLATO principal investigator, Lars Wallentin, strongly defended the integrity of the study.

What Is Brilinta?

According to the FDA prescribing information, Brilinta is a P2Y12 platelet inhibitor. The FDA approved it in the United States in 2011 [6]. The label lists it to reduce the risk of cardiovascular death, heart attack and stroke in adults with acute coronary syndrome.

Who May Be Affected?

Brilinta is prescribed to adults with acute coronary syndrome or a history of heart attack. It is also prescribed to adults with coronary artery disease at high risk of a first heart attack or stroke. Adults with acute ischemic stroke or high-risk transient ischemic attack may also take it. The same FDA label says not to use Brilinta in patients with active pathological bleeding or a history of intracranial hemorrhage. Your own facts decide whether a claim exists. That takes an individual legal review of your medical records, your prescription history and the bleeding event.

Reported Injuries or Damages

The FDA label warns that Brilinta, like other antiplatelet agents, can cause significant, sometimes fatal bleeding. This is labeled risk information. It is not an allegation in a lawsuit. The BMJ investigation reported by Medscape is a separate matter. Peter Doshi found the RESPOND primary endpoint was statistically nonsignificant (P = .157). Circulation later reported it as significant (P = .005). Doshi reported that an undeclared change in the endpoint definition accounts for the difference. Doshi also found that more than 60 of 282 platelet-test readings were missing from the datasets sent to the FDA. These are Doshi’s reported findings and claims. Neither a court nor the FDA has made them.

Recall and Regulatory Background

The recall covered only 8-count professional sample bottles. AstraZeneca acted after a report that one bottle also held Zurampic (lesinurad) 200 mg tablets. Other forms and strengths of Brilinta were not affected. That includes medicine from US retail or mail-order pharmacies. One recalled lot does not prove liability for bleeding injuries.

Evidence to Preserve

If you had serious bleeding while taking Brilinta, keep these items:

• Pill bottles and pharmacy records showing dates and doses
• Prescriptions and the prescriber’s name
• Hospital, emergency and imaging records of any bleeding event
• Medication guides and instructions you received
• Photos of injuries
• Receipts and bills
• A log of symptoms and your communications with doctors or AstraZeneca

Filing Deadlines

Filing deadlines come from state law. They differ depending on where you live and when the injury and its link to a drug were discovered. Miss a deadline and the claim may end, however strong the facts. Ask a lawyer promptly how the timing rules apply to you.

Frequently Asked Questions

What Does the Research Say About a Brilinta Antidote?

What does the research say about a Brilinta antidote? Bentracimab reversed ticagrelor’s effects in the REVERSE-IT trial. Pharmacy Times reported that 94.3% of patients achieved normal hemostasis. The trial had no control group.

Can I Stop Taking the Drug If I Am Worried?

Can you stop taking Brilinta if you are worried? Do not stop without talking to your prescribing doctor. Missed doses raise the risk of heart attack and stroke. People with a stent who miss doses face a higher risk of a blood clot in the stent, heart attack or death.

Has Brilinta Ever Been Recalled?

Has Brilinta ever been recalled? Yes. Physicians in the United States received the recalled sample bottles between March and April of 2017. The 2017 notice listed the AstraZeneca Information Center at 1-800-236-9933, 8 a.m. to 6 p.m. Eastern Time, Monday to Friday.

What Are the Dangerous Side Effects of Brilinta?

The dangerous side effects of Brilinta include significant, sometimes fatal bleeding, according to its FDA label. The label says to manage bleeding without discontinuing Brilinta if possible. It also says not to start Brilinta in patients undergoing urgent CABG surgery.

References

1. https://www.medscape.com/viewarticle/investigation-bmj-raises-more-concerns-about-ticagrelor-2025a1000gh3
2. https://www.pharmacytimes.com/view/acc-2025-ticagrelor-antidote-restores-platelet-function-treats-bleeding
3. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/astrazeneca-initiates-voluntary-nationwide-recall-one-lot-brilinta-90-mg-professional-sample-bottles
4. https://www.fiercepharma.com/sales-and-marketing/astrazeneca-eyes-a-clotting-antidote-to-its-growth-hopeful-brilinta
5. https://www.foxnews.com/health/u-s-clears-astrazeneca-over-heart-drug-trial.amp
6. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022433s035lbl.pdf