News | October 20, 2010

FDA Approves Stroke Prevention Drug in Atrial Fibrillation Patients

October 20, 2010 - The U.S. Food and Drug Administration (FDA) approved a new drug to help prevent stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). Pradaxa (generic: dabigatran etexilate), by Boehringer Ingelheim Pharmaceuticals, will be available in 75 mg and 150 mg capsules.

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.

“People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa.”

As with other approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, was among the most common adverse reactions reported. Gastrointestinal symptoms, including an uncomfortable feeling in the stomach (dyspepsia), stomach pain, nausea, heartburn and bloating also were reported.

For more information: www.pradaxa.com

Related Content

Icosapent Ethyl (Vascepa) significantly Reduces Revascularizations in Statin Patients in the REDUCE-IT REVASC analyses presented as a late-breaking study at SCAI 2020. Photo by Dave Fornell

Icosapent Ethyl (Vascepa) significantly reduces revascularizations in statin patients based on data from the REDUCE-IT REVASC analyses, presented as a late-breaking study at SCAI 2020. Photo by Dave Fornell

News | Pharmaceuticals | May 17, 2020
May 17, 2020 – Patients with high lipid levels have an increased risk for ischemic events, despite statin therapy.
Scott Wright, M.D., Mayo Clinic, presenting the results at ACC on the two-dose a year LDL-lowering drug inclisiran, which had a significant reduction in LDL in the ORION Trial. #ACC20 #ACC2020

Scott Wright, M.D., Mayo Clinic, presenting the results at ACC on the two-dose a year LDL-lowering drug inclisiran, which had a significant reduction in LDL in the ORION Trial.

News | Pharmaceuticals | March 28, 2020 | Dave Fornell, Editor
March 28.
The U.S. Food and Drug Administration (FDA) approved Esperion's bempedoic acid (Nexletor) tablet, an oral, once-daily, non-statin low-density lipoprotein cholesterol (LDL-C) lowering medicine. The drug is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C. 
Feature | Pharmaceuticals | February 24, 2020
February 24, 2020 — The U.S.
This image shows the cardiac muscle fibers of a fruit fly under magnification. Iowa State University researchers have found a way to restore the strength and regularity of cardiac muscles in aging fruit flies. Photo by Hua Bai, Iowa State University.

This image shows the cardiac muscle fibers of a fruit fly under magnification. Iowa State University researchers have found a way to restore the strength and regularity of cardiac muscles in aging fruit flies. Photo by Hua Bai, Iowa State University.

News | Pharmaceuticals | January 09, 2020
January 9, 2020 – Researchers may have discovered a way to turn back the clock on aging heart muscles in fruit flies,
 Christie Ballantyne

Dr. Christie Ballantyne, professor of medicine and chief of the section of cardiology at Baylor College of Medicine

News | Pharmaceuticals | December 30, 2019
December 30, 2019 — A drug therapy targeting the production of a protein produced by the liver has led to sustained a
Vascepa pill contains a concentrated form of fish oil, icosapent ethyl, indication for prevention. The U.S. Food and Drug Administration (FDA) Dec. 13, 2019, approved the use of Vascepa (icosapent ethyl) capsules as an adjunctive therapy to reduce the risk of cardiovascular events in adults with elevated triglyceride levels.
Feature | Pharmaceuticals | December 16, 2019 | Dave Fornell, Editor
The U.S. Food and Drug Administration (FDA) approved the use of Vascepa (icosapent ethyl) capsules as an adjunctive...
Coronary CT angiography images of a coronary artery depicting the perivascular fat attenuation index (FAI) before and after biologic therapy at one-year follow-up. Patients had excellent response to biologic therapy, showing clear reductions in the inflammation in plaques that cause heart attacks and stokes. Image from the Oxford Academic Cardiovascular CT Core Lab and Lab of Inflammation and Cardiometabolic Diseases at NHLBI.

Coronary CT angiography images of a coronary artery depicting the perivascular fat attenuation index (FAI) before and after psoriasis biologic drug therapy at one-year follow-up. Patients had excellent response to biologic therapy, showing clear reductions in the inflammation in plaques that cause heart attacks and stokes. Image from the Oxford Academic Cardiovascular CT Core Lab and Lab of Inflammation and Cardiometabolic Diseases at NHLBI.

 

Feature | Pharmaceuticals | July 31, 2019
July 31, 2019 — Researchers found anti-inflammatory drug therapies used to treat moderate to severe psoriasis can sig
Quantum Genomics Enrolls First Patient in QUORUM Phase IIb Study of Firibastat
News | Pharmaceuticals | June 14, 2019
Quantum Genomics announced the enrollment of the first patient in its QUORUM Phase IIb study of its lead clinical...
FDA Grants Priority Review for Vascepa sNDA
News | Pharmaceuticals | May 29, 2019
Amarin Corp. plc announced that its supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules has...