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stroke prevention 34 articles

Pradaxa maker fined for questionable marketing practices

Pradaxa

Boehring Ingelheim Pharmaceuticals will pay $95 million to settle allegations that it promoted three of its drugs for uses that were not approved by the Food and Drug Administration (FDA). The three drugs are the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease drug Combivent, and the hypertension drug Micardis. The Justice Department also said Boehring Ingelheim promoted the use of the chronic obstructive pulmonary disease drug Atrovent at doses higher than what was approved by drug regulators. The settlement with Boehring Ingelheim also resolved allegations that the drug company paid kickbacks to health care professionals to entice them to ... Read More

Study: Pradaxa has little impact on atrial fibrillation patients

Pradaxa

The blood thinner Pradaxa (abigatran) was quickly adopted after its approval into clinical practice for stroke prevention in patients with atrial fibrillation, but a team of researchers say that it has had little impact on its target population. Lead author Dr. G. Caleb Alexander, a research scientist in the Johns Hopkins Bloomberg School of Public Health, and colleagues used data from the IMS National Disease and Therapeutic Index to quantify patterns of oral anticoagulant – both Pradaxa and long-used warfarin – use among study participants from 2007 until 2011. They found that despite rapid adoption of Pradaxa for its approved ... Read More

Authors say FDA approved Pradaxa before safety was established

Pradaxa

An effort by the Food and Drug Administration (FDA) to expedite the approval of new drugs for serious medical conditions has allowed some medications to be cleared with inadequate testing to determine safety and efficacy, two drug safety experts claim in an article in the Journal of the American Medical Association. Thomas J. Moore, director of the drug safety publication QuatertWatch, and Curt D. Furberg, emeritus professor of medicine at Wake Forest University, say the FDA’s efforts to speed medications to patients have compromised prescription drug safety. One example they cite is the blood thinner Pradaxa, which was approved in ... Read More

Genetic test helps determine safer dosing of blood thinner

A genetic test is being used to determine the proper dosage of the blood thinner warfarin in patients at the University of Illinois Hospital & Health Sciences System. The medical center is one of the first in the nation to use genetic information in order to cater to individual patients’ specific dosages of a drug that ranks among the leading causes of drug-related adverse events. Warfarin is an anticoagulant that has been on the market for more than 50 years. It is used to treat deep vein thrombosis and pulmonary embolism and to prevent stroke in patients with atrial fibrillation ... Read More

Lawsuits claim Pradaxa never warned that bleeding side effects may not be reversible

The newly approved blood thinner Pradaxa works faster and requires fewer medical exams and dietary restrictions than the long-used warfarin, but it may result in dangerous and sometimes fatal internal bleeding events. Pradaxa was approved by the Food and Drug Administration (FDA) two years ago to prevent strokes in patients with a common heart condition known as atrial fibrillation. It was the first anticoagulant approved to treat atrial fibrillation patients since warfarin was cleared more than 50 years ago. Pradaxa was an attractive alternative to warfarin because there were fewer interactions and patients didn’t need to be as closely monitored. ... Read More

Kidney disease increases risk of stroke in atrial fibrillation patients

Kidney disease further increases the risk of stroke in patients with atrial fibrillation, according to a new study published in the New England Journal of Medicine. Atrial fibrillation is a common heart rhythm abnormality in which the upper chambers of the heart beat erratically, which makes it difficult for the blood to completely empty out of the heart chambers. This can cause the blood to pool and form into a clot. If the blood clot breaks loose and travels to the brain, it can cause a stroke. To reduce this risk in patients with atrial fibrillation, they are often prescribed ... Read More

Drug company responds to newspaper’s story about bleeding risks with Pradaxa

Pradaxa

On August 19, 2012, The Tennessean newspaper reported that two Tennessee men were among hundreds around the country who blame the new blood thinner Pradaxa for internal bleeding events. Four days later, the drug’s maker, Boehring Ingelheim Pharmaceuticals, fired back with a letter to the editor owning up to the bleeding risk but arguing that the newspaper article omitted the drug’s proven benefits. “The article failed to note that in a large clinical trial that involved more than 18,000 patients, Pradaxa was proven 36 percent better than warfarin at reducing the risk of stroke in patients with atrial fibrillation not caused ... Read More

Health Canada launches investigation into safety risks with Pradaxa

Pradaxa

Drug regulators in Canada are conducting a safety review on the new blood thinner Pradaxa (Dabigatran) after a study linked the medication to heart attacks. The drug is already under investigation by the U.S. Food and Drug Administration (FDA) because of serious bleeding events in patients who used the drug. In October 2010, both the FDA and Health Canada approved Pradaxa for stroke prevention in patients with a type of irregular heart rhythm known as atrial fibrillation. The drug was the first to win that indication since warfarin hit the market more than 50 years ago. Patients on warfarin must ... Read More

Pradaxa lawsuits may be combined in multi district litigation

Leeta Witt claims the new blood thinner Pradaxa caused her to suffer a cerebral hemorrhage that required two surgeries to resolve. Now, she is waiting to find out if her lawsuit against the manufacturer of the drug will be part of a Multi District Litigation. Witt’s lawsuit is one of about a dozen filed since May in the U.S. District Court for the Southern District of Illinois against Pradaxa’s maker Boehringer Ingelheim. Pradaxa was approved by the Food and Drug Administration (FDA) in 2010 to prevent strokes in patients with a type of irregular heart rhythm known as atrial fibrillation. ... Read More

Drug maker says it is working on antidote for risky blood thinner

Pradaxa

Boehringer Ingelheim, maker of the new blood thinner Pradaxa, says it is working on an antidote that will counter the effects of the medication in patients who use the drug but experience life-threatening internal bleeding events. Pradaxa was approved in 2010 to prevent strokes in patients with a type of heart rhythm irregularity known as atrial fibrillation. The condition causes pooling of the blood in a chamber of the heart. This blood can form into a clot and cause a stroke if it enters the bloodstream and travels to the brain. Pradaxa was the first blood thinner approved for atrial ... Read More