Tagged Articles

atrial fibrillation 68 articles

Zika virus linked to heart failure, heart rhythm abnormalities in adults

Fallout from the Zika outbreak continues, most recently causing concern that adults who were infected with the mosquito-borne virus may be at an increased risk of heart failure and a heart rhythm abnormality called  atrial fibrillation, according to a prospective observation from multiple centers involved in treating the outbreak in Venezuela. The study focused on nine people who exhibited new-onset cardiovascular symptoms within two weeks of initial confirmed Zika infection. Six were women and three were men. Eight experienced arrhythmia and six were diagnosed with heart failure. In three cases, the arrhythmias were acute with non-sustained atrial tachycardia in two ... Read More

Merck gives up on experimental osteoporosis drug due to safety concerns

Merck’s experimental osteoporosis drug odanacatib showed that it was effective at preventing bone fractures, but put users at risk of atrial fibrillation and stroke. As a result, Merck said that the risks of the drug outweighed the benefits and thus they were officially giving up on the development of odanacatib. Atrial fibrillation is a quivering or irregular heartbeat that can lead to blood clots, strokes, heart failure, and other heart-related conditions. Two years ago, Merck announced it was delaying a filing with the Food and Drug Administration (FDA) after Phase III results raised cardiovascular safety concerns. The news was a blow ... Read More

FDA approves world’s smallest pacemaker

The Food and Drug Administration (FDA) has approved for marketing what is believed to be the world’s smallest pacemaker. Medtronic’s Micra transcatheter pacing system is about one-tenth the size of a conventional pacemaker and is designed to be implanted via catheter in the right ventricle to deliver pacing to a single chamber of the heart. The Micra device, which is about the size of a daily vitamin, has an estimated year-long battery life and is the only transcatheter pacing system to be approved for 1.5 and 3 tesla full-body magnetic resonance imaging scans (MRI). Unlike other pacemakers, the Micra TPS ... Read More

Did Boehringer Ingelheim withhold safety information about blood thinner Pradaxa?

When Pradaxa (dabigatran) hit the market in 2010 to prevent strokes in patients with atrial fibrillation, it became the first alternative treatment to the long-used warfarin for patients with the condition. What made Pradaxa so attractive compared to warfarin (Coumadin) is that patients taking Pradaxa did not have to have their blood monitored on a regular basis in order to prevent potentially deadly bleeding events. However, a British Medical Journal investigation has found that Boehringer Ingelheim, maker of Pradaxa, withheld information that showed patients taking Pradaxa who underwent routine drug level monitoring and dose adjustment could cut bleeding risk by ... Read More

Boehringer Ingelheim to pay $650 million to resolve Pradaxa lawsuits

Boehringer Ingelheim announced it will pay $650 million to resolve about 4,000 state and federal lawsuits alleging the company’s blood thinner Pradaxa caused patients to suffer serious bleeding events. Boehringer Ingelheim denied any wrongdoing and said the settlement is being offered to avoid lengthy litigation. The drug company said it expects most, if not all, the plaintiffs to accept the terms of the settlement, and it will vigorously defend itself against those who do not. Pradaxa (dabigatran) was the first drug to be approved from a new class of blood thinners. The drug has been plagued with reports of excessive ... Read More

Blood thinner Pradaxa linked to greater risk of major gastrointestinal bleeding events

The blood thinner Pradaxa (dabigatran) can help prevent strokes and death better than the long-used warfarin, however it puts users at greater risk for dangerous gastrointestinal bleeding events, according to a Food and Drug Administration (FDA) Drug Safety Communication. Both Pradaxa and warfarin are used to reduce the risk blood clots that can lead to strokes in patients with a common type of heart rhythm abnormality called non-valvular atrial fibrillation. Warfarin has been used for more than 50 years, but patients require regular monitoring due to the bleeding risks. Pradaxa was approved in 2010 and became the first anticoagulant alternative ... Read More

FDA likely to approve medical device designed to prevent strokes in atrial fibrillation patients

A Food and Drug Administration (FDA) advisory panel specializing on circulatory system devices has voted overwhelmingly to recommend approval to Boston Scientific’s Watchman left atrial appendage closure device designed to prevent strokes in patients who suffer from a common irregular heart rhythm condition known as atrial fibrillation. The panel agreed in three separate 13-1 votes that the device was effective, safe, and that the benefits out weighed the risks. The FDA is not required to follow the advice of its expert panels, however it usually does. And, the agency is expect to approve the device. The big question is whether ... Read More

Boehringer Ingelheim fined for bad faith conduct in Pradaxa lawsuits

Pradaxa

German drug company Boehringer Ingelheim was fined nearly $1 million for failing to preserve and produce critical documents in a multidistrict litigation over its blood thinner Pradaxa when the company knew it was facing numerous product liability lawsuits. Company executives were also ordered to be immediately available for depositions in New York or another convenient location for plaintiffs’ counsel. U.S. District Judge David R. Herndon noted that the court has had to referee disputes in the case related to lost, accidentally destroyed or recently discovered evidence, and found these discovery abuses amounted to bad faith conduct. Discovery documents and communications ... Read More

Oversized warfarin tablets lead to product recall

One lot of the popular blood thinner warfarin is being recalled because 2 mg tablets were oversized, which could indicate the medication contains more of the active ingredient than is listed on the drug’s label. An unintended overdose of warfarin increases the risk for potentially deadly bleeding events such as in the gastrointestinal tract or brain. The bleeding risk is increased if overdosing is repeated continuously on a daily basis, which is how warfarin is often prescribed. The recall affects Zydus Pharmaceuticals’ warfarin 2mg tablets from Lot #MM5767 with the expiration date June 2014. The medication is used to prevent ... Read More

New black box warning added to blood thinner Pradaxa

Pradaxa

Stopping treatment of the blood thinner Pradaxa (dabigatran) increases the risk of stroke, according to a new black box warning placed on the drug’s label. Pradaxa is an anticoagulant that was approved in 2010 for the prevention of strokes in patients with a type of heart rhythm abnormality known as atrial fibrillation. Patients with atrial fibrillation, a common irregular heartbeat, are at risk for pooling of the blood in the chambers of the heart, which can form a clot. If the clot breaks off and travels to the brain it can cause a life-threatening stroke. To prevent the clotting of ... Read More