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warfarin 75 articles

Warfarin for atrial fibrillation patients linked to dementia

Patients with the common heart rhythm abnormality atrial fibrillation (AF) are routinely prescribed blood thinners, such as the long-used warfarin, to reduce the risk of blood clot-related strokes. However, a new study has linked the use of warfarin to an increased dementia risk. Patients with heart problems tend to be at greater risk of dementia, previous studies have found. But the association grows stronger in patients treated long-term with warfarin, say researchers with the Intermountain Medical Center Heart Institute. For the study, researchers recruited more than 10,000 patients with or without atrial fibrillation and gave them the blood thinners in different ... Read More

FDA issues warning letter to warfarin maker over ‘persistent failures’

The Food and Drug Administration (FDA) issued a warning letter to Cadila Healthcare Ltd., citing “persistent failures” that indicate manufacturing practices at the plant are “not in a state of control.” The warning letter comes after inspections of two Cadila sites in the western India city of Ahmedabad, during which the agency identified numerous violations including failure to properly investigate out-of-specification batches of the blood thinner warfarin. Yet, the drug continues to be released to the market. The issue was first called out by the FDA in 2013, which resulted in Cadila suspending production of the warfarin. However, when production ... Read More

Common blood thinner Coumadin linked to birth defects

The safety label of the long-used blood thinner Coumadin, known generically as warfarin, has been updated to include a warning for use in pregnant women because use can cause harm to developing fetuses and newborns, resulting in birth defects. Coumadin is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves who are at high risk of thromboembolism, or blood clot, for whom it has been determined that the benefits of Coumadin therapy outweigh the risks. Women treated with warfarin in their first trimester of pregnancy have about a five percent risk of their baby being ... 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

Vials of blood thinner Coumadin recalled due to possible contamination

Six lots of the commonly prescribed blood thinner Coumadin (warfarin) are being recalled because visible particulate matter was found in some vials of the drug. If injected, particulate – whether of metallic or non-metallic cellulose matter – can cause serious and potentially fatal adverse reactions including embolization, as well as allergic reactions. Coumadin is a prescription medication used to treat blood clots and to lower the risk of blood clots forming in the body. It is available in both an oral and an injectable formulation. The injectable formulation is typically administered in a hospital setting by health care professionals to ... 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

Researchers receive funding for innovative new blood thinner

Researchers have received financial support to develop a new kind of blood thinner they believe may prevent life threatening blood clots without causing major bleeding events, a dangerous side effect to currently marketed anticoagulants. Index Ventures is teaming up with GlaxoSmithKline and Johnson & Johnson to create X01, a new company formed to develop experimental drugs. The new $11 million venture early-stage biotech fund will help fund research into the innovative blood thinner ichorcumab. The drug is still in the very early stages of development with clinical trials not expected for at least another two years. However, financial analysts say ... 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

FDA approves new reversal agent for blood thinner warfarin

The Food and Drug Administration (FDA) has approved Kcentra (Prothrombin Complex Concentrate, Human) for patients who need an immediate reversal of the anti-clotting effects of the blood thinner warfarin. Until now, plasma was the only product approved in the United States to counter acute major bleeding events in patients using warfarin. Warfarin is in a class of blood thinners known as vitamin K antagonists, or VKA. The drug has been on the market for decades comes in both of brand name and generic versions. One of the most common uses for warfarin is to prevent strokes in patients with a ... Read More

Officials offer theories why Pradaxa associated with so many bleeding events

Pradaxa

Theories abound as to why bleeding risks with the blood thinner Pradaxa (dabigatran) appear greater than the long-used Coumadin (warfarin). In a perspective published online in the New England Journal of Medicine, Food and Drug Administration (FDA) officials speculate the concern may be due to the heightened sensitivity and vigilance that generally accompany new drugs. Pradaxa is a new class of blood thinner that was approved by the FDA in 2010 to prevent strokes in patients with a common but life-threatening type of abnormal heart rhythm known as atrial fibrillation. It became one of the first alternatives to warfarin, and ... Read More