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anticoagulant 48 articles

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 panel gives thumbs-down to new anti-platelet drug cangrelor

The new intravenous blood thinner cangrelor should not be approved for marketing because data from two separate clinical trials demonstrating the drug’s safety and efficacy were unconvincing and flawed, a Food and Drug Administration (FDA) advisory panel found. Cangrelor was being considered for two separate indications – to prevent blood clots associated with coronary stenting and in patients whose existing antiplatelet therapy is interrupted for surgery. Cangrelor is a member of the P2Y12 inhibitor class of antiplatelet agents, which also includes clopidogrel (Plavix), prasugrel (Effient), and ticagrelor (Brilinta). Committee member Stuart Rich, M.D., of the University of Chicago, expressed concerns ... Read More

Personal injury lawsuits piling up against makers of blood thinner Plavix

Personal and financial injury lawsuits involving the blood thinner Plavix are piling up in New Jersey against the drug’s makers, with 73 currently in the multidistrict litigation with at least another 14 being considered for transfer. The lawsuits allege the drug companies falsely advertised the prescription anti-clotting medication as a gentler-than-aspirin treatment designed to prevent heart attacks and strokes even though they knew the drug increased the risk for heart attacks, strokes, internal bleeding and death. Plavix, also known as clopidogrel, is manufactured and sold by Bristol-Myers Squibb and Sanofi-Aventis, and is aided by McKesson Corporation. The drug was approved ... 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

Consumer watchdog wants strong warnings placed on blood thinner Plavix

Consumer watchdog group Public Citizen is lobbying federal drug regulators to place a black box warning on the anticoagulant Plavix notifying that patients with drug-delivering coronary artery stents could die from a major bleeding event if they take the medication for more than a year. A black box warning is the strongest warning placed on prescription medication and is given to products that, based on medical studies, pose a serious or life threatening risk for adverse events. More than 25 million prescriptions for Plavix, and its generic equivalent clopidogrel, were written during the past year. The blood thinner is used alone ... 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