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FDA Medwatch Alert: Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter

Posted 19 days ago by Drugs.com

ISSUE:  Bristol-Myers Squibb Company issued a voluntary recall of six lots of Coumadin for Injection, 5 mg single-use vials in the U.S. Visible particulate matter was found in a small number of Coumadin for Injection unreleased samples. Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur. To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to this issue. Coumadin for Injection 5 mg single-use vials is packaged in cartons of six vials. The affected Coumadin for Injection includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014: 201125, 201126, 201127, 201228, 201229, 201230. BACKGROUND: Coumadin for Injection was discontinued in ... Read more

Related support groups: Coumadin, Warfarin, Pulmonary Embolism, Jantoven

Doctors' Groups Issue New Guidelines on Treating Common Irregular Heartbeat

Posted 28 Mar 2014 by Drugs.com

FRIDAY, March 28, 2014 – Reduced use of aspirin and the addition of three new blood thinners as treatment options are among the recommendations in updated guidelines to manage a heart rhythm disorder called atrial fibrillation, which is a major risk factor for stroke. According to the American Heart Association, atrial fibrillation involves rapid and disorganized electrical signals that cause the heart's two upper chambers – the atria – to contract rapidly and irregularly. Symptoms can include rapid and irregular heartbeat, heart palpitations, shortness of breath, dizziness, sweating, fatigue or chest pain. Atrial fibrillation is not a fatal condition, but it can increase a person's risk of stroke five-fold. That's because atrial fibrillation allows blood to pool in the atria and form clots, the AHA said. One study published in November at the AHA's annual meeting found that ... Read more

Related support groups: Aspirin, Coumadin, Warfarin, Atrial Fibrillation, Xarelto, Pradaxa, Prevention of Thromboembolism in Atrial Fibrillation, Ecotrin, Eliquis, Rivaroxaban, Bayer Aspirin, Bufferin, Jantoven, Dabigatran, Low Dose ASA, Aspergum, Easprin, ZORprin, Buffered Aspirin, Ascriptin Enteric

Warfarin Safe for Kidney Patients With Irregular Heartbeat: Study

Posted 4 Mar 2014 by Drugs.com

TUESDAY, March 4, 2014 – People with chronic kidney disease who take the blood thinner warfarin to treat a form of irregular heartbeat are at no greater risk for stroke or death than similar patients who don't take the medicine, researchers report. The Swedish study involved more than 24,000 people diagnosed with heart disease and atrial fibrillation, a common and dangerous form of irregular heartbeat. In atrial fibrillation, blood pools in the heart's chambers, raising the risk for stroke. Researchers led by Juan Jesus Carrero of the Karolinska Institute in Stockholm examined the link between treating atrial fibrillation with a blood thinner and patients' kidney function. The study, published in the March 5 issue of the Journal of the American Medical Association, found that taking warfarin was associated with a lower one-year risk of death, heart attack or stroke combined, without ... Read more

Related support groups: Coumadin, Warfarin, Prevention of Thromboembolism in Atrial Fibrillation, Jantoven

Warfarin May Up Stroke Risk in Those With Irregular Heartbeat: Study

Posted 19 Dec 2013 by Drugs.com

WEDNESDAY, Dec. 18, 2013 – Many older Americans take the blood thinner warfarin to help guard against heart trouble. However, a new study suggests use of the drug is tied to a temporary spike in the risk of stroke for people with a common heart rhythm disorder. People with the irregular heart beat known as atrial fibrillation had nearly double the odds of suffering a stroke in the month after they started taking warfarin, compared to similar patients who weren't taking the medication, researchers report. The findings seem counterintuitive, since many people with atrial fibrillation are placed on warfarin to help lessen their odds for a stroke, the researchers noted. However, prior studies have suggested that there may be an initial period of heightened risk after people move from other drugs to warfarin. Patients who are new to warfarin might also experience a temporary state of ... Read more

Related support groups: Coumadin, Warfarin, Prevention of Thromboembolism in Atrial Fibrillation, Jantoven

Studies Suggest Better Approaches to Staying Clot-Free

Posted 19 Nov 2013 by Drugs.com

TUESDAY, Nov. 19, 2013 – Genetic testing could help better guide doctors' use of warfarin, new research suggests. The blood-thinning medication is widely used to prevent stroke and heart attack in people with irregular heartbeats. Warfarin is a popular medication, but a tricky one to use, the researchers said. Patients who receive too strong a dose can suffer from unusual and excessive bleeding, potentially coughing up or vomiting blood, according to the American Heart Association (AHA). But doctors who used genetic testing to guide patients' warfarin doses were better able to quickly reach and consistently remain within the drug's therapeutic "sweet spot," according to the study. It was published in the Nov. 19 online edition of the New England Journal of Medicine and presented Tuesday at the AHA's annual meeting in Dallas. "[Blood-thinning] therapy is difficult and it's associated ... Read more

Related support groups: Coumadin, Warfarin, Prevention of Thromboembolism in Atrial Fibrillation, Jantoven

FDA Medwatch Alert: Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets

Posted 12 Jun 2013 by Drugs.com

ISSUE: Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint. Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ (mostly the central nervous system) could be fatal. The risk of bleeding is increased if overdosing is repeated continuously on a daily basis. BACKGROUND:  The product is used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) ... Read more

Related support groups: Coumadin, Warfarin, Jantoven

Blacks With Certain Gene Need Lower Doses of Warfarin: Study

Posted 5 Jun 2013 by Drugs.com

WEDNESDAY, June 5 – The discovery of a genetic variation that affects how some black patients respond to the blood thinner warfarin could improve the safety and effectiveness of the drug, researchers report. Blacks with this common genetic variation need a significantly lower dose of warfarin than those without the variation, the researchers report online June 4 in The Lancet. "Adding this genetic marker – found in more than 40 percent of African-American patients in the study – to standard dosing algorithms improved the predictability of warfarin dosing by 21 percent in these individuals, which has the potential to increase the safety and effectiveness of this notoriously hard-to- dose drug," study leader Julie Johnson, of the University of Florida, said in a journal news release. Warfarin is widely used to prevent blood clots in patients with a heart rhythm disorder called atrial ... Read more

Related support groups: Coumadin, Warfarin, Jantoven

New Blood Thinner Beats Older Drug for Vein Clots: Study

Posted 20 Feb 2013 by Drugs.com

WEDNESDAY, Feb. 20 – People who need to take a blood thinner because they've had a clot in the deep veins of their legs appear to do better with the new drug Pradaxa (dabigatran) than with the older drug warfarin, researchers report. Long-term treatment of these blood clots is safer and more convenient with Pradaxa than warfarin, the new study found. Extended treatment with blood thinners after clots develop in the veins or the lungs should be considered more often than it is, said lead researcher Dr. Sam Schulman, a professor in the division of hematology and thromboembolism at McMaster University in Hamilton, Ontario, Canada. If a clot in the leg breaks loose and travels to the heart, brain or lungs, it can cause a heart attack, stroke or a pulmonary embolism – all of which can be fatal. People taking warfarin need periodic blood tests to be sure they aren't getting too much of the ... Read more

Related support groups: Coumadin, Warfarin, Pradaxa, Deep Vein Thrombosis (DVT), Deep Vein Thrombosis, Dabigatran, Jantoven

Common Antidepressants Tied to Higher Bleeding Risk in Warfarin Users: Study

Posted 8 Nov 2012 by Drugs.com

THURSDAY, Nov. 8 – Millions of older Americans take the blood thinner warfarin, and many may also take one of a widely used class of antidepressants called SSRIs. Now, a new study finds that selective serotonin reuptake inhibitors (SSRIs) – which include Celexa, Paxil, Prozac and Zoloft – may raise the risk for major bleeding in patients also taking warfarin. Still, because depression is such a tough-to-treat illness, experts say the finding is no reason for patients on warfarin to immediately drop their SSRI. "The most important thing would be to talk to their doctor, and perhaps for patients who are on both of these medicines, doctors should just keep a close eye on them," said study author Gene Quinn, who was a resident physician in internal medicine at the University of California, San Francisco, at the time of the study. He presented the finding this week at the American Heart ... Read more

Related support groups: Depression, Lexapro, Zoloft, Prozac, Celexa, Paxil, Citalopram, Coumadin, Warfarin, Sertraline, Fluoxetine, Escitalopram, Paroxetine, Luvox, Paxil CR, Fluvoxamine, Sarafem, Luvox CR, Pexeva, Jantoven

New Anti-Clotting Drug Bests Warfarin, Study Says

Posted 1 Oct 2012 by Drugs.com

MONDAY, Oct. 1 – A new anti-clotting drug called apixaban was better than warfarin at preventing stroke in patients with the heart rhythm disorder atrial fibrillation, a new study found. Data from more than 18,000 patients also found that apixaban was safer overall than warfarin, and tended to cause less bleeding in the skull in patients who faced the highest risk of bleeding. The findings suggest that the current risk scoring systems for tailoring anti-clotting (anticoagulant) treatment to individual patients may be less relevant when using apixaban for patients with atrial fibrillation who have at least one risk factor for stroke, according to the Duke University Medical Center researchers. "The benefits of apixaban are preserved, regardless of the risk score used and regardless of the patient risk category," study author and cardiologist Dr. Renato Lopes said in a Duke news release. ... Read more

Related support groups: Coumadin, Warfarin, Prevention of Thromboembolism in Atrial Fibrillation, Jantoven

Study Assesses Blood Thinner Use After Gastrointestinal Bleeding

Posted 17 Sep 2012 by Drugs.com

MONDAY, Sept. 17 – New research suggests that people who stop taking the blood thinner warfarin (Coumadin) because of gastrointestinal bleeding raise their risk of blood clots and death if they stay off the drug. The study, published online Sept. 17 in the Archives of Internal Medicine, is limited because it looks only at what happened to patients over a 90-day period after suffering from gastrointestinal bleeding. But the findings do point to the risk of staying off the blood thinner for a long period, said Dr. Amir Jaffer, professor of medicine and division chief for hospital medicine at the University of Miami and co-author of a commentary accompanying the study. In general, Jaffer said, he recommends that patients who suffer from bleeding in the gastrointestinal tract stop taking the blood thinner for about four days unless a significant reason exists to avoid the drug for the long ... Read more

Related support groups: Coumadin, Warfarin, Jantoven

Irregular Heartbeat May Pose Higher Stroke Risk for Women Than Men

Posted 31 Aug 2012 by Drugs.com

FRIDAY, Aug. 31 – Women older than 75 who have a heart rhythm disorder called atrial fibrillation are 20 percent more likely to have a stroke than men in the same age group with atrial fibrillation, according to a large new study. However, researchers said the findings suggest that being a woman should not be included as an independent risk factor for stroke or blood clots, either in guidelines for treatment or risk assessment of patients with atrial fibrillation, because the difference doesn't hold for women younger than 75. The study included more than 87,000 atrial fibrillation patients in Denmark. Of those patients, more than 51 percent were female. After one year of follow-up, female patients younger than 75 did not have an increased risk of stroke, but those over age 75 had a 20 percent increased risk, the investigators found. The study was presented Sunday at the European ... Read more

Related support groups: Coumadin, Warfarin, Atrial Fibrillation, Xarelto, Pradaxa, Lovenox, Heparin, Prevention of Thromboembolism in Atrial Fibrillation, Enoxaparin, Clexane, Rivaroxaban, Fragmin, Arixtra, Hep-Pak, Fondaparinux, Dalteparin, Jantoven, Dabigatran, Normiflo, Tinzaparin

Clot-Busting Stroke Drug Safe for Many Who Take Warfarin

Posted 26 Jun 2012 by Drugs.com

TUESDAY, June 26 – Many patients who've been taking the blood thinner warfarin can safely be administered the powerful clot-busting drug tPA in the event of a stroke, a new study shows. The findings help ease previous concerns that tPA (tissue plasminogen activator) might be too dangerous to use in stroke patients who had been taking warfarin because it would increase their risk for potentially fatal bleeding in the brain. Researchers at Duke University's Clinical Research Institute in Durham, N.C., analyzed data from thousands of stroke patients treated with intravenous tPA at more than 1,200 hospitals. While patients who were taking warfarin did have slightly higher rates of intracranial bleeding than those who were not taking warfarin (5.7 vs. 4.6 percent), they also tended to be older, the researchers noted. So, after the researchers adjusted for age, stroke severity and other ... Read more

Related support groups: Coumadin, Warfarin, Ischemic Stroke, Jantoven

Quick-Reversal Method May Be at Hand for New Blood Thinner

Posted 20 Jun 2012 by Drugs.com

WEDNESDAY, June 20 – Newer blood-thinning drugs sometimes have one drawback: In cases where they trigger bleeding, their effects can be tough to reverse compared to the standard anticoagulant, warfarin. Now, a new study finds there are three different approaches to reverse the action of one new blood thinner, apixaban (Eliquis) – a drug that's currently under review by the U.S. Federal Drug Administration. Researchers in Spain noted that it remains unclear which method for reversing this new drug might be best. "If you have an accident or need emergency surgery, doctors have three ways to reverse [the older, standby blood-thinner] warfarin that work in a matter of minutes to hours. In contrast, there is little information on how best to reverse the effects of newer anticoagulants, which can take 10 to 18 hours," study author Dr. Gines Escolar, an associate professor of hematology at ... Read more

Related support groups: Coumadin, Warfarin, Xarelto, Rivaroxaban, Jantoven

Clot-Buster Doesn't Raise Bleeding Risk in Warfarin Patients: Study

Posted 10 May 2012 by Drugs.com

THURSDAY, May 10 – Tissue plasminogen activator (tPA), a drug used to combat clots in stroke patients, does not increase the risk of dangerous bleeding in patients also taking the blood thinner warfarin, new research found. The study included information on more than 23,000 ischemic stroke patients treated with tPA at more than 1,200 U.S. hospitals. Ischemic stroke, the most common type of brain attack, is caused by a blocked blood vessel to the brain. The clot-busting drug tPA is sold under the brand name Activase and the generic name alteplase. In the study, about 8 percent of the stroke patients were taking the anticoagulant warfarin (Coumadin) before hospital admission. The researchers found little difference in the risk of severe bleeding due to a brain hemorrhage in patients who received tPA while on warfarin versus those not taking the blood-thinning drug. The study also found ... Read more

Related support groups: Coumadin, Warfarin, Ischemic Stroke, Ischemic Stroke - Prophylaxis, Jantoven

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