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

Posted 7 days ago 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 14 days ago 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

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

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

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

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

Irregular Heartbeat Poses Greater Stroke Risk for Women Than Men

Posted 8 May 2012 by Drugs.com

TUESDAY, May 8 – Older women with the irregular heartbeat known as atrial fibrillation face a 14 percent greater risk of stroke than men with the same condition, Canadian researchers report. The raised risk remained higher even when women were taking the blood-thinner warfarin (Coumadin) to prevent stroke, the study authors noted. "Previously, there was a common belief that women were undertreated, and this was the cause for the higher risk of stroke," said lead researcher Dr. Louise Pilote, director of the division of general internal medicine at McGill University and McGill University Health Center in Montreal. "Our current paper shows that this is not the situation and, compared to men, women have higher risk for stroke regardless of warfarin prescriptions," she said. "This study should alert doctors treating patients with atrial fibrillation that women, especially older women, have ... Read more

Aspirin as Effective as Warfarin for Heart Failure: Study

Posted 2 May 2012 by Drugs.com

WEDNESDAY, May 2 – Aspirin is just as effective as the blood-thinner warfarin in preventing stroke and death in heart failure patients with a normal heart rhythm, a landmark study indicates. Although the two treatments are equally effective, researchers from Columbia University in New York City said their findings could prompt more doctors and patients to choose aspirin because it is much cheaper. The 10-year study was the largest comparison of aspirin and warfarin (Coumadin) in the treatment of heart failure patients. In conducting the comparison, researchers followed more than 2,300 patients in 11 countries on three continents. Study participants were assigned randomly either to aspirin or warfarin, and neither the patient nor their doctor knew which medication each patient was taking. The investigators found that the combined risk of death, stroke and cerebral hemorrhage during the ... Read more

Stopping Blood Thinners Raises Stroke Risk for Patients With Irregular Heartbeat

Posted 25 Apr 2012 by Drugs.com

WEDNESDAY, April 25 – When patients with atrial fibrillation stop taking anti-clotting drugs, their stroke risk goes up quickly, new research finds. That risk increases about the same whether they are taking warfarin or a newer, more expensive drug, Xarelto (rivaroxaban). Atrial fibrillation is an abnormal heart rhythm in which the upper chambers of the heart quiver or flutter instead of contracting correctly, raising the risk of stroke fivefold. Patients are often put on anti-clotting drugs to ward off stroke. But some people need to temporarily stop taking anti-clotting drugs before surgery or other medical procedures to prevent excess bleeding, while other patients permanently stop taking anti-clotting drugs because of side effects, researchers said. Researchers analyzed data from a previous trial including more than 14,000 patients with atrial fibrillation. In that trial, ... Read more

Warfarin Helps Cut Stroke Risk, Researchers Report

Posted 27 Mar 2012 by Drugs.com

TUESDAY, March 27 – The anti-clotting drug warfarin reduces stroke risk in patients with a heart rhythm disorder called atrial fibrillation, research shows. In atrial fibrillation – the most common type of irregular heartbeat – the heart's upper chambers don't pump blood properly, allowing clots to form that can cause a stroke. Cleveland Clinic researchers led by Dr. Shikhar Agarwal examined data from more than 32,000 people who took part in eight studies that compared warfarin (Coumadin) with newer anti-clotting medications. The investigators found that stroke risk was higher among women, the elderly, patients who had a previous stroke or mini-stroke (also known as a transient ischemic attack) and patients who had never taken anti-clotting drugs called vitamin K antagonists. The study was released online March 26 in advance of publication in an upcoming print issue of the Archives ... Read more

Aspirin, Warfarin Fare Equally for Heart Failure Patients

Posted 3 Feb 2012 by Drugs.com

FRIDAY, Feb. 3 – A major head-to-head trial finds that aspirin is equally as good as warfarin in preventing stroke and death in heart failure patients. The researchers said that, all things being equal, the findings raise questions about the wisdom of routinely using warfarin (Coumadin), which can cause dangerous bleeding. The findings were presented Friday at the annual meeting of the American Stroke Association in New Orleans. Heart failure patients are at increased risk for blood clots, stroke and death. The study is the largest and longest of its kind to date and included more than 2,300 patients averaging 61 years of age. All patients had heart failure and a normal heart rhythm, and were followed for up to six years (average 3.5 years). The patients were randomly assigned to receive either 325 milligrams a day of aspirin or warfarin doses meant to achieve a pre-specified degree of ... Read more

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