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Weekly Drug News Round Up - November 7, 2012

Pfizer’s Xeljanz Approved for Difficult-to-Treat Rheumatoid Arthritis

Xeljanz to be used in patients who have a poor response to methotrexate Read More...

The U.S. Food and Drug Administration (FDA) has approved Xeljanz (tofacitinib), a twice a day pill, to treat adults with moderately to severely active rheumatoid arthritis. Xeljanz is targeted to patients who have had unsuccessful treatment or intolerable side effects with methotrexate. Xeljanz is a janus kinase inhibitor that blocks an enzyme responsible for inflammation and pain of rheumatoid arthritis. Serious side effects, which resulted in a Boxed Warning for the Xeljanz label, include serious infections, tuberculosis, cancers and lymphoma. The most common side effects in studies were upper respiratory tract infections, headache, diarrhea, and nasal passage and upper pharynx inflammation.

Xarelto Approved for Deep Vein Thrombosis and Pulmonary Embolism

New indications add to current approvals for prevention of potentially fatal blood clots Read More...

Xarelto (rivaroxaban) is an oral pill in the class of drugs called factor Xa inhibitors that reduces the ability of the blood to clot. The U.S. Food and Drug Administration (FDA) has approved Xarelto for treatment of deep vein thrombosis (DVT) or pulmonary embolism. DVT occurs when a blood clot forms in a deep vein in the body - if it travels to an artery in the lung, it can result in a potentially fatal lung embolism. Xarelto was previously approved for prevention of blood clots after knee or hip replacements and to reduce the risk of stroke in nonvalvular atrial fibrillation, an abnormal heart rhythm.

FDA Update: Pradaxa Carries No Greater Bleeding Risk

Results are consistent with observations from the large clinical trial used to initially approve Pradaxa Read More...

In December of 2011, the U.S. Food and Drug Administration (FDA) announced concern over post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of abnormal heart rhythm. The FDA has completed a review of adverse events associated with Pradaxa and has found bleeding rates are not greater with the use of Pradaxa than with the initial use of warfarin (Coumadin).

Common Blood Thinner Dosing May Need to Be Revisited

Millions of Americans with coronary artery disease take these drugs to prevent heart attack or stroke Read More...

A new study has found that roughly 75 percent of patients taking two common blood thinners, clopidogrel (Plavix) and prasugrel (Effient) are getting the incorrect dose and could be at risk for potentially fatal blood clots or uncontrolled bleeding. Only 25 percent of patients were receiving the correct dose for either drug. Patients were receiving either too high or too low a dose, putting them at risk for bleeding or clot formation, respectively. A simple blood clotting test may help to individualize doses. Guidelines recommend that patients take the same standardized dose of these drugs, but that dose is not effective for all patients, according to researchers.

Metformin Shown to Prevent Hospitalization, Death

Researchers state metformin should be the first drug considered for treatment in type 2 diabetes Read More...

Patients who received metformin (Glucophage, Fortamet) compared to a sulfonylurea drug for type 2 diabetes demonstrated better outcomes, including a lower risk of hospitalization due to heart attack, stroke or death. The study, published in the Annals of Internal Medicine, states the risk of hospitalization was lowered a modest but significant 21 percent. A statistical analysis revealed that for every 1,000 patients who took metformin for one year there were two fewer heart attacks, strokes or deaths relative to those taking sulfonylureas. Researchers state that metformin should be considered as the first medication choice for patients diagnosed with type 2 diabetes.