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Weekly News Round Up - November 9, 2011

FDA Approval: Xarelto (rivaroxaban) for Stroke Prevention in Atrial Fibrillation

Xarelto, an oral direct factor Xa inhibitor, approved for stroke prevention in atrial fibrillation Read More...

Another anticoagulant agent has been added to the growing arsenal for stroke prevention. Xarelto (rivaroxaban) received Food and Drug Administration approval this week for stroke prevention in patients with nonvalvular atrial fibrillation. The FDA initially approved Xarelto in July of 2011 for prevention of deep vein thrombosis (DVT) in hip or knee replacement surgery. Xarelto, an oral direct factor Xa inhibitor, joins Pradaxa (dabigatran), an oral direct thrombin inhibitor, as new alternatives to the older oral anticoagulant warfarin. The newer agents do not require individualized therapeutic blood monitoring like warfarin. Xarelto should not be stopped abruptly due to the increased risk of stroke.

Rosiglitazone Products Now Under Restricted Access and Distribution Plan

Rosiglitazone prescribing under restricted access program; Avandia, Avandamet and Avandaryl included Read More...

FDA has notified healthcare providers and patients that access to any rosiglitazone-containing medication now requires enrollment in the Avandia-Rosiglitazone Medicines Access Program. Rosiglitazone is used with diet and exercise to improve glucose control in type 2 diabetics. The restriction came about due to data that suggested an increased risk of cardiovascular events, such as heart attack and stroke, in patients who received rosiglitazone. Avandia (rosiglitazone), Avandamet (rosiglitazone-metformin) and Avandaryl (rosiglitazone and glimepiride) are included in the program. Rosiglitazone or rosiglitazone combination products should only be used in patients who are already being treated with these drugs, or who are not candidates for other anti-diabetic agents, including pioglitazone-containing medications.

Polypharmacy May Lead to Medication Problems, Not Remedies

The average American receives 13 prescriptions per year; seniors are at an even greater risk for dangers Read More...

It may bring relief to be handed a prescription at the doctor’s office; you feel that help is on the way. But experts warn that multiple medications, known as “polypharmacy” can lead to unpredictable interactions and side effects. To safeguard against dangers, it is recommended to keep an eye on possible drug interactions each time a new medication is started and be alert for possible side effects. In addition, read the accompanying drug information closely, go over your current medication list with your physician and pharmacist, and keep in mind that over-the-counter drugs, dietary supplements, and even “natural herbals” can have interactions and side effects, too.

Study: Cystic Fibrosis Drug Targets Faulty Protein To Improve Lung Function

Researchers: investigational drug ivacaftor may add decades to lives of those who have target gene variant Read More...

The average life expectancy of a cystic fibrosis (CF) patient is much too short at 39 years. CF is an inherited disease that results in faulty transport of salt and fluids from the lungs and digestive tract. The result is a thick mucous that may lead to serious infections. Researchers report that ivacaftor has shown promise in roughly five percent of CF patients who carry the abnormal G551D gene. Results were impressive, with improved lung function, weight gain, reduced exacerbations, and consistent results throughout the 48-week study period. Ivacaftor is also being studied in combination with another agent that may prove to be useful for the 90 percent of patients with the most common CF gene variant, D508.

FDA Drug Safety Communication: Trilipix (Fenofibric Acid) Label Change

FDA has issued a label change for Trilipix (fenofibric acid) based on fenofibrate results from the ACCORD lipid trial Read More...

The Trilipix (fenofibric acid) prescription label is undergoing changes as noted by the FDA this week. These changes are based on the ACCORD Lipid trial, where fenofibrate (at an equivalent fenofibric acid dose) was given in combination with simvastatin to patients with type 2 diabetes. The simvastatin-fenofibrate group, when compared to the simvastatin only group, showed no significant difference in the risk of heart attack or stroke. FDA is requiring the manufacturer to further study the effectiveness of Trilipix in patients already on a statin but still at high risk for adverse cardiac outcomes due to high triglycerides or reduced "good" cholesterol, also known as high-density lipoproteins (HDL).