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Weekly Drug News Round Up - January 2, 2013

Sirturo Approved to Treat Multi-Drug Resistant Tuberculosis

Sirturo is the first drug approved to treat multi-drug resistant TB Read More...

Sirturo (bedaquiline) has been approved to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. Close to nine million people globally and 10,528 people in the U.S. contracted TB in 2011. TB is a contagious disease spread via respiratory droplets from person-to-person and affects the lungs. Multi-drug resistant TB occurs when M. tuberculosis becomes resistant to isonazid and rifampin, two drugs most commonly used to treat TB. Sirturo should be used in combination with other drugs used to treat TB. Sirturo contains a Boxed Warning stating the drug can affect QT prolongation and may lead to abnormal heart rhythms.

Fulyzaq: Botanical Anti-Diarrheal Drug Approved for HIV/AIDS Patients

In some patients, an anti-diarrheal effect was seen for 20 weeks Read More...

Watery diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients stop or switch their AIDS medications (antiretroviral therapies). The U.S. Food and Drug Administration (FDA) has approved Fulyzaq (crofelemer) to treat diarrhea in HIV/AIDS patients taking antiretroviral therapy. Fulyzaq is the first anti-diarrheal drug approved for HIV/AIDS patients, but is not to be used for diarrhea due to an infection. In a clinical trial, 374 HIV-positive patients received Fulyzaq or placebo twice a day. Results showed that 17.6 percent of patients taking Fulyzaq experienced two or fewer watery bowel movements weekly compared with 8 percent taking placebo.

Eliquis Approved to Reduce the Risk of Stroke

Safety and effectiveness was demonstrated in a trial with over 18,000 patients Read More...

The U.S. Food and Drug Administration has approved Bristol-Myers Squibb’s anticlotting drug Eliquis (apixaban). Eliquis is a factor Xa inhibitor oral anticoagulant indicated to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation not caused by a heart valve problem. Atrial fibrillation is a common type of abnormal heart rhythm that can result in blood clot formation and subsequent stroke if the clot travels to the brain. Eliquis effectiveness was demonstrated in a clinical trial with warfarin; patients taking Eliquis had fewer strokes than those who took warfarin. Pradaxa (dabigatran) and Xarelto (rivaroxaban) are also approved for similar indications.

Pediatric Drug Shortage Increases Cancer Relapse Rates

Manufacturers need to inform FDA of possible vital drug shortages or discontinuations Read More...

The U.S. Food and Drug Administration (FDA) has made efforts recently to help prevent vital drug shortages, and the need for this effort is obvious. Children with Hodgkin’s Lymphoma receiving cyclophosphamide instead of mechlorethamine due to a national mechlorethamine drug shortage in 2009 were found to have a higher cancer relapse rate. Physicians felt the cyclophosphamide would work just as well in the chemotherapy regimen, but a new analysis in the New England Journal of Medicine shows this was not the case. Statistics reveal the two-year remission rates dropped from 88 to 75 percent after the drug switch.

Naltrexone May Help Women Afraid to Quit Smoking Because of Weight Gain

Eighty percent of people who quit smoking gain weight, averaging roughly five to 15 pounds Read More...

Combining the nicotine patch with counseling and naltrexone (ReVia) - a drug used to treat addiction - may help women who are trying to quit smoking avoid some weight gain. A review of previous studies that compared the quit rates and weight gain among heavy smokers using naltrexone or a placebo, along with the patch and counseling, found women who took naltrexone gained roughly 13 pounds one year after treatment compared to 16.3 pounds in the placebo group. The difference was not seen in men. Naltrexone is not approved by the FDA for smoking cessation but is used off-label for this indication.