Drugs In The News

New drug approved for C. diff

Wednesday, 31 December 1969

Gabriella Lucarelli, PharmD Candidate, 2012 On May 27, 2011 the FDA announced approval for Dificid (fidaxomicin), a new macrolide antibiotic for the treatment of Clostridium difficile (C. diff) [1] . In a head-to-head, non-inferiority trial with oral vancomycin (125 mg) four times a day for ten days, Dificid was found to be non-inferior to vancomycin.  This study also concluded

Arcapta for COPD

Wednesday, 31 December 1969

Ryan Wargo, PharmD Arcapta (indacaterol) is the first long-acting beta-2 agonist (LABA) approved for once-daily use. FDA approved indacaterol in July 2011 for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).1,2 The medication received approval in Europe in 2009 at doses of 150 and 300mcg and has demonstrated safety and efficacy in

Tylenol Dose Lowering: A Long Time Coming?

Wednesday, 31 December 1969

Gabriella Lucarelli, PharmD Candidate, 2012 In February of 2008, the Acetaminophen Hepatotoxicity Working Group put together a 250 + page document containing valuable recommendations for the FDA to limit the number of cases of acetaminophen toxicity [1].  The document, Recommendations for FDA Interventions to Decrease the Occurrence of Acetaminophen Hepatotoxicity, included an in-depth discussion on multiple ways the

Alan Sawatsky, PharmD Candidate 2012 Dietary supplements present a unique challenge to practitioners.  These loosely- regulated, over-the-counter products are widely advertised towards the general public, yet these products are not held to the same FDA standards as prescription medications in terms of having to provide proof of their safety and efficacy.  Glucocil™ is one such recent dietary

Future wave of chemotherapy?

Wednesday, 31 December 1969

Alan Sawatsky, PharmD Candidate 2012 Xalkori approved with companion test The FDA recently approved Pfizer to market Xalkori (crizotinib), targeted to treat patients with late stage, non-small-cell lung cancer (NSCLC) who express mutations of the anaplastic lymphoma kinase (ALK) gene.[1]  Concurrently, the FDA has also approved a companion diagnostic test to help determine if the patient

Dabigatran and Bleeding

Wednesday, 31 December 1969

Sara Dempsey, PharmD Candidate; Kathryn Samai, PharmD, BCPS Dabigatran and Bleeding After the approval of the new oral anticoagulant, dabigatran, practitioners raised concerns regarding the bleeding risk. The FDA noted a large number of post-marketing reports regarding bleeding among patients treated with dabigatran. Since dabigatran’s FDA approval, clinicians are eager to know whether or not the

Shinelle Pierre, PharmD Candidate, Stephanie Peshek, PharmD Current epidemiological studies show the number of new HIV infections in the US since the mid-1990s has remained approximately 50,000 per year1. As part of the ongoing fight to prevent the spread of HIV, Truvada was approved in 2004 by the U.S. Food and Drug Administration (FDA). It is a combination

Rivaroxaban: Expanded Indication

Wednesday, 31 December 1969

Edward McLean, PharmD Candidate In November 2012, the FDA expanded the approved use of the factor Xa inhibitor, rivaroxaban to include treatment of deep vein thrombosis (DVT), treatment of pulmonary embolisms (PE), and risk reduction of recurrent DVT and PE after acute treatment.1  Prior to this action, rivaroxaban gained FDA approval in 2011 for two

Alexander D. Covey, PharmD Candidate; Marcus Campbell, PharmD, BC-ADM Diabetes is a complex chronic disease that requires constant management from both patients and practitioners . Since its founding in 1940, the American Diabetes Association (ADA) has been a leader in promoting research and compiling clinical data for the treatment of diabetes. In order to keep

Mitchelle Rodriguez, PharmD; PGY1 General Practice Resident, Millcreek Community Hospital, Erie, PA Since its publication in 2004, the primary resource for the management of hypertension has been the Seventh Report of the Joint National Committee (JNC 7) on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.1 This comprehensive document includes not only hypertension treatment guidelines,