Bugs, Drugs and In the News: Recently Approved Drugs ANNESHA WHITE, PHARMD, MS, PHD UNIVERSITY OF NORTH TEXAS SYSTEM COLLEGE OF PHARMACY

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1 Bugs, Drugs and In the News: Recently Approved Drugs ANNESHA WHITE, PHARMD, MS, PHD UNIVERSITY OF NORTH TEXAS SYSTEM COLLEGE OF PHARMACY

2 New FDA-Approved Drugs Since January 2015, the FDA has approved over 100 medications, many indicated for primary care diseases A brief look at several of the newest approvals, starting with the most recent is provided

3 New FDA-Approved Drugs Olopatadine hydrochloride (Pazeo) A mast cell stabilizer for treatment of ocular itching associated with allergic conjunctivitis Pazeo solution is dosed 1 drop daily, and was approved with efficacy data at 24 hours, post dose Approved 1/30/15

4 New FDA-Approved Drugs Amlodipine besylate/perindopril arginine (Prestalia) Combines a calcium channel blocker and long-acting ACE inhibitor for treatment of hypertension The first fixed-dose combination of these two medications, this medication may be used in patients whose blood pressure is not adequately controlled with monotherapy May be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals Approved 1/21/15

5 New FDA-Approved Drugs Edoxaban (Savaysa) An oral, once-daily factor Xa inhibitor anticoagulant indicated for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Also indicated for the treatment of deep vein thrombosis and pulmonary embolism Approved: 1/8/15

6 New FDA-Approved Drugs Sildenafil Citrate (Generic Viagra) First generic version of Viagra, for the treatment of erectile dysfunction Tablets in 25 mg, 50 mg, and 100 mg strengths and has 180-day exclusivity Approved: 2/24/16

7 Updates on FDA-Approved Drugs The criteria include over 50 medications designated in one of three categories: those that should always be avoided (eg, barbiturates, chlorpropamide); those that are potentially inappropriate in older adults; and those that should be used with caution New additions since 2012 are a table of non-antiinfective drug interactions and a table of non-anti-infective medications to avoid or adjust for decreased renal function Notable changes - a more liberal renal threshold for withholding nitrofurantoin (now creatinine clearance <30 rather than <60 ml/min) Notable changes - removal of loratadine from the list of medications with strong anticholinergic properties Notable changes - avoidance of long-term proton pump inhibitors because of risk of C. difficile infections and bone loss Notable changes - stricter guidelines to avoid antipsychotics for behavioral problems unless other options have failed and the older adult is threatening harm to self or others

8 Updates on FDA-Approved Drugs High-dose vitamin D may increase risk of falls (February 2016) Evidence conflicts on the effectiveness of vitamin D for fall prevention in older adults Emerging evidence that high-dose vitamin D administered monthly may increase fall risk A RCT compared monthly high-dose vitamin D (60,000 international units of vitamin D 3 in one group; 24,000 international units vitamin D 3 plus 300 microg calcifediol in another) with a lower dose (24,000 units vitamin D 3 ) in community-dwelling men and women age 70 and older who had a history of a prior fall Lower extremity function at 12 months did not differ among the groups, but there was a higher incidence of falls and mean number of falls in both groups that received high-dose vitamin D

9 Updates on FDA-Approved Drugs FDA Warns Some Diabetes Drugs Could Increase Risk Of Heart Failure In Certain Patients The Food and Drug Administration announced new warnings to be added to the labels of diabetes drugs that contain either saxagliptin or alogliptin Either of the compounds can cause heart failure in certain patients Medications included in the warning are Saxagliptin (Onglyza), Saxagliptin and Metformin (Kombiglyze XR), Alogliptin (Nesina), Alogliptin and Metformin (Kazano), and Alogliptin and Pioglitazone (Oseni) The drugs may raise the risk of heart failure, particularly in patients with heart or kidney disease Consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure

10 Updates on FDA-Approved Drugs Revised schedule for pneumococcal vaccination in older adults (September 2015) The 23-valent pneumococcal polysaccharide vaccine (PPSV23) has been recommended for many years in the US for all adults 65 years of age US Advisory Committee on Immunization Practices (ACIP) began also recommending the 13-valent pneumococcal conjugate vaccine (PCV13) for adults 65 years of age September ACIP changed the recommended interval between administration of PCV13 and PPSV23 for immunocompetent adults 65 years of age from 6-12 months to 1 year to simplify the administration schedule In patients who have already received PPSV23, at least 1 year should elapse before they are given PCV13

11 Updates on FDA-Approved Drugs Caution in Prescribing Opioid Pain Medications No longer than the three-day period recommended by the Centers for Disease Control and Prevention Avoid prescribing for unsuitable conditions, such as lower back and dental pain Notice non-addictive medications as alternative treatments which may be more effective

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