A Year in Review: Novel Drug Approvals and Important FDA Safety Communications for the Year 2016

Transcription

1 A Year in Review: Novel Drug Approvals and Important FDA Safety Communications for the Year 2016 Steven F. Nerenberg, Pharm.D. Clinical Assistant Professor Emergency Medicine Pharmacist Rutgers, The State University of New Jersey St. Joseph s Regional Medical Center

2 Disclosures I have no actual or potential conflict of interest in relation to this program/presentation. 2

3 Learning Objectives Discuss the major FDA safety communications from 2016 and their implications for the practitioner Describe the clinical scenarios in which the risks of using fluoroquinolones outweighs the benefits Summarize the new dosing recommendations for metformin Discuss the novel drug approvals for 2016 and their place in therapy Recognize new drugs in the management of type 2 diabetes mellitus and severe asthma 3

4 fda.gov/drugs/drugsafety 4

5 FLUOROQUINOLONES 5

6 Tendonitis Tendon Rupture Worsening of Myasthenia Gravis Potentially Irreversible Peripheral Neuropathy CNS Effects 6

7 Reserve for patient with no alternative treatments: Uncomplicated urinary tract infection (UTI) Acute bacterial exacerbation of chronic bronchitis (ABECB) Acute bacterial sinusitis (ABS) 7

8 Where did these warnings come from? 178 cases disabling and potentially irreversible AE 2016 Year in Review Muscular system, peripheral and central nervous system Aortic aneurysm and dissection Current use of FQs: RR 2.43 (95% CI, ) Past use of FQs: RR 1.48 (95% CI, ) Retinal Detachment Current use of FQs: OR 1.46 (95% CI, ) 8

9 Bacterial Infection Prevalence: 2-10% 9

10 Antibiotics prescribed in 89% Shorten time to cure Do not improve cure rate 10

11 ABX do not help sinus problems ABX cost money ABX have risks 11

12 Who should receive antibiotics? Symptoms > 1 week 2016 Year in Review Get better worse Severe symptoms 12

13 Avoid ABX in patients yo ABX prescription Rate: 71% 13

14 Alternatives to Fluoroquinolones: S. pneumonia, H. influenzae, M. catarrhalis 2016 Year in Review Amoxicillin Amoxicillin/Clavulanate Doxycycline for Penicillin Allergic AVOID MACROLIDES AND TMP/SMX 14

15 Ibuprofen for UTI? 66% in Abx burden of symptoms 69% Ernest Mario Spontaneous School of Pharmacy Resolution 15

16 Alternatives to Fluoroquinolones: 2016 Year in Review E. coli, S. saprophyticus, K. pneumoniae, Proteus spp TMP/SMX if < 20% resistance Nitrofurantoin Fosfomycin Beta-lactams as 2 nd line 16

17 If you are to use Fluoroquinolones Counsel for symptoms Discontinue immediately if symptoms development 17

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19 METFORMIN 2016 Year in Review 19

20 Metformin Warnings Lactic Acidosis Contraindicated SCr 1.5 mg/dl males, 1.4 mg/dl females 20

21 New Recommendations Obtain egfr Contraindicated in pts w/ egfr < 30 ml/min/1.73 m 2 d/c in pts who drop < 30 ml/min/1.73 m 2 Starting metformin in pts w/ egfr is not recommended If on metformin and egfr drops < 45 ml/min/1.73 m 2, assess risk/ benefits Obtain egfr annually, more in pts with risk (i.e. elderly) 21

22 Saxagliptin and Alogliptin 2016 Year in Review 22

23 Potential Increased Risk of Heart Failure SAVOR Trial (Saxagliptin) 3.5% vs 2.8% in admission w/ HF 2016 Year in Review EXAMINE Trial (Alogliptin) 3.9% vs 3.3% in admissions w/ HF Risk factors: History of HF Renal impairment Does not appear to be with sitagliptin 23

24 Recommendations for the MD Consider risks vs benefits Counsel on S&S of HF Observe for S&S of HF 24

25 SGLT2 Inhibitors 2016 Year in Review 25

26 Pioglitaozne 2016 Year in Review 26

27 OPIOIDS 27

28 References FDA Drug Safety Communication: FDA updates warning for oral and injectable fluoroquinolone antibiotics due to disabling side effects. US Food & Drug Administration website Lee CC, Lee MT, Chen YS, et al. Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. JAMA Intern Med. 2015;175(11): Alternatives to Fluoroquinolones. Med Lett Drugs Ther. 2016;58(1496):75-6. Sharp AL, Klau MH, Keschner D, et al. Low-value care for acute sinusitis encounters: who s choosing wisely? Am J Manag Care. 2015;21(7): Fairlie T, Shapiro DJ, Hersh AL, Hicks LA. National trends in visit rated and antibiotic prescribing for adults with acute sinusitis. Arch Intern Med. 2012;172(19): Lemiengre MS, van Driel ML, Merenstein D, Young J, De Sutter AI. Antibiotics for clinically diagnosed acute rhinosinusitis in adults. Cochrane Database Syst Rev. 2010;10:CD National Committee for Quality Assurance. Avoidance of antibiotic treatment in adults with acute bronchitis: percentage of adults 18 to 64 years of age with a diagnosis of acute bronchitis who were not dispensed an antibiotic prescription. Agency for Healthcare Research and Quality Web site. Available at: Smith SM, Fahey T, Smucny J, Becker LA. Antibiotics for acute bronchitis. Cochrane Database Syst Rev. 2014; (3):CD Barnett ML, Linder JA. Antibiotic prescribing for adults with acute bronchitis in the United States, JAMA. 2014;311(19): Gagyor I, Bleidorn J, Kochen MM, Schmiemann G, Wegscheider K, Hummers-Pradier E. Ibuprofen vs fosfomycin for uncomplicated urinary tract infection in women: randomized controlled trial. BMJ ;351:h6544. FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function. US Food & Drug Administration website ucm htm. Ekstrom N, Schioler L, Svensson AM, et al. Effectiveness and safety of metformin in patients with type 2 diabetes and different levels of renal function: a cohort study from the Swedish National Diabetes Register. BMJ Open. 2012;2(4). 28

29 References Kamber N, Davis WA, Bruce DG, Davis TM. Metformin and lactic acidosis in an Australian community setting: the Fremantle Diabetes Study. Med J Aust. 2008;188(8): Izucchi SE, Lipska KJ, Mayo H, Bailey CJ, McGuire DK. Metformin in patients with type 2 diabetes and kidney disease: a systematic review. JAMA. 2014;312(24): FDA Drug Safety Communication: FDA adds warning about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin. US Food & Drug Administration website ucm htm FDA Drug Safety Communication: Updated FDA review concludes that the use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. US Food & Drug Administration website DrugSafety/ucm htm FDA Drug Safety Communication: FDA strengthens kidney warning for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). US Food & Drug Administration website DrugSafety/ucm htm 29