A year in review: new drugs for older adults in 2011.

BACKGROUND: New drugs approved by the Food and Drug Administration (FDA) may offer tremendous clinical advances by providing health care providers with new treatment strategies. However, additional care must be taken for safe and effective use of these new agents by older adults.
OBJECTIVE: Our objective was to identify FDA-approved medications in 2011 most likely to be prescribed to older adults, and to describe medication characteristics that may require special attention in this population.
METHODS: The FDA Web site was reviewed for new drug approvals from January through December 2011. Approved labeling for each drug was obtained from the manufacturer's Web site and PubMed was searched for primary literature published between 1967 and 2012.
RESULTS: Rivaroxaban, an oral factor Xa inhibitor, is approved for once-daily use in treatment of nonvalvular atrial fibrillation and deep vein thrombosis prophylaxis after replacement of a hip or knee. Drug interactions and renal function must be considered when prescribing this drug to older adults. Fidaxomicin is an oral anti-infective approved for the treatment of Clostridium difficile-associated diarrhea. It has minimal oral absorption or side effects, no relevant drug interactions, but a very high cost. It is a treatment option after failure of oral metronidazole and oral vancomycin. Roflumilast is a selective inhibitor of phosphodiesterase 4 and is approved to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD and a history of exacerbations. It is recommended as a second or alternative choice combined with a long-acting bronchodilator in patients at high risk for hospitalization. Indacaterol is an inhaled long-acting β-agonist approved for COPD maintenance. It is administered once daily, which may improve adherence in older adults compared with currently available twice-daily agents.
CONCLUSIONS: Four new drugs approved in 2011 applicable to the geriatric population are presented. Clinicians must consider the available evidence, cost, drug-drug interactions, renal function, pharmacokinetic/pharmacodynamic differences, and patient preferences when considering prescribing these agents to older adults.