This computerized bibliographic search assesses the efficacy and safety of the sublingual tablets licensed as drugs in the treatment of patients with seasonal allergic rhinoconjunctivitis to grass pollen.
This systematic review assessed the safety and procedural success of the Lariat device, and the investigators found significant risks of major adverse events with off-label use for left atrial appendage exclusion.
This cohort study identifies a greater cardiovascular risk with use of testosterone injections vs gels.
This randomized clinical trial found that 1 dose of zoledronic acid improved bone mineral density over 2 years in frail elderly women with osteoporosis, but the clinical importance of nonsignificant increases in fracture and mortality needs further study.
This longitudinal study raises questions regarding the safety of combination antihypertensive therapy regimen in frail elderly patients with low systolic blood pressure.
This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits, including improved quality of life, use of fewer nonstatin medications, and a corresponding reduction in medication costs. See the Invited Commentary by Holmes and Todd.
This randomized clinical trial finds that use of the nicotine patch for 24 weeks is safe, although efficacy does not extend beyond that point.
This Viewpoint describes the Food and Drug Administration’s unique device identification system for medical devices and recommends that federal agencies, specialty societies, and health care organizations collaborate to ensure that the system’s potential is fulfilled.
This study reports a lack of publicly available scientific evidence of substantial equivalence for medical devices and their predicates cleared by the FDA through the 501(k) process between 2008 and 2012.
This descriptive study discusses how the lack of information on the effect of Postapproval studies ordered in recent years limit their ability to answer important questions about the safety and effectiveness of medical devices. See also the Invited Commentary by Sharfstein.
Gaines and colleagues highlight health and safety concerns for people traveling to these events in Brazil so that health care practitioners can better prepare travelers before they travel and more effectively diagnose and treat travelers after they return.
Tseng et al identify high-risk patients in the Veterans Health Administration with diabetes mellitus who had evidence of intensive glycemic management, and thus were at risk for serious hypoglycemia. See also the Editor’s Note by Steinbrook.
To inform the debate about appropriate standards, Moore and Furberg studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US FDA in 2008. Carpenter provides an Invited Commentary.
Smith et al compare the relative clinical cardiovascular safety of 2 commonly used oral estrogen drugs—conjugated equine estrogens and estradiol. Their case-control study compares cardiovascular event risk among 384 postmenopausal women aged 30 to 79 years using oral hormone therapy. Incident venous thrombosis was the primary clinical outcome.
Neltner et al determine the extent to which individuals selected by manufacturers to make “generally recognized as safe” determinations have conflicts of interest between their obligations to ensure that the use of the additive is safe and their financial relationships to the company. Nestle provides an Invited Commentary on the topic.
Schiff and coauthors study patterns of primary care malpractice types, causes, and outcomes as part of a Massachusetts ambulatory malpractice risk and safety improvement project. See Invited Commentary by Hyman and Sage.