Journal of Urgent Care Medicine

FDA Keeping Tabs on Montelukast Suicide Risk

The Food and Drug Administration (FDA) presented the preliminary results of new research on montelukast at the American College of Toxicology meeting recently, describing potential side-effect risks for the oral asthma drug. Montelukast may be leading to mental health conditions and suicide by attaching to multiple brain receptors that are involved in psychiatric functioning, researchers say. According to Reuters, thousands of patients have reported neuropsychiatric episodes, prompting the FDA to launch a comprehensive investigation and …

FDA Allows IV Fluid Imports to Quell Supply Shortage

The Food and Drug Administration has authorized temporary importation of 23 different IV and peritoneal dialysis fluids from 5 Baxter production facilities around the world to address the shortage of these products in the United States in the aftermath of Hurricane Helene, which severely damaged a key Baxter plant in North Carolina 3 weeks ago. The company says the plant will restart production within weeks, and the projected 18,000 tons of imported product deliveries should …

Semaglutide Approved For Cardiovascular Indications

The FDA approved semaglutide to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and obesity or overweight, according to an agency announcement about the new indication. A phase III study of patients with overweight and obesity showed that semaglutide significantly reduced the composite of cardiovascular death, heart attack, and stroke by 20%. In the 3-year study, these major adverse cardiac events occurred in 6.5% of patients on semaglutide …

Abstracts in Urgent Care – March 2018

Confirmed Flu Ups Short-Term Risk for MI Key point: Patients with laboratory-confirmed influenza are almost six times more likely to be admitted for acute myocardial infarction (MI) in the following 7 days. Citation: Kwong JC, Schwartz KL, Campitelli MA, et al. Acute myocardial infarction after laboratory-confirmed influenza infection. N Engl J Med. 2018;378(4):345-353. Results of a cohort study published in the New England Journal of Medicine revealed that patients with laboratory-confirmed influenza were almost six …

Avoid CLIA-Waived Testing Violations in Urgent Care

Urgent message: Most of the laboratory testing that occurs in urgent care consists of simple, on-site tests that are “waived” from federal CLIA regulations—but urgent care centers must still comply with standards affecting their CLIA waiver. All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA requires laboratories to …

UCA Advocates for Urgent Care in Comments on FDA CLIA Draft Guidance

The Urgent Care Association is one of numerous organizations that have filed comments regarding a draft Food and Drug Administration Guidance on CLIA-waived tests. UCA, and others, charge that the spirit of Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices runs counter to the intent expressed by Congress in passing the amendment. For one thing, they maintain, the FDA must remove proposed discussion …

FDA Recommends Scaling Down X-rays for Children

The Food and Drug Administration has issued a new guidance suggesting there should be something of a kids’ menu for imaging, one that employs the lowest dose of radiation possible when imaging younger patients (or avoids x-rays altogether, if feasible). “Pediatric patients generally require less radiation than adults to obtain a quality image from an x-ray exam, so doctors must take extra care to ‘child size’ the radiation dose,” the FDA said in a statement. …

FDA Orders Label Changes for Opioid Cough and Cold Medications

The U.S. Food and Drug Administration will order changes to labeling information for opioid cough and cold medications to limit their use to adults aged 18 years and older. It will also require that new safety information be added to highlight the risk for addiction, abuse, overdose, and other dangerous potential side effects for all patients. Codeine-containing products like Tuxarin ER and Tuzistra ER, as well as products that contain hydrocodone (eg, Flowtuss, Rezira) will …

FDA Tools Up to Help Providers Fight Resistance and Get Timelier Antibiotic Updates

The Food and Drug Administration unveiled a new tool designed to give urgent care physicians and other providers more timely access to updates on antibiotics and antifungal drugs this week. The overarching aim is to help clinicians anticipate when bacterial or fungal infections are likely to respond to a specific drug. Under the new approach, FDA can simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information transparently …

Do You Really Know What’s in that IV Bag?

A New York urgent care center, several of its staff members, and a company that manufactures practice devices for medical education are all being sued by a woman who claims she became serious ill by being given a nonsterile solution that was actually intended only for training purposes. The suit alleges that in December 2014 staff administered IV fluids from a practice IV bag made by Wallcur LLC instead of the proper sterile solution that …

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