Semaglutide Approved For Cardiovascular Indications

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 …

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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 …

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Avoid CLIA-Waived Testing Violations in Urgent Care

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 …

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UCA Advocates for Urgent Care in Comments on FDA CLIA Draft Guidance

UCA Advocates for Urgent Care in Comments on FDA CLIA Draft Guidance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

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FDA Recommends Scaling Down X-rays for Children

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. …

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FDA Orders Label Changes for Opioid Cough and Cold Medications

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 …

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

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 …

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

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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FDA Appeals Directly to Physicians on Curbing Access to Opioids

FDA Appeals Directly to Physicians on Curbing Access to Opioids

The FDA may have limited authority to reduce the number of opioid medications in circulation at any given time, but its commissioner, Scott Gottlieb, MD, is appealing to urgent care physicians, and prescribers everywhere, to take action. For starters, he said, the agency would like to construct “expert guidelines” informed by the medical community, with the idea that those guidelines could ultimately be reflected in drug labeling (over with the FDA does have authority). Speaking …

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FDA’s Gottlieb Wants More Rigorous Standards for Prescribing Opiates

FDA’s Gottlieb Wants More Rigorous Standards for Prescribing Opiates

Food and Drug Administration Commissioner Scott Gottlieb, MD says his agency needs to do more to help stem the opioid-addiction epidemic in the United Sates. For starters, he wants the FDA to impose stricter guidelines for prescribing immediate-release opioid drugs. The first step will be for the agency to expand training for physicians, nurses, and other providers who administer immediate-release opioids. While there is already training available, the FDA says it will now broaden information …

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