‘Tied’ Tagged Posts

Fluoroquinolones Tied to Elevated Threat for Arrhythmia, CV Mortality

Results showed fluoroquinolone use increased the risk for arrhythmia by 85% Fluoroquinolone antibiotics appear to increase the risk for arrhythmia and...

 
Results showed fluoroquinolone use increased the risk for arrhythmia by 85%

Results showed fluoroquinolone use increased the risk for arrhythmia by 85%

Fluoroquinolone antibiotics appear to increase the risk for arrhythmia and cardiovascular mortality, according to a study published in the journal Drug Safety.

To investigate the risk of cardiovascular adverse effects associated with this antibiotic class, researchers conducted a systematic review, meta-analysis, and network meta-analysis using studies identified through a search of MEDLINE, EMBASE, and the Cochrane Library; 13 studies were selected for inclusion. “Outcomes were pooled using random effects models,” the authors explained. “Direct and indirect comparisons in network meta-analysis were performed using frequentist methods.”

Results showed fluoroquinolone use increased the risk for arrhythmia by 85% (odds ratio [OR] 1.85; 95% CI, 1.22–2.81) and cardiovascular mortality by 71% (OR 1.71; 95% CI, 1.39–2.09). Of the fluoroquinolones included in the analysis, moxifloxacin was found have the highest probability for cardiovascular adverse events (arrhythmia [P-score 0.99]; cardiovascular mortality [P-score 0.95]).

“Our findings show a significant association between fluoroquinolone use and an increased risk for arrhythmia and cardiovascular mortality,” the authors concluded. They added, “Further study is required to determine how to reduce the risk for fluoroquinolone-associated cardiac toxicity.”

FDA: Instances of Uncommon Gangrene of Genital Space Tied to Diabetes Drug Class

 
The FDA is requiring a new warning be added to the prescribing information and patient Medication Guide of all SGLT2 inhibitors.

The FDA is requiring a new warning be added to the prescribing information and patient Medication Guide of all SGLT2 inhibitors.

Necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, is a serious infection of the genitals and area around the genitals. Over a 5-year period (March 2013 to May 2018), the FDA identified 12 cases (7 men and 5 women) of Fournier’s gangrene in patients taking an SGLT2 inhibitor. The infection developed within several months of the patients starting SGLT2 therapy and the drug was discontinued in most cases. All patients required surgery and there was 1 reported death. 

SGLT2 inhibitors are currently approved as adjunct to diet and exercise to lower blood glucose in adults with type 2 diabetes. They work by causing the kidneys to remove sugar from the body through the urine. Approved drugs in the SGLT2 inhibitor class include: 

As a result, the FDA is requiring a new warning be added to the prescribing information and patient Medication Guide of all SGLT2 inhibitors. Healthcare professionals should assess patients for Fournier’s gangrene if they present with symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4ºF, or feel general malaise. 

Treatment should be initiated immediately with broad-spectrum antibiotics and surgical debridement if needed. The SGLT2 inhibitor should be discontinued and the patient’s glucose levels should be closely monitored; alternative treatment for glycemic control should be considered.

B. cepacia Outbreak Tied to No-Rinse Cleaning Foam

 
The FDA is advising consumers and clinicians to avoid using all lots of Remedy Essentials No-Rinse Cleansing Foam.

The FDA is advising customers and clinicians to keep away from utilizing all a number of Treatment Necessities No-Rinse Cleaning Foam.

The Facilities for Illness Management and Prevention (CDC) reported 10 confirmed instances of an infection brought on by Burkholderia cepacia complicated linked to using Medline Treatment Necessities No-Rinse Cleaning Foam. The sufferers had acquired the infections whereas hospitalized for acute situations. 

Thus far, there have been 7 instances reported in Pennsylvania, 2 in California, and 1 in New Jersey. 

In March there was a voluntary recall of Medline Treatment Necessities No-Rinse Cleaning Foam (4oz and 8oz) that have been constructive for presence of B. cepacia. The Meals and Drug Administration (FDA) collected samples from a hospital and distribution heart which examined constructive for B. cepacia; these matched medical isolates obtained from sick sufferers by Pulsed Subject Gel Electrophoresis (PFGE). Individually, an environmental swab collected on the Firm examined constructive for a pressure of B. cepacia. The FDA is continuous to evaluate whether or not different merchandise or tons could pose a threat to customers. 

Because of the exams, the FDA is advising customers and clinicians to keep away from utilizing all a number of Treatment Necessities No-Rinse Cleaning Foam. Along with the beforehand recalled tons (4oz: M06691, M07247 and 8oz: M05703, M06691), the FDA believes further merchandise could also be contaminated. 

Any firm or hospital in possession of the Medline Treatment Necessities No-Rinse Cleaning Foam ought to instantly quarantine the product; sufferers, pharmacies, and all healthcare amenities are advisable to right away discontinue use and allotting.