#FDA Drug Safety Communication: FDA updates warnings for oral and injectable #fluoroquinolone antibiotics due to disabling side effects
https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm?source=govdelivery&utmmedium=email&utmsource=govdelivery
05-10-2017 As part of our ongoing review of fluoroquinolone antibiotics, FDA is informing the public that patient cases identified by the FDA and findings from published studies currently do not support reports that these medicines may result in detachment of the retina in the eyes, or bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection. We will continue to assess safety issues with fluoroquinolones and will update the public if additional actions are needed.
https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm?source=govdelivery&utmmedium=email&utmsource=govdelivery
05-10-2017 As part of our ongoing review of fluoroquinolone antibiotics, FDA is informing the public that patient cases identified by the FDA and findings from published studies currently do not support reports that these medicines may result in detachment of the retina in the eyes, or bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection. We will continue to assess safety issues with fluoroquinolones and will update the public if additional actions are needed.
#Fluoroquinolone use and risk of aortic #aneurysm and dissection: nationwide cohort study
http://www.bmj.com/content/360/bmj.k678
Within the 60 day risk period, the rate of aortic aneurysm or dissection was 1.2 cases per 1000 person years among fluoroquinolone users and 0.7 cases per 1000 person years among amoxicillin users. Fluoroquinolone use was associated with an increased risk of aortic aneurysm or dissection (hazard ratio 1.66 (95% confidence interval 1.12 to 2.46)), with an estimated absolute difference of 82 (95% confidence interval 15 to 181) cases of aortic aneurysm or dissection by 60 days per 1 million treatment episodes. In a secondary analysis, the hazard ratio for the association with fluoroquinolone use was 1.90 (1.22 to 2.96) for aortic aneurysm and 0.93 (0.38 to 2.29) for aortic dissection.
Conclusions In a propensity score matched cohort, fluoroquinolone use was associated with an increased risk of aortic aneurysm or dissection. This association appeared to be largely driven by aortic aneurysm
http://www.bmj.com/content/360/bmj.k678
Within the 60 day risk period, the rate of aortic aneurysm or dissection was 1.2 cases per 1000 person years among fluoroquinolone users and 0.7 cases per 1000 person years among amoxicillin users. Fluoroquinolone use was associated with an increased risk of aortic aneurysm or dissection (hazard ratio 1.66 (95% confidence interval 1.12 to 2.46)), with an estimated absolute difference of 82 (95% confidence interval 15 to 181) cases of aortic aneurysm or dissection by 60 days per 1 million treatment episodes. In a secondary analysis, the hazard ratio for the association with fluoroquinolone use was 1.90 (1.22 to 2.96) for aortic aneurysm and 0.93 (0.38 to 2.29) for aortic dissection.
Conclusions In a propensity score matched cohort, fluoroquinolone use was associated with an increased risk of aortic aneurysm or dissection. This association appeared to be largely driven by aortic aneurysm
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FDA updates #warnings for #fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612995.htm?utm_campaign=07102018_PR_FDA%20updates%20warnings%20for%20fluoroquinolone%20risks&utm_medium=email&utm_source=Eloqua
Across the fluoroquinolone antibiotic class, a range of mental health side effects are already described in the Warnings and Precautions section of the drug labeling, but differed by individual drug. The new class-wide labeling changes will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class. The mental health side effects to be included in the labeling across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.
Additionally, the recent FDA review found instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia. As a result, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.
FDA updates #warnings for #fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612995.htm?utm_campaign=07102018_PR_FDA%20updates%20warnings%20for%20fluoroquinolone%20risks&utm_medium=email&utm_source=Eloqua
Across the fluoroquinolone antibiotic class, a range of mental health side effects are already described in the Warnings and Precautions section of the drug labeling, but differed by individual drug. The new class-wide labeling changes will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class. The mental health side effects to be included in the labeling across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.
Additionally, the recent FDA review found instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia. As a result, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.
!!
#Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the #Aorta Blood Vessel in Certain Patients
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm628960.htm
RECOMMENDATION:
Healthcare professionals should:
Avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.
Prescribe fluoroquinolones to these patients only when no other treatment options are available.
Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.
Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.
#Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the #Aorta Blood Vessel in Certain Patients
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm628960.htm
RECOMMENDATION:
Healthcare professionals should:
Avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.
Prescribe fluoroquinolones to these patients only when no other treatment options are available.
Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.
Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.
!!
Pandemic uropathogenic #fluoroquinolone-resistant #Escherichia coli have enhanced ability to persist in the gut and cause bacteriuria in healthy women
https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciz547/5528138
We report that fluoroquinolone resistant Escherichia coli are found in feces of 8.8% healthy adult women, with most bacteria belonging to pandemic multi-drug resistant ST131-H30R or ST1193 clonal groups.
Moreover, these highly uropathogenic clonal groups demonstrate an especially prolonged gut persistence and high rate of bacteriuria without documented UTI.
Pandemic uropathogenic #fluoroquinolone-resistant #Escherichia coli have enhanced ability to persist in the gut and cause bacteriuria in healthy women
https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciz547/5528138
We report that fluoroquinolone resistant Escherichia coli are found in feces of 8.8% healthy adult women, with most bacteria belonging to pandemic multi-drug resistant ST131-H30R or ST1193 clonal groups.
Moreover, these highly uropathogenic clonal groups demonstrate an especially prolonged gut persistence and high rate of bacteriuria without documented UTI.
OUP Academic
Pandemic Uropathogenic Fluoroquinolone-resistant Escherichia coli Have Enhanced Ability to Persist in the Gut and Cause Bacteriuria…
Abstract. We report that fluoroquinolone-resistant Escherichia coli are found in feces of 8.8% of healthy women, with most bacteria belonging to pandemic multi
Association of #Fluoroquinolone Use With Short-term Risk of Development of Aortic #Aneurysm
https://2medical.news/2021/01/09/association-of-fluoroquinolone-use-with-short-term-risk-of-development-of-aortic-aneurysm/
Although fluoroquinolones are commonly prescribed antibiotics in the US, recent international studies have shown an increased risk of aortic aneurysm and dissection after fluoroquinolone use, leading to US Food and Drug Administration warnings limiting use for high-risk patients. It is unclear whether these data are true for the US population and who is truly high risk.. ..Of 47 596 545 prescription fills, 9 053 961 (19%) were fluoroquinolones and …
https://2medical.news/2021/01/09/association-of-fluoroquinolone-use-with-short-term-risk-of-development-of-aortic-aneurysm/
Although fluoroquinolones are commonly prescribed antibiotics in the US, recent international studies have shown an increased risk of aortic aneurysm and dissection after fluoroquinolone use, leading to US Food and Drug Administration warnings limiting use for high-risk patients. It is unclear whether these data are true for the US population and who is truly high risk.. ..Of 47 596 545 prescription fills, 9 053 961 (19%) were fluoroquinolones and …