warning: fluoroquinolones and aortic dissection


The FDA just issued an alert about fluoroquinolones and the high incidence of aortic dissections or ruptured aortic aneurysms (see https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm628960.htm )

Details:
--the overall rate of aortic aneurysm/dissection varies by the population assessed: one study estimated risk at 9/100,000 persons in the general population, up to 300/100,000 in those at highest risk (eg >85yo)
--there was a pretty high risk of aortic aneurysm/dissection in a 2015 study, with rate ratio of 2.28 (1.67-3.13), confined to patients with other risk factors (smoking, male gender, older age, hypertension, and atherosclerosis). but the FDA thought there were design flaws in that study
--4 additional epidemiological studies, however, found an increased risk, though most studies were small
--a secondary analaysis of one of these studies found that the increased risk occurred mostly in the first 10 days of fluoroquinolones, with no increased risk from days 61-120
--another study found an increased risk if exposure was present in the first 3-14 days (OR 2.41). though slightly higher after 14 days of treatment (OR 2.83)
--based on the confluence of eepidemiological studies, they recommend: we "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". and use them only if absolutely necessary

--of note, this is the 5th safety concern about fluoroquinolones, including
    --warnings about hypoglycemia (esp in diabetics on meds and the elderly), including resulting in coma or other psychiatric adverse reactions, even after only one dose (July 2018: https://www.fda.gov/Drugs/DrugSafety/ucm611032.htm )
    --a general warning, stressing that there are potentially permanent efffects on tendons, muscles, joints, nerves and CNS. and these drugs should NOT be used for infections responsive to other meds (esp acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated UTIs (July 2016: https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm )
    --another general warning regarding neuropathy, confusion, hallucinations (May 2016: https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm )
    --permanent nerve damage from peripheral neuropathy (August 2013: http://wayback.archive-it.org/7993/20170112031629/http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm )
    --tendinitis and tendon rupture, esp if >60yo and on steroids. including Achilles, shoulder, hand and other tendons (July 2008: http://wayback.archive-it.org/7993/20170112032310/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm )

--and, of course, pretty profound effects on the poor little microbiome…..  and, ciprofloxacin is one of the most common cause of C diff infections

For those newer blog readers, there have been a slew of relevant prior blogs related to the overuse of antibiotics (especially broad spectrum ones) as well as the microbiome (risk factors for adverse changes, effects of microbiome on general health issues):
--antibiotics: see http://gmodestmedblogs.blogspot.com/search?q=antibiotics
--microbiome: see http://gmodestmedblogs.blogspot.com/search?q=microbiome 

geoff​

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