Anavex Life Sciences Corp (AVXL)

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Sorry, JAMA agrees with me ....

Introduction
Fluoroquinolones are a class of broad-spectrum antibiotics that have been commonly prescribed at increasing rates since they became available in the late 1980s. However, concerns have been raised because they present a risk for toxic effects and potential inappropriate use.1-3

Fluoroquinolones are associated with serious adverse events affecting the musculoskeletal, peripheral nervous, and central nervous systems,4 with more recent evidence of aortic dissection or aneurysm.5 In August 2013, after receiving numerous reports of adverse events, the US Food and Drug Administration (FDA) issued a warning that highlighted the risk of irreversible peripheral neuropathy (serious nerve damage). In May and July 2016, the FDA revised its fluoroquinolones black box warning to further address these serious safety issues.6,7 With these warnings, the FDA recommended limited use of fluoroquinolones for acute sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infection (UTI), contending that the risks of serious adverse effects generally outweigh the benefits for patients with these conditions.

Even as appropriate antibiotic prescribing became a priority,8 evidence is mixed on the ability of FDA warnings to reduce prescribing of this class of drugs for these 3 conditions. Some studies showed that prescribing fluoroquinolones for uncomplicated UTIs, acute sinusitis, and acute bronchitis has not substantially changed after the 2016 warning,9,10 calling for better methods to disseminate FDA warnings. By contrast, studies that involved 29 southeastern US hospitals11 and a national sample of privately insured patients12 reported that inpatient prescribing of fluoroquinolones has been declining consistently in trends and in levels across specialties for certain conditions since the 2013 and 2016 warnings.

Discontinuing the prescription of ineffective drugs is also not uniform across all types of prescribers. Some specialties adopt evidence faster than others.12 In addition, there may be systematic differences in prescriber behavior on the basis of hospital characteristics, such as teaching status, ownership, and case mix index (CMI).13,14

To our knowledge, the present study was the first to build a patient cohort using a 20% random sample of Medicare fee-for-service beneficiaries. We aimed to analyze changes in prescribing of fluoroquinolones after the 2013 and 2016 FDA warnings as well as to examine the physician characteristics associated with these changes. The analysis focused on 3 periods: before the 2013 warning (baseline period), after the 2013 warning but before the 2016 warning (postwarning period 1), and after the 2016 warning (postwarning period 2). We also sought to ascertain whether variations in de-adoption (defined as the discontinuation of a clinical practice after it was previously adopted, especially because of ineffective and harmful practices)15-19 existed across organizational affiliations and specialties, identifying areas wherein inappropriate prescribing has persisted, which can ultimately lead to improved patient safety.

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2786698