Myasthenia gravis black box warning – Fluoroquinolones.

I believe this is the study that led to the myasthenia gravis black box warning for Fluoroquinolones. It was three FDA staff who looked at the MedWatch data and published a paper.  Jeez, what a concept!  It seems like it may be worth a try to contact these three individuals and suggest they look at more of the FQ MedWatch data. Especially peripheral neuropathy. I sent an email to the one author listed below about FQ peripheral neuropathy but didn’t get a reply. Maybe others would be more successful.  Thank you for your FQ advocacy.   
 
 
Drug Saf. 2011 Oct 1;34(10):839-47. doi: 10.2165/11593110-000000000-00000.

Fluoroquinolone-associated myasthenia gravis exacerbation: evaluation of postmarketing reports from the US FDA adverse event reporting system and a literature review.

Jones SC, Sorbello A, Boucher RM

Source

US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of Pharmacovigilance II, Silver Spring, MD 20993, USA.

Abstract

BACKGROUND:

Exacerbations of myasthenia gravis have been reported in antibacterial-treated patients. In animal and in vitro models of experimentally-induced myasthenia gravis, fluoroquinolones exhibit neuromuscular blockade.

OBJECTIVE:

The aim of this retrospective study was to evaluate postmarketing adverse event reports submitted to the US FDA and case reports published in the scientific literature for a potential association between fluoroquinolone exposure and acute exacerbations of myasthenia gravis.

METHODS:

On 1 March 2011, we searched the FDA Adverse Event Reporting System (AERS) database to retrieve all reports of myasthenia gravis exacerbation as a serious adverse event in patients treated with fluoroquinolones. We also conducted an Internet-based search using EMBASE for additional English-language cases in the scientific literature.

RESULTS:

We identified a total of 37 unique cases describing myasthenia gravis exacerbation following fluoroquinolone systemic exposure. We retrieved AERS reports for 27 non-ventilated patients administered the following fluoroquinolones: levofloxacin (n = 9), moxifloxacin (n = 6), ciprofloxacin (n = 6), ofloxacin (n = 2), gatifloxacin (n = 2), norfloxacin (n = 1) and trovafloxacin (n = 1). Additionally, we retrieved ten case reports published in the literature involving non-ventilated patients administered ciprofloxacin (n = 4), levofloxacin (n = 2) and ofloxacin, norfloxacin, pefloxacin and prulifloxacin (1 patient each). Myasthenia gravis exacerbations developed a median of 1 day following fluoroquinolone exposure. The 37 cases describe dyspnoea (n = 19; 51%), myasthenic crisis requiring ventilatory support (n = 11; 30%) and death (n = 2; 5%). Additional exacerbation-related adverse events were generalized muscle weakness (n = 20; 54%), dysphagia (n = 9; 24%), diplopia (n = 6; 16%) and ptosis (n = 6; 16%). Six patients (16%) experienced a positive rechallenge, with recurrent myasthenia gravis exacerbation after fluoroquinolone reintroduction.

CONCLUSIONS:

Fluoroquinolone exposure may result in potentially life-threatening myasthenia gravis exacerbations in patients with underlying disease. Healthcare professionals should be aware of this serious drug-disease association and carefully weigh the benefit-risks of fluoroquinolones when treating infections in non-ventilated myasthenic patients.

 

Here is the contact information for one of the three FDA authors.


Last name Sorbello
 
First name Alfred
 
Middle name F
 
Agency FDA
 
Organization DHHS/FDA/CDER/OSE/OPE/DPV II
 
Job title MEDICAL OFFICER
 
Building WO22
 
Room 3460
 
Duty station Silver Spring MD 20993
 
Mail stop HFD-520
 
Phone 301-796-0816
 
Internet e-mail
alfred.sorbello@fda.hhs.gov
 

 
 

 

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