Myasthenia gravis black box warning – Fluoroquinolones.

admin — Sun, 08 Jan 2012 18:42:20 +0000

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

Citizen’s Petition against the FDA.

admin — Mon, 04 May 2009 14:47:03 +0000

I am going to try and write a Citizen’s petition against the FDA for stricter warnings for fluoroquinolone antibiotics. I am not really sure how to go about this. I posted a link below that explains most of this process. I googled “How to do a citizen’s petition to the FDA” and the link below came up. A couple of fluoroquinolone victims in the state of Illinois were successful in petitioning the FDA for tendon warnings. They were able to get the Attorney General in their state to issue the petition and get the Public Citizen organization to join them in the petition against the FDA.

There are two important issues that I think should be addressed in a petition for fluoroquinolones:

The “black box” warning that has already been issued is good but still not adequate because the warning is only on the package insert at the pharmacy and not on the prescribing literature that people get when they pick up their prescription. Since nobody receives the package insert nobody really knows that there is a “black box” warning for these antibiotics. People deserve the right of informed consent before taking something as dangerous as a fluoroquinolone. A petition to the FDA needs to be made to have the “black box” warning for fluoroquinolones be put on the prescribing literature that people receive when they get their prescription. People should have the right to make their own decision based on adequate information on the benefits and risks of fluoroquinolones.

The second warning that needs to be placed on fluoroquinolones is for a “black box” warning to be issued for central nervous system damage that can result from these antibiotics. A “black box” warning needs to be issued on the prescribing literature for prolonged or long term insomnia, anxiety, mood changes, panic attacks. I am not sure of what the correct wording for this should be. I will have to think about exactly how this should be stated and then post this on a later blog. I actually think that the incidence of central nervous system damage is higher than the incidence of tendon disorders. That is just my opinion though.

I will have to contact the Pennsylvania Attorney General’s office to try and get them to issue a “black box” warning. I think it will be easier if I write the petition and just try and get the Attorney General’s office approve it. Their staff people are so busy that if I can do the leg workfor this maybe there will be a better chance of them going along with it. Maybe I should also try and call Public Citizen to see if they will join in the petition. I will have to show the Pennsylvania Attorney General’s office the petition from the Illinois Attorney General’s office so that there is a higher likelihood of them going along with this. I need to think this whole thing through so that I do this in the best manner. I know some floxed people here in Pennsylvania and maybe I can get them to join in this effort. Unfortunately my dad has been having leg pain and weakness for about a month or two so I am helping my mother care for him. This is taking time away from some of my advocacy efforts. Plus my own illness from the Levaquin poisoning is taking lots of time up.

http://www.fda.gov/ora/fed_state/Small_business/sb_guide/petit.html

"Levaquin Hurts" Brain/Body Toxic Drug » Black Box warning- Quinolones