Navigation Links
Quinolone Vigilance Foundation Supports Citizen Petition Requesting Another Black Box Warning for Levaquin, Cipro, Avelox
Date:9/15/2014

HAMILTON, N.J., Sept. 15, 2014 /PRNewswire-iReach/ -- On September 8, 2014, Dr. Charles Bennett, University of South Carolina, submitted a Citizen Petition to Dr. Margaret Hamburg, FDA Commissioner, asking the FDA to add another Black Box Warning to Levaquin, Cipro, and Avelox antibiotic drug labels.  This request asks for a Black Box Warning for the following psychiatric adverse events:  "toxic psychoses, hallucinations, paranoia, suicidal thoughts or acts, loss of consciousness, delirium, depressed level of consciousness, amnesia, coma, and memory impairment." 

Levaquin, Cipro, and Avelox are in a class of commonly prescribed antibiotics referred to as fluoroquinolones.  They are FDA-approved to treat both routine and serious infections, but are also commonly used for infection prevention and other uses for which the drugs have not been approved by the FDA.

The Black Box request also asks for language explaining that psychiatric adverse events "may start during treatment or may be delayed and start days, weeks, or months after the last dose."  Rachel Brummert, Executive Director of the Quinolone Vigilance Foundation, www.SaferPills.org, a non-profit organization that fosters, initiates, and funds research on fluoroquinolone toxicity, explains that this part of the requested Black Box Warning is important because fluoroquinolone antibiotic adverse events can have a delayed reaction. "Many people do not recognize that their new medical issues are related to the antibiotic they took days, weeks, or months earlier."

Also requested in the Citizen Petition is the addition of a specific heading for "Psychiatric Adverse Events" on the drug labels. "Although there are numerous psychiatric adverse events on the current fluoroquinolone drug labels, they are essentially hidden under the heading, 'Central Nervous System Effects,'" states Brummert.  "Most people would not look under 'Central Nervous System Effects' to find information about suicide, hallucinations, paranoia, or panic attacks. A specific heading for 'Psychiatric Adverse Events' is badly needed."

This Citizen Petition is based on data from the FDA Adverse Events Reporting System (FAERS), as well as data from a survey of individuals who reported having fluoroquinolone adverse events.  Based on the data from these sources, the following psychiatric adverse events, not currently on the drug labels at all, are identified in the Citizen Petition as needing to be added to the fluoroquinolone labels: "feeling abnormal, loss of consciousness, disorientation, agitation, delirium, depressed level of consciousness, amnesia, coma, disturbance in attention, panic attack, memory impairment, and nervousness." 

Dr. Bennett submitted another Citizen Petition to the FDA in June requesting a Black Box warning be added to the Levaquin label which would advise doctors and patients of possible Mitochondrial Toxicity, which has been implicated in such serious neurodegenerative diseases as Parkinson's, Alzheimer's, and ALS.  The FDA has not yet responded to this Citizen Petition.

John Fratti, FDA Patient Representative, Drug Safety, and strong advocate for additional fluoroquinolone drug warnings, stresses the importance of making the changes requested by both Citizen Petitions submitted by Dr. Bennett.  "Levaquin, Cipro, and Avelox have negatively affected thousands of individuals. These important label changes will disclose adverse events so doctors and patients can make informed decisions before they take these antibiotics." 

Brummert agrees with Fratti and states, "These drug label changes related to both possible mitochondrial toxicity and psychiatric adverse events, as outlined in the two Citizen Petitions, are needed immediately. The Quinolone Vigilance Foundation is calling on Dr. Hamburg, the FDA, and fluoroquinolone drug makers to take action now and not wait until more people suffer irreversible, but preventable harm."

Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839, rachel@saferpills.org

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE Quinolone Vigilance Foundation
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Kalidex Introduces Novel Fluoroquinolone, KPI-10, at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
2. Pharmacovigilance Market [Clinical Trial Phases (Pre-Clinical Studies, Phase I, Phase II, Phase III, Phase IV or Post-Marketing Surveillance) and Service Providers (In-House and Contract Outsourcing] - Global Industry Analysis, Size, Share, Growth,
3. Pi2 Solutions Presents on Pharmacovigilance Literature Screening at Major European Risk Management Meeting
4. CPhI Report Indicates a Need for Greater Third Party Certification to Ensure GMP Vigilance
5. Cadence Health Foundation Commits $3.1 million To Support Services At Central DuPage Hospital and Delnor Hospital
6. Infinite Hero Foundation Announces Inaugural Veterans Innovation Summit for Investing & Technology (VISIT) to Improve the Lives of Military Veterans
7. Touro University California Garners Grant From Long Foundation
8. The Galien Foundation Announces 2014 Prix Galien USA Nominees for "Best Biotechnology Product," "Best Pharmaceutical Agent," and "Best Medical Technology"
9. Lightlake Therapeutics Inc. Receives Funding Commitment From A Prominent International Research And Development Foundation
10. Essentialis Secures Foundation for Prader-Willi Research Grant to Help Advance DCCR in the Treatment of Prader-Willi Syndrome
11. Fragile Kids Foundation Announces $125,000 Grant from the James M. Cox Foundation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/13/2018)... (PRWEB) , ... September 13, 2018 , ... ... HomeCare and Hospice, effective August 31, 2018, making its regional Texas Home Health ... the state including home health, hospice, and personal care services. , Texas ...
(Date:9/12/2018)... (PRWEB) , ... September 12, 2018 , ... Lifetime ... senior living communities, announces the launch of a new online store to offer exclusive ... all ages. , “We’re thrilled to open our online store to offer our ...
(Date:9/7/2018)... ... September 07, 2018 , ... Elaine Uonelli, a ... a gripping narrative that shows the author’s experience of encountering with Burkitt lymphoma—an ... writes an eventful life that revolves around a disease with a lasting impact ...
Breaking Medicine Technology:
(Date:9/13/2018)... BOSEMAN, Mont. (PRWEB) , ... September 13, 2018 , ... ... 4th Annual Health IT + Revenue Cycle Conference on September 19-22 in Chicago. ... two separate panels as well as a talk titled, “Your Clinical Communication & Collaboration ...
(Date:9/12/2018)... , ... September 12, 2018 , ... Today, Sterling ... and Maureen Beck, attempted the first unassisted adaptive climb of the Lotus Flower Tower ... which made it difficult for him to lead, the duo decided to persevere and ...
(Date:9/12/2018)... ... 2018 , ... Donaldson Plastic Surgery has been included on the Inc. 5000 ... 50 list of central Ohio's fastest growing businesses. The plastic surgery practice was ranked ... It is the only medical practice and plastic surgery office to make the regional ...
(Date:9/7/2018)... ... September 07, 2018 , ... Modere, ... with a presence worldwide, today announced that its Chief Executive Officer, Asma Ishaq, ... Ms. Ishaq will be presented the award on Friday, September 7, at the ...
(Date:9/7/2018)... Calif. (PRWEB) , ... September 07, 2018 , ... ... Positas Community College District , the only OSHA authorized OTI Education Center headquartered ... to assist employees who feel they have experienced retaliation in response to ...
Breaking Medicine News(10 mins):