Quinolone Vigilance Foundation Supports Citizen Petition Requesting Another Black Box Warning for Levaquin, Cipro, Avelox
FDA and Drug Makers Asked to Expand Warnings about Psychiatric Adverse Events Risk
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
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