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

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SOURCE Quinolone Vigilance Foundation