Psychiatric Warning Should Join Antibiotic Peripheral Neuropathy Warnings, According to FDA Citizen Petition

Amid mounting concerns about the risk of peripheral neuropathy from antibiotics like Levaquin, Cipro, Avelox and others, a citizen petition has been filed with the FDA calling for a new black box warning for the entire class of medications to alert users to the risk of psychiatric problems, as well as nerve damage.

Dr. Charles Bennett, of the University of South Carolina, submitted a citizen petition to the FDA last week, calling for the entire class of antibiotics known as fluoroquinolones to receive a new boxed warning, which is the strongest warning the agency can require drugs to carry.

According to the petition, consumers should be provided stronger warnings about the potential pyschiatric side effects of Levaquin, Cipro, Avelox and other members of the same class of drugs, which have been linked to problems like hallucinations, paranoia, amnesia, suicidal thoughts and other mental side effects.

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Earlier this summer, Dr. Bennett and the Southern Network on Adverse Reactions (SONAR) filed a similar petition calling for a black box warning on mitochondrial toxicity for the antibiotics, which can lead to severe nerve problems, such as peripheral neuropathy and other health problems.

The petitions have been supported and promoted by the Quinolone Vigilance Foundation, an activist group formed of former antibiotics users who suffered severe side effects after taking the drugs. The group announced the latest citizen petition in a press release on September 15.

Dr. Bennett warns that psychiatric adverse events linked to the use of Cipro, Levaquin and similar antibiotics are a major problem. He calls for a black box warning that advises users that the psychiatric side effects could start during treatment, or may not appear until days, weeks or even months after patients have taken the last dose.

“Although there are numerous psychiatric adverse events on the current fluoroquinolone drug labels, they are essentially hidden under the heading, ‘Central nervous System Effects,’” Rachel Brummert, Executive Director of the Quinolone Vigilance Foundation, said in the┬ápress release. “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.”

Antibiotic Peripheral Neuropathy Risk

The psychiatric concerns come as concerns have continued to increase about the link between fluoroquinolone antibioitics and perhipheral neuropathy, which can cause long-lasting and permanent nerve damage for some users.

Symptoms of peripheral neuropathy from Levaquin, Cipro, Avelox and other related drugs may include pain, burning, tingling, numbness, weakness, and sensitivity to light touches, temperature and motion in the arms and legs.

In August 2013, the FDA issued a drug safety communication warning about the risk of peripheral neuropathy from the antibiotics, suggesting that the problems may surface at any time after using the drugs and may continue for months or years after the medication is discontinued.

The FDA required the drug makers to add new warnings and information to the antibiotic labels, indicating that individuals should seek medical treatment if they experience symptoms of peripheral neuropathy and encouraging doctors to switch patients to another antibiotic from a different class if nerve damage is suspected.

Researchers Back FDA Findings

The peripheral neuropathy warning came as new research appeared to strengthen the connection between Levaquin and similar drugs and nerve damage that could be permanent in some cases.

About two months after the SONAR petition, filed in June, researchers from the University of British Columbia found that new users of oral fluoroquinolones could have twice the risks of suffering peripheral neuropathy as their peers who do not take the drugs.

The findings, published on August 22 in the medical journal Neurology, appeared to support warnings issued by the FDA last year, indicating that all fluoroquionolones may carry a peripheral neuropathy risk.

Dr. Bennett warns that the cause may be mitochondrial toxicity, which has been linked to a number of neurodegenerative diseases, such as Parkinson’s Disease, and ALS.

Fluoroquinolones are among of the most widely used antibiotics in the United States, including Levaquin, Cipro, Avelox, Noroxin, Floxin and Factive. The class has already been linked to a potential risk of tendon ruptures, retinal detachment, and possible kidney problems.

According to the FDA, there are about 23.1 million patients who received a prescription for an oral fluoroquinolone in 2011. Cipro dominated the market, comprising 70% of those prescriptions, followed by Levaquin or a generic equivalent, which was used by 28%. Another 3.8 million patients received injections in 2011, with Levaquin or a generic equivalent making up 63% of those, followed by Cipro at 28%.

A number of former users who have experienced problems with peripheral neuropathy or psychiatric problems after using the antibiotics are now considering Levaquin lawsuits, Cipro lawsuits and Avelox lawsuits against the manufacturers, alleging that insufficient warnings have been provided for consumers and the medical community for years.

3 Comments

  • LenoraSeptember 24, 2014 at 2:55 am

    Fluoride is a BIG business in all it's forms. There is no way it will ever go away no matter how many people have to suffer.

  • Rachel BrummertSeptember 23, 2014 at 5:21 am

    Mr Jackson, On behalf of Quinolone Vigilance Foundation, and as its Executive Director, please allow me to say thank you for writing this important article. Quinolone Vigilance Foundation supports the Citizen Petitions submitted by Dr. Charles Bennett. The failure by the FDA and drug makers to adequately warn the public puts patients at an alarmingly high risk of developing life-threatening neu[Show More]Mr Jackson, On behalf of Quinolone Vigilance Foundation, and as its Executive Director, please allow me to say thank you for writing this important article. Quinolone Vigilance Foundation supports the Citizen Petitions submitted by Dr. Charles Bennett. The failure by the FDA and drug makers to adequately warn the public puts patients at an alarmingly high risk of developing life-threatening neurodegenerative disorders and psychiatric effects. We call on the FDA and drug makers to protect the public and issue these important warnings immediately. I took Levaquin in 2006 and have had nine tendon ruptures, developed peripheral neuropathy, and in 2010 was diagnosed with a neurodegenerative disease. There are patients worldwide who suffer these same adverse reactions. Adding these new warnings will help educate doctors and patients so they can make an educated decision about their treatment options without putting them at unnecessary risk. In addition to this being terrifying for adults to go through, I would be remiss if I did not also mention that these drugs are given to children. For more information, please read: HAMILTON, N.J., Sept. 16, 2014- Quinolone Vigilance Foundation (QVF) has asked the FDA to investigate whether the fluoroquinolone antibiotic, Levaquin, could be related to the onset of paralysis or polio-like symptoms in California children. Comments were submitted to Dr. Walter Ellenberg for the FDA Pediatric Advisory Committee meeting on September 23, 2014 in Bethesda, Maryland. QVF, a non-profit organization that fosters, initiates, and funds research on fluoroquinolone toxicity, has also requested that the FDA reconsider the overall use of Levaquin for the pediatric population. Although, as indicated on the Levaquin label, "Levaquin is indicated in pediatric patients (6 months of age and older) only for the prevention of inhalational anthrax (post-exposure) and for plague," Levaquin clinical trials were conducted on children with other conditions such as, pneumonia and acute otitis media. One such Levaquin pediatric clinical trial, described on the U.S. National Institutes of Health (NIH) website, was conducted from 2002 to 2010 and enrolled approximately 2,233 children, ages 6 months to 16 years old, in 63 study locations. According to the NIH website, the "Study Sponsor" is Johnson & Johnson, the maker of Levaquin. Additionally, regarding this Levaquin pediatric clinical trial, NIH documents "Information provided by (responsible parties)" is Johnson & Johnson. "QVF is concerned that physicians are using Levaquin to treat children off-label in ways not approved by the FDA," states QVF's Executive Director Rachel Brummert. "We are also concerned that physicians and parents are depending on clinical trials that are closely associated with Johnson & Johnson, the study sponsor of the clinical trials and the maker of Levaquin. We want the FDA to seriously consider the impact of using Levaquin, an extremely potent antibiotic with identified serious adverse events, on children." Based on these concerns, QVF submitted the following comments to the FDA Pediatric Advisory Committee: COMMENT #1: Please reconsider the use of Levaquin for the pediatric population based on the April 17, 2013 FDA report and the Citizen Petition submitted to Dr. Hamburg asking for an immediate Levaquin Black Box Warning for possible Mitochondrial Toxicity. As described by the FDA, peripheral neuropathy may be permanent and neurodegenerative diseases, such as Parkinson's, Alzheimers, and ALS are life-ending. COMMENT #2: Please reconsider the use of Levaquin for the pediatric population based on FAERS [FDA Adverse Events Reporting System] psychiatric adverse events data, QVF survey data, and the Citizen Petition to be submitted to Dr. Hamburg asking for an immediate Levaquin Black Box Warning regarding Serious Psychiatric Events. COMMENT #3: Please reconsider the use of Levaquin for the pediatric population based on FAERS suicidal ideation adverse events data, QVF survey suicidal thoughts data, and the Citizen Petition to be submitted to Dr. Hamburg asking for an immediate Levaquin Black Box Warning regarding Serious Psychiatric Events, which includes language regarding suicidal thoughts or acts. COMMENT #4: Please contact Dr. Keith Van Haren, Lucile Packard Children's Hospital, Stanford and Dr. Emmanuelle Waubant, University of California, San Francisco who have both been involved with children in California who have "mysterious" paralysis or polio-like symptoms. Please investigate how many, if any, of the approximate 25 children in California who appeared to have developed "mysterious" paralysis or polio-like symptoms had consumed Levaquin in the days or months prior to paralysis or polio-like illness onset. Comment #4 is based on a February 24, 2014, news story, "Doctors Probe Polio-Like Illness in California Kids." In its comments to the FDA Pediatric Advisory Committee, QVF quotes the ABC story: "Sofia's problems began when her parents noticed she was having trouble breathing. After treatment by her pediatrician didn't help, Sofia spent four days in the hospital, but her breathing was still not completely clear. Her doctor suspected it might be pneumonia and gave her an antibiotic, but as the family was leaving the doctor's office the little girl reached her left hand out for a toy, and, her mother said, 'mid-grasp her left hand dropped.'" QVF is asking the FDA to investigate whether the antibiotic for possible pneumonia given to Sophia prior to the onset of paralysis or polio-like symptoms could have been Levaquin. As the QVF comments explain, "FDA Levaquin FAERS data include 44 reports of 'paralysis' between November 1997 and January 2010. If only 1% to 10% of actual adverse events are reported to FAERS, the actual number of Levaquin paralysis adverse events could be 440 to 4,400." As pointed out by Brummert, "this data suggests the need for FDA investigation." As identified on the draft agenda from the FDA website, the FDA Pediatric Advisory Committee will discuss "Justified Abbreviated Review of Adverse Events," related to five drugs, including the fluoroquinolone antibiotic, Levaquin (levofloxacin). Per the agenda, this discussion will led by FDA Supervisory Medical Director, Dr. Judith Cope. Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839, rachel@saferpills.org

  • LisaSeptember 23, 2014 at 3:59 am

    Stephen Fried's book, "Bitter Pills: Inside the Hazardous World of Legal Drugs," in which Mr. Fried described his wife Diane's onset of bipolar disorder after taking Floxin, a fluoroquinolone with the same effects as Cipro, Levaquin, Avelox and all other fluoroquinolones, came out more than 16 years ago. It's about time the effects of fluoroquinolones on mental health are recognized. Here is an [Show More]Stephen Fried's book, "Bitter Pills: Inside the Hazardous World of Legal Drugs," in which Mr. Fried described his wife Diane's onset of bipolar disorder after taking Floxin, a fluoroquinolone with the same effects as Cipro, Levaquin, Avelox and all other fluoroquinolones, came out more than 16 years ago. It's about time the effects of fluoroquinolones on mental health are recognized. Here is an article about how fluoroquinolones induce mitochondrial damage, which leads to oxidative stress, which leads to psychiatric illness - http://www.hormonesmatter.com/antibiotics-psychiatric-reactions/

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