While the news about taking too many antibiotics is now common knowledge, there is another underlying danger that the public is not aware of. As beneficial as this class of drugs are, there is a widely prescribed family of antibiotics that is highly destructive. Called fluoroquinolones, they are better known under the names Cipro and Levaquin (as well as four others). What You Must Know About the Hidden Dangers of Antibiotics, has two main goals. The first is to expose the truly destructive capability of these drugs to cause serious, sometimes long term and permanent injuries. The capacity of these drugs for such damage has been attested to by the government’s own watchdog agency, the FDA. Hundreds of patients, many of whom are quoted in this book, have confirmed their long-lasting injuries to the book’s author, Dr. Jay Cohen, while many hundreds more have been ignored or dismissed by their own physicians. As this book will show, being brushed off and dismissed as simple side effects essentially allows these manufactures to hide these problems from public view.
The second goal of this book is to provide other safer and effective remedies, solutions, and considerations that may help end the suffering experienced by patients suffering from these dangerous side effects--that can affect many human systems including the musculoskeletal, nervous, psychiatric, gastrointestinal, and others. To do this we explain how these dangerous antibiotics work, and particularly how they injure. By understanding the underlying problems, the alternatives offered in this book can help people potentially reduce their pain reduction, clear up persistent antibiotic-based health issues, and just as important, give them hope.
Because so many doctors do not carefully read the FDA’s dire warnings about the risks these specific antibiotics pose, there is little likely patients will be know why they are having such serious reactions. With What You Must Know About the Hidden Dangers of Antibiotics, they may have the answer they are looking for.
Open Letter to the Senate Committee on Health, Education & Labor
Serious adverse reactions to fluoroquinolone antibiotics (FQs) have been reported in medical journals and to the FDA since the 1980s. Although the FDA has increased the warnings on these drugs, my analysis of the data shows that reports continue to climb in number. As of February 2014, approximately 45,000 individual cases of fluoroquinolone toxicity have been reported. And, as studies have proven, the FDA receives reports of only one to 5 percent of the actual numbers of adverse reactions that occur.
I have been following these medications for sixteen years and have evaluated in person or by telephone consultation more than 500 people injured by FQs. In 2001, I published an article, “Peripheral Neuropathy with Fluoroquinolone Antibiotics” in the peer-reviewed journal, Annals of Pharmacotherapy. This article described forty-five cases of neurological symptoms such as tingling, numbness, burning pain, twitching, and/or weakness. Moreover, 93 percent of agitation, impaired cognitive function, intractable insomnia, hallucinations, psychosis, acute manic episodes, joint or muscle pain, or tendon rupture. In many cases, toxicities also involved the cardiovascular and gastrointestinal systems, skin, and sight or hearing. Overall, 90 percent of my subjects experienced toxicity to multiple body systems, hence I have coined the term: fluoroquinolone toxicity syndrome (FTS).
Of greatest concern, the majority of my cases had lasted more than one to two years and were ongoing. These severe, long-term reactions occurred in a generally young and healthy population. The average patient was forty-two, many of them athletes. In fact, top athletic organizations now warn athletes to avoid treatment in FQs. Because of the impaired healing seen in severe FTS patients, we have long suspected genetic injury from FQs. These drugs were designed to injure the genetic structure of bacteria and thereby kill them, and they are very efficient in doing so. However, testing was never performed to ensure that FQs do indeed injure human DNA. Further study on this must now be undertaken.
There is no doubt that fluoroquinolones are important medications that help many thousands of people each year, but the indiscriminate prescribing of these highly potent “big gun” antibiotics for everyday minor infections such as sinusitis, sore throats, or bladder infections is unnecessary and medically unsafe. Medical authorities have repeatedly denounced the overuse of FQs. In my forty-plus years in pharmacovigilance, FQs surpass Vioxx and thalidomide in the degree of permanent harm done.
FDA warnings currently describe many of the adverse effects of FQs. Recently the FDA has finally acknowledged that FQs can cause permanent injury. However, FDA warnings do not adequately describe FTS syndrome, so doctors do not consider FTS a possible culprit for patients’ symptoms. Instead, they waste valuable time and order expensive testing for rare neurologic or rheumatologic disorders while discontinuing or dismissing patients who are suffering severely from FTS. The warnings must be improved and the word about FTS must be spread nationally and worldwide. It can start with you.
Jay S. Cohen, M.D.
Suppose you develop a bladder or sinus infection and go to your doctor. Let’s say your doctor does the right thing by informing you fully, saying, “Cipro is the best drug for this problem. However, drugs like Cipro are believed to cause more than 55,000 serious, sometimes disabling, sometimes permanent reactions each year. Do you still want to take it?” Would you say, “Yes, please?” Not likely. Yet, Cipro and other antibiotics just like it are prescribed to patients every day, often for minor afflictions that do not warrant the use of such a powerful drug.
Introduced in 1987 as the first oral medication of its kind, Cipro, or by its generic name, ciprofloxacin, belongs to a class of drugs known as fluoroquinolone antibiotics. Fluoroquinolones (FQs) are particularly potent drugs that are used to treat many different types of infections. However, they are also known for causing debilitating, long-lasting side effects. Despite this alarming fact, fluoroquinolones are one of the most commonly prescribed drugs in America.
A NATION IN PANIC
On September 18th, 2001, just a week after the terrorist attacks on the World Trade Center, five envelopes containing a strange granular substance were mailed to each major news source in America. One month later, an employee at American Media, Inc. died of inhalation anthrax, a rare but serious bacterial infection in the lungs. His death was closely followed by the discovery of more letters contaminated with what was determined to be a potent strain of anthrax spores. The nation, still reeling from 9/11, went into hysteria. Over the course of the months that followed, a total of five people died and many more were afflicted with anthrax in a mysterious case of bioterrorism committed against American civilians.
When the United States Centers for Disease Control (CDC) recommended Cipro as a preventative measure for anthrax exposure, I was concerned. I had spent two years collecting data, writing and rewriting, and then shepherding my article, “Peripheral Neuropathy Associated with Fluoroquinolone Antibiotics,” toward publication. It wasn’t easy. Several of the peer reviewers didn’t like what I was saying in the article and tried to block its approval.
Fortunately, the publisher stood firm and set the date for publication to December 2001. After the anthrax scare in October, the publisher and I felt the information was urgently needed when Cipro became a household name and people began taking or hoarding it without medical basis. Cipro’s downsides weren’t widely known then, even among doctors. Yet, many of the forty-five subjects of my study were injured or disabled years after taking Cipro, suffering from neurological, musculoskeletal, psychiatric, and cardiac reactions to the drug.
THE PRESS RELEASE
The press release accompanying my article, “Peripheral Neuropathy Associated with Fluoroquinolone Antibiotics,” appeared on October 22, 2001:
Adverse effects associated with the use of ciprofloxacin (Cipro) and other fluoroquinolone antibiotics are not always benign. Not infrequently, they can be severe and permanently disabling, and they may occur following just one or a few doses, according to a study posted on The Annals of Pharmacotherapy Web site today.
The article described forty-five cases of FQ toxicity involving the peripheral nervous system, such as tingling, numbness, weakness, burning pain, twitching, or spasms. In addition, 93 percent of the subjects sustained adverse side effects involving other systems: 78 percent experienced central nervous system (CNS) symptoms such as dizziness, agitation, impaired cognitive function, intractable insomnia, or hallucinations; and 73 percent reported musculoskeletal symptoms such as joint or muscle pain or tendon rupture. In many cases, toxicities also involved the cardiovascular and gastrointestinal systems, skin, and sight or hearing.
The age of subjects in my survey ranged between eleven to sixty-eight years old, with an average age of forty-two. The great majority of the cases of FQ toxicity were severe, lasting three months in 71 percent and exceeding one year in 58 percent of cases. In 62 percent of these cases, subjects had no other medical disorder except an infection (sinusitis, prostatitis, or urinary infection) that led to FQ treatment. In other words, these people were mostly young, healthy individuals— until FQ therapy.
The media jumped on my article and wrote about it in newspapers and magazines. My telephone rang a lot. I spent a few minutes on NPR’s Morning Edition with Bob Edwards. Within days, the CDC announced it was dropping Cipro as the favored antibiotic for anthrax exposure and now recommended much safer antibiotics, such as doxycycline.
ANTHRAX OR CIPRO?
I wish I could say that was the end of it, but it was just the beginning. Six months later the Washington Post carried a story, “Anthrax Patients’ Ailments Linger.” The story described symptoms such as fatigue, exhaustion, joint pain, and memory problems lingering in some postal workers. The article pointed its finger at anthrax exposure, but I suspected many of the cases were from Cipro toxicity.
Five days later, the United Press International posted “Anthrax Ills Mirror Cipro Side Effects” on its website:
Doctors treating several survivors of last year’s anthrax attacks describe a continuing set of symptoms that are similar to reported side effects of the main drug used to treat them. Side effects include joint pain, fatigue, confusion, difficulty concentrating, and memory loss.
“They all fit, right down the line,” said Dr. Jay S. Cohen. He said Cipro and other fluoroquinolone antibiotics are well-documented as sometimes causing psychiatric and neurological side effects, as well as musculoskeletal problems. Doctors following these cases do not know whether the problems suffered by the handful of anthrax survivors are related to Cipro or from anthrax.
“It is an interesting possibility,” said Dr. Mark Galbraith, an infectious disease specialist in Virginia who is treating one survivor. He discontinued Cipro for his fifty-nine year old patient after two weeks because of a rash and painful joints. Months later, joint pain and difficulty persist. The CDC acknowledged that a percentage of patients did not continue their Cipro because of side effects including joint pain, dizziness, nausea, fatigue, or diarrhea.
“A lot of people did stop taking it,” said American Postal Workers Union spokeswoman Sally Daridow. The organization has asked Congress to investigate how Cipro and other antibiotics might affect workers long-term. Congress never did, so in 2004 I sent a letter to Congressman Rush Holt of New Jersey, asking for an investigation. Nothing materialized.
In December 2001, the American Spectator published the following in Ben Stein’s Diary:
We [Stein and another person] talked for a long time about the anthrax threat in D.C. and then about the medicine of choice, Cipro, that’s being prescribed for it. Just by fate, I had been given Cipro a few weeks before and had suffered simply horrible, dreadful, unbelievably bad psychological side effects: dread, suicidal thinking, panic. In fact, I had the first real panic attacks I had endured since I stopped taking benzodiazepines about twelve years before. I had been mystified about what was causing them until I looked up Cipro in the paperback edition of the Physicians’ Desk Reference, only to find that high among the list of side effects are “abnormal fear” and “dread.” My doctor pooh-poohed these effects, but when I stopped taking the Cipro, the effects disappeared pronto.
The suddenness of Stein’s reaction and its severity are typical of many accounts of FQ toxicity. In my study, 58 percent of patients developed reactions within three days of starting a FQ. Also, 70 percent had symptoms like Stein’s involving the central nervous system, such as severe agitation, panic, impaired thinking, hallucinations, suicidal ideation, insomnia, and “brain fog.” Typically, Stein’s doctor dismissed the reaction, although there were no other credible explanations for his symptoms. His doctor’s ignorance wasn’t anything unusual, either. At the same time, the health editor of a national magazine wrote that a thirty-day course of ciprofloxacin “wouldn’t cause a healthy adult much harm.”
Fortunately, Stein’s toxic reaction cleared quickly. He was one of the lucky ones.
THOUSANDS SEEKING HELP
After publishing “Peripheral Neuropathy Associated with Fluoroquinolone Antibiotics,” I began to receive letters and emails. This one arrived a few months later, in early 2002, from a bioengineer at a local biotech company:
I am a thirty year old female with no medical problems before I was given Cipro for a suspected urinary tract infection in March 2002, though my culture came back clean later. I took Cipro for only three days and have been having muscle, tendon, and joint pain since. I was so devastated last week while reading emails from an adverse drug reactions forum, since most of them are saying that the symptoms would go on for years and years. I almost cried on the way home from work as I was driving by the beach and worrying I might never be able to run along the shore again. What’s troublesome about this whole situation is the lack of awareness of the doctor about this problem. Like many cases in your paper, my doctor too dismissed the idea that my symptoms have anything to do with Cipro and no one warned me of anything before I took it. I do wish that, one day down the road, people could at least get a warning from their doctors before they took the medicine.
I felt badly because I had little help to offer her. Today I could offer many suggestions, although still there is no well-proven remedy.
“At least you listen to me,” she said to me, “At least you believe me. You understand the harm these drugs can do.”
THE PROBLEM WITH FLUOROQUINOLONES
Since 2001, I have consulted with people from the United States and Canada who’ve been “floxed,” the term used by people badly injured by FQs, although we rightly could use the word “poisoned.” Over the last fifteen years, I have spoken with approximately 500 such people who’ve become seriously injured—often times to the point of disability—after using FQs.
“Only 500 cases—what’s the big fuss, Cohen?” you might ask. The number today is about 50,000 cases reported to the FDA, and according to RxISK.org, 79,000 reports and 1,700 deaths with Cipro alone, and the FDA’s number may likely be ten or twenty times higher. This is the definition of an epidemic, and it is wholly man-made.
The problem is, it is unlikely you’d ever get an accurate description of FQ’s toxicities from most doctors. Studies show that only 10 to 25 percent of patients receive adequate warnings from their doctors about the drugs they are prescribed. This means that 75 to 90 percent do not. And if many doctors are unaware of the extent and severity of FQ reactions, how could they provide you with an adequate warning in the first place?
It is not an exaggeration for me to say that the development of penicillin and subsequent antibiotics are among the top achievements in the history of medicine. Because of these wonder drugs, the top causes of death in the early twentieth century, pneumonia and tuberculosis, are no longer feared. Drugs can perform miracles, and I prescribe them every day in my practice. Yet with all due respect to the good things FQs accomplish—they can indeed be life-saving—the number and severity of FQ toxicities are unacceptable.
WHAT’S IN THIS BOOK
Part 1 of this book, “The Problem,” will introduce you to fluoroquinolones and their potential for destruction. Chapter 1 addresses the issue at hand: fluoroquinolone antibiotics are commonly prescribed but hazardous drugs. You will learn how and why doctors seem to have overlooked the dangers of these popular drugs for almost thirty years. Chapters 2 through 4 discuss how fluoroquinolone toxicity syndrome affects the tendons, joints, and bones; the central and peripheral nervous systems; and other parts of the body, including the heart, gut, and brain. Finally, Chapter 5 will explain how quinolones are damaging to DNA.
The second part of this book, “What We Must Do Now,” starts by explaining the various kinds of medications, supplements, and other treatments that can be used to fight fluoroquinolone toxicity syndrome. Chapter 8 discusses at length how the mineral magnesium does wonders for treating FTS and includes a guide to using magnesium to treat toxicity symptoms. Chapter 9 focuses on three other types of medications—N-acetylcysteine, zinc, and vitamin E—which have been scientifically proven to combat FTS. Chapter 10 lists a number of treatments that many sufferers of FTS have used to treat their symptoms. The final chapter in the book outlines the action steps I have devised in order to stop fluoroquinolone toxicity and gives pointers on what we can do going forward.
This book is not about bad drugs that must be banned. It is about good drugs that have saved hundreds of thousands of people, but have also severely injured tens of thousands of others, sometimes permanently. Doctors remain poorly informed, dismissing people who have become seriously injured after taking fluoroquinolones. Currently there are no scientifically proven treatments for what I call fluoroquinolone toxicity syndrome, or FTS. My goal in writing this book is to shed much-needed light on a terrible medical problem that persists today, and to also encourage efforts toward finding more effective solutions.
The FQ tragedy ranks among the worst in history of modern medicine in terms of numbers, pain, and disability. Unfortunately, the tragedy will continue until appropriate FQ use is clearly defined and limited to serious or life-threatening medical disorders by the drug companies and FDA; patients are fully informed about the possible toxicities of FQs before they are prescribed them by their doctors; doctors prescribe FQs only when there is a legitimate, proven reason for their use; and doctors correctly identify FTS reactions and report them to the FDA. The poisoning of healthy people by FQs has to stop. And we can start accomplishing this now.