FDA evaluates popular antibiotic that patients say makes them sicker
KANSAS CITY, MO (KCTV) –
It is an antibiotic powerful enough to kill anthrax or the plague, but it is being prescribed for simple infections like sinusitis and urinary tract infections.
One group wants the Food and Drug Administration to reach beyond a black box warning issued in 2008 for Levaquin after an internal FDA report showed possible links between the drug and debilitating diseases like ALS, Alzheimer’s and Parkinson’s.
“We’re talking about a possible drain on future healthcare costs,” Linda Martin, of Arizona, told KCTV5 News in a phone interview.
Martin took Levaquin three times for sinus infections. She is now an outspoken critic of the drug, helping file a citizen petition last year calling for better labeling by the FDA. Click here to read the petition.
Levaquin is an antibiotic known as a “quinolone” or “fluoroquinolone.” Other brand names include Cipro, Avelox and Levofloaxcin.
“It’s a good antibiotic for infections in many different organ systems in many parts of the body, so it’s very widely used over the last 20 years,” said chief medical officer Dr. Lee Norman at the University of Kansas Hospital.
The FDA issued a black box warning in 2008, a serious red flag meant for doctors to note before prescribing quinolones to their patients. The warning came after the FDA discovered Levaquin to cause tendonitis and tendon tears.
But people like Chris Butler of Raymore say their doctor doled out the medicine three to four times a year for sinus infections well after the black box warning surfaced.
“It makes me angry. It is hard for me to even express just how angry I am. Because I feel doctors, pharmacists, medical practitioners should know about black box warning on drugs,” Butler said.
Butler underwent four tendon tear surgeries and started experiencing neurological disorders before he launched his own investigation into Levaquin. It wasn’t until 10 years after his first Levaquin prescription, he figured out, he had been taking a drug known to cause such injuries.
In 2013, the FDA started warning users of peripheral neuropathy, neurological diseases that can lead to tingling and pain in the limbs. Butler also knows those symptoms well.
“Even to this day I will have shooting pains in my hands and my feet. My hands will go numb, my feet will go numb,” Butler said.
But what hasn’t been disclosed is a condition called “mitochondrial toxicity” detailed in the 2013 internal FDA report. It is a condition that can lead to lasting neurodegenerative diseases.
“Mitochondria are the little organs inside each cell that are basically power plants that generates the cell,” Norman said.
Research in non-human mammals showed quinolones can cause the weakening of those cells.
Martin and the citizen petition wants these possible serious side effects to be on all warning labels for antibiotics like Levaquin.
The FDA told KCTV5 it is not ready to respond to the request.
The group has also shared the information with lawmakers on the U.S. Senate Health Committee which includes Kansas Sen. Pat Roberts. He did not return our messages for comment.
“I trusted my doctors to do what’s best for me. And when I realize when I couldn’t trust them to warn me about the drugs, it was my responsibility,” Butler said.
Butler is not taking legal action against his doctors or the drug company. He says his sole purpose in speaking out is to raise awareness about taking prescription pills like Levaquin.
“It’s being used for things like sinus infections. For women, UTI’s is this drug appropriate for those situations?” Butler asked.
Norman doesn’t believe quinolones should be taken off the market. He says these kinds of antibiotics save lives but consumers need to ask more questions and do research before popping a pill.
“Does every doctor know about every single product and every line of the package insert? No. I can assure you, no,” Norman said, “I really think it’s important people ask questions.”
Filed under: General Problems
In respect to all patients and the Medical System. I have been harmed by this class of Antibiotics, Fluoroquinolones. In my records I am sure I have taken it at least three times. I started having trouble and complaining to the Drs. No one ever tried to get to the root of the problem, they never even looked. I was handed a new RX at every visit, and let me say my sinus infection was never cultured. I undeestand how difficult it is to maintain knowledge on all these medications. Through all this I searched for answers myself. I never dreamed it was a Antibiotic, but when reality came crashing down and I did realize what had caused all problems I was having. The Medical System dismissed anything I said. Now I was not trained in the Medical profession. However I do know my own body. And something went terribly wrong. It built up and exploded. I have learned the hard way to make sure I manage my own health care and to be knowledgeable. When a Dr is ready to hand you a RX within the 5 or so minutes they have spent with you it becomes a little scary. This system is broken by all standards. Patient care needs to be re- evaluated, Value being the key word here. It has some how been lost along the way. The assembly line care people receive is dangerous.
Thanks for sharing. I was also poisoned by a drug in this class. It happened Jan. 25, 2016, and I still struggle with the effects.
Thank you for the reporting on this important health issue affecting many individuals worldwide. This class of antibiotics has many known but under recognized serious side effects that are disabling patients. I was prescribed Levofloxacin without any warning of the serious side effects, because my doctors were not aware themselves. When I called on day three to report that something was going wrong I was told to continue my prescription. After 9 pills I was disabled. For 2 + years, walking only with crutches, hearing loss, vision affected, crushing fatigue and neuropathy. My doctors attribute all of my symptoms to Levofloxacin and were devastated that they had no treatment for me. They have changed their practice. Advocating for greater awareness is essential both for medical professionals and for patients. Thank you again.
Please start educating the health care industry. I was given ciprofloxacin for a bronchial infection, without any culture being performed. On the fifth day, severe anaphylaxis hit. I almost died. Doctors are told the adverse reactions are rare. In the three years since, my body has continued to deteriorate. The knowledge is there. The studies are there. I do not understand how, with increased warnings, the medical field is not being further educated as to how seriously these “antibiotics” (chemo drugs) can permanently alter cells. They are given to patients improperly. It’s abhorrent, and life altering. In that same three years, one support group has gone from ~350 members to over 7000. That’s not rare. I fear most are walking around, ignorant of the cause, suffering from a host of misdiagnosed autoimmune disorders.
This is one of those situations where the various parties have an ethical and moral obligation to share responsibility. This includes the end user. As a society we’ve become complacent and stopped taking any responsibility for our actions. On one hand, we have this State-created Expertocracy that is supposed to know all and see all within the scope of their art. Good luck with that. Even with the all the “automated” information sources out there, it’s impossible to issue the most important advisories 100% percent of the time to 100% of the people who need this information the most. So what’s the solution.
Back in days past, in a time only dimly illuminated in the annals of history, there was a quality that was held as most laudable and meritorious in our society. It was called “Personal Responsibility”. Yes, i know that is a profane pronouncement to some. Isn’t that what the government is supposed to do? Isn’t the State Almighty supposed to wipe our noses and butts from cradle to grave? Yeah, hows that working out for us. With the internet and resources like Web MD, there is no reason that the majority of people cannot engage in a little self-education before they swallow the encapsulated or tableted dose of whatever concoction the prescribing care provider has directed the pharmacy to prepare for the individual. Is it that the average John and Jane Sixpak are too busy to do a little research? Perhaps it’s apathy. Then again it could be an ill placed level of confidence in one or two fallible human beings who are doing their best to treat the ill in a system that places the Almighty Dollar above such paltry human concerns like iatrogeny, aka unintentional medical misadventure resulting in patient harm.
That same misplaced faith ultimately is placed in an alphabet soup of State bureaucracies that pronounce noble statements like, ” We are here to protect you from . Regulation is the result of the average individual abrogating their personal responsibility and yet, situations like the Fluoroquinolones still can cause significant harm. Are more regulations the answer? I think not.
There is indeed a dependency problem in our land. It’s not prescription opiates or or street drugs. it’s an addiction that has many individuals in it’s grip. It is the dependence on the Panacea of the ficticious totally reliable government. It’s a lie. We’re promised this panacea in exchange for a measure of our individual, protected liberties. Every time there is an issue, real or manufactured, we’re told for just a little bit more of our freedom that we surrender to the State, we will be given greater security and less to worry about. This is a lie that is as old as civilization.
As to the topic of individual prescription drug education, perhaps this little gem will will motivate the reader to assume some personal responsibility. When I was in pharmacy school, one of the first lectures I attended started with this introduction: “All drugs are poisons. Every last one of them. The only difference between even lowly Aspirin and Strychnine is a matter of what constitutes a lethal dose and the effects from the toxicity. At relatively low doses, the toxic effects of Aspirin can be harnessed with a medicinal benefit. Those poisons that have been discovered to have medically beneficial “toxic effects” are called drugs and the beneficial “toxic effects’ are termed therapeutic effects.”
These drugs are dangerous and should be reserved for life and death situations. I enjoyed my career in the medical field and am now disabled due to taking generic Levaquin. The FDA is supposed to protect us and that means putting all the warnings on the medication. We need to be informed!;
I’m sorry for your suffering. Thank you for the info. I’ve had this drug when I had acute pancreatitis & was in the hospital (after a procedure known as an ERCP…) now… who knew I’d be one of the 3% of people to get this very serious reaction from the procedure… (I went to a different GI after this who performed the same ERCP procedure TWICE after this experience, only to be hospitalized twice more for pancreatitis–)some doctors are very unsafe, my health was precarious and fragile, somehow I STILL trusted he knew what he was doing, each time that’s what he said…. he was VERY experienced….. should have just stayed with the 1st doc, who I’m sure was not going to repeat this! (He actually got mad at ME! I think he was embarrassed for his reputation…) nothing to do now except pass info along…. (still having health issues unfortunately, but hope to get better and better…. (my new primary just took me off oxycodone with all this hype/legislation, not sure what I’m going to do… my wonderful pharmacist actually got involved on my behalf, asking her not to just cut me off like this, my health being in a fragile state, withdrawal will be hard on me, and I’m hoping I won’t end up in the scary hospital! I am now very frightened of this medico-political-industrial-complex!!!!