“Death by Levaquin” Brain/Body Toxic Drug

Here is a video that Bob G and I were in about fluoroquinolones. Ivanhoe produced this short news story.  The producer of this story told Bob and I that it will eventually be going out to over two hundred news stations across the country. After speaking to Mr. John Cherry, he has told me it would be fine to put this story on this blog.  

 http://ivanhoe.com/viewers/watch_video.cfm?vid=MB2979&title=The%20Safety%20Gap:%20Money,%20Medicine%20and%20You

I was disappointed with a few items in this story. First, they should have mentioned Cipro for Bob’s problems and that Cipro is also a fluoroquinolone that has a “black box” warning along with Levaquin.

 Secondly, I thought it was very irresponsible to have Tim Wells on this news piece saying that you don’t have to worry about reading drug labels. That the drugs on the market are safe. That was a very reckless statement by Tim Wells, former FDA employee. Drug labels should always be read. 

At least with this news story going out to a lot of news stations across the country it will help to spread the word on the dangers of fluoroquinolones. I will see if I can get Ivanhoe to do a follow-up story specifically on fluoroquinolones. Maybe they can get a victim or two from Cipro, Levaquin,  Avelox, or any other fluoroquinolone. Even though I didn’t agree with having Tim Wells in this news story I do very much appreciate Ivanhoe doing a story on this subject to help inform people about the dangers of these antibiotics. Cyndy Donaldson, from Ivanhoe, spent a lot of time with Bob G and I for this piece and she was really supportive of our cause and was great to work with. Many thanks to her, Mr. John Cherry, and Melissa Medley.      

I am going to try and write a Citizen’s petition against the FDA for stricter warnings for fluoroquinolone antibiotics. I am not really sure how to go about this. I posted a link below that explains most of this process. I  googled “How to do a citizen’s petition to the FDA” and the link below came up. A couple of fluoroquinolone victims in the state of Illinois were successful in petitioning the FDA for tendon warnings. They were able to get the Attorney General in their state to issue the petition and get the Public Citizen organization to join them in the petition against the FDA. 

There are two important issues that I think should be addressed in a petition for fluoroquinolones:

 The “black box” warning that has already been issued is good but still not adequate because the warning is only on the package insert at the pharmacy and not on the prescribing literature that people get when they pick up their prescription. Since nobody receives the package insert nobody really knows that there is a “black box” warning for these antibiotics. People deserve the right of informed consent before taking something as dangerous as a fluoroquinolone. A petition to the FDA needs to be made to have the “black box” warning for fluoroquinolones be put on the prescribing literature that people receive when they get their prescription. People should have the right to make their own decision based on adequate information on the benefits and risks of fluoroquinolones.

The second warning that needs to be placed on fluoroquinolones is for a “black box” warning to be issued for central nervous system damage that can result from these antibiotics. A “black box” warning needs to be issued on the prescribing literature for prolonged or long term insomnia, anxiety, mood changes, panic attacks. I am not sure of what the correct wording for this should be. I will have to think about exactly how this should be stated and then post this on a later blog. I actually think that the incidence of central nervous system damage is higher than the incidence of tendon disorders. That is just my opinion though.

I will have to contact the Pennsylvania Attorney General’s office to try and get them to issue a “black box” warning. I think it will be easier if I write the petition and just try and get the Attorney General’s office approve it. Their staff people are so busy that if I can do the leg workfor this maybe there will be a better chance of them going along with it. Maybe I should also try and call Public Citizen to see if they will join in the petition. I will have to show the Pennsylvania Attorney General’s office the petition from the Illinois Attorney General’s office so that there is a higher likelihood of them going along with this. I need to think this whole thing through so that I do this in the best manner. I know some floxed people here in Pennsylvania and maybe I can get them to join in this effort. Unfortunately my dad has been having leg pain and weakness for about a month or two so I am helping my mother care for him. This is taking time away from some of my advocacy efforts. Plus my own illness from the Levaquin poisoning is taking lots of time up.   

http://www.fda.gov/ora/fed_state/Small_business/sb_guide/petit.html

I sent the letter listed below to Dr. Graham who works at the FDA. He is one of the few at the FDA that actually has a conscious. He was bullied and pressured by other high ranking members of the FDA to not come forth with his findings about Vioxx. He was also instrumental in helping to get Omniflox, a quinolone antibiotic, off the market as well. Hopefully he can give us some direction in trying to get the Black Box warning on the literature at the pharmacy that people get with their prescription for Levaquin, Cipro, and Avelox. I would be willing to bet that 99% of us who have been poisoned by a quinolone after the Black Box warning came out last July were never told that there was a Black Box warning for these antibiotics. Our doctors didn’t tell us nor was there any warning at the pharmacy in the prescribing literature. That is criminal! 

Dear Dr. Graham,

I want to thank you for all of the great work that you have done at the FDA. I am very sorry to learn that you were harrassed and pressured to not come forth with your findings about Vioxx. As you know, you saved thousands of future lives in doing so. I believe you were instrumental in getting Omniflox off the market as well.

I know you are very busy so I don’t want to take up too much of your time. I just wanted to see if there is a way to make people aware of the Black Box warning for fluoroquinolones. The vast majority of doctors don’t provide this warning to their patients. More importantly is that there is no mention of a Black Box warning on the literature people receive at the pharmacy for fluoroquinolones. The Black Box warning is only on the package insert at the pharmacy. Nobody reads the package insert. I believe that the right of informed consent supersedes any other right. People should have the right to read that there is a Black Box warning in the prescribing literature that they receive at the pharmacy. I think it is criminal that people are denied this right.

I have been disabled for almost four years from taking Levaquin. I have brain damage and damage to my nerves and tendons. Ironically, I was a pharmaceutical sales rep that actually sold a drug that contained Levaquin – Quixin.

I was wondering if there was any way to mandate that the Black Box warning be put in the prescribing literature? I emailed you an article I wrote for my hometown newspaper on the dangers of fluoroquinolones.  Thank you very much for all of your time and consideration. It is very much appreciated. Keep up all the great work at the FDA.

Here is a Dear Doctor letter from a doctor who has been poisoned from Levaquin for several years. Noted in the letter is that the incidence of these reactions is much higher than previously reported. Does anybody honestly believe that quinolone manufacturers are stating the truth about the incidence of side effects? I posted about a week ago a story from Readers Digest about how Sanofi actually made up the safety data concerning Ketek antibiotic. Yes, that’s right, the data was forged. The story was in Readers Digest. It is reposted in my blog. And what did the FDA do regarding this? They helped conceal the data. Our government agency, the FDA is helping to protect the financial interests of the pharma companies at the expense of the individual.  Please read the letter from Dr. Plumb below.

http://www.fqhelp.com/sites/default/files/Todd%20Plumb%20Dear%20Doctor.pdf

I called the FDA today: 1-888-463-6332. I asked about the Black Box warning for quinolones. I told the lady at the FDA that the Black Box warning was issued over 6 months ago. I asked when will it be put on the prescribing literature at the pharmacy. I said it was outrageous that it has taken so long and there is still no Black Box warning yet. She actually agreed with me that this is an outrage. The FDA is agreeing with me that this is an outrage. Wow! She told me the reason why the Black Box warning isn’t out on the prescribing literature is that congress hasn’t given the FDA juristiction to regulate the content of the prescribing literature at the pharmacy. She said that the Black Box warning is on the Package insert only. The package insert is the tiny little fold out that is attached to the Levaquin or Cipro medicine bottle in the pharmacy. Each medicine bottle in the pharmacy has a package insert attached to it. This package insert is not given to patients. Many people don’t even know that there is a package insert. Patients never get the package insert. The prescribing literature is what is only given to the patients. So in effect, patients never recieve the Black Box warning. This is unbelievable! A Black Box warning was issued over six months ago for quinolones and it will never reach anyone at pharmacy when they pick up their prescription for Levaquin, Cipro or Avelox. This is terrible. If anyone would like to call the FDA at the number above to express their outrage at this please do so.

Went to the pharmacy today to pick up my pain medication for the Levaquin poisoning. I asked the pharmacist if the “Black Box” warning is on the pharmacy literature for Levaquin. He read the Levaquin literature and told me that there was no  ”Black Box” warning on it. No ”Black Box” warning yet?  What the heck is going on?  That warning was issued back in the summer of 2008. It has been approximately seven months since that warning was issued. It doesn’t take seven months to put that warning in the prescribing literature at the pharmacy level. It is really amazing just how crooked the FDA and the quinolone manufacturers are. More and more people are being poisoned. Every patient deserves the right to know that there is a “Black Box” warning on these antibiotics.

In addition to this, most physicians do not warn patients about this risk. My aunt, who is in a nursing home, was just given a prescription for Cipro even though it is flagged in her chart for no quinolone antibiotics. Thankfully she knew enough to ask for a different antibiotic. She is also asking to have a different doctor after such a basic error. When I was at a Urologist’s office a couple months ago the Urologist told me that he still prescribes a ton of Cipro . That was his exact phrasing- a ton of Cipro. He told me this even after I told him I have Levaquin induced brain damage and damage to my tendons and nerves for the last three years. Unbelievable!  Some of them either don’t have a conscious or they are living in a world of denial and allegiance to the drug manufacturers.

When will the “Black Box” warning be issued to the pharmacies? That is what I would like to know. Maybe I will call the FDA and listen to their BS excuse.  This is criminal the public is denied this proper warning. There is only one reason why this situation exists. It is because the drug companies will make more profit by not having this warning label on the literature at the pharmacies. They don’t want the public to be concerned with tendon ruptures or tendon pain. It’s that simple. The motive is profit as it always has been.

Please educate others on the crippling side effects of Levaquin, Cipro, and Avelox. The side effects can last years or are often permanent.

Went to the Urologist for a checkup. I now have some sort of hard pea sized lump on my testicle. Urologist didn’t know what it was. Said it could be a cyst. Had an ultrasound done and the Urologist said it looks like a precancerous condition. He said I should have an ultrasound done every 3 months now. He mentioned there are vertical ridges on the ultrasound report. I’m sure it’s Levaquin poisoning doing its work. Probably like the ridges on my thumb nails. My thumb nails look like they have aged 50 years with deep groove like ridges on them.  Just like on T. Boomer’s flox report.  Talked to another quinolone victim who told me quinolones can cause cancer. There is no history of any type of cancer in my family either. There aren’t too many adverse health conditions left that Levaquin hasn’t caused me.

In between patients I heard the Urologist call a script in for Levaquin for a patient. During my appointment I pulled out a sheet I printed up from Injuryboard.com  that had Levaquin and Cipro along with a big bold face Black Box warning. I asked him if he knew about the Black Box warning. He said yeah but that is mostly older people. I told him that Dr. Cohen says it is mostly the young, healthy, and active people that are crippled from this. I could tell he didn’t believe me. I still can’t believe he would prescribe this after I told him I have brain damage and damage to my tendons and nerves for over 3 years now. It was like he didn’t even really care. I really felt offended by his lack of empathy. After I left, I taped the black box warning on a wall outside his office in the medical building. I then hobbled over to Kinko’s and photocopied a bunch more of the black box warnings for Levaquin and Cipro and the information sheet from Antibiotics.org. I taped another black box warning photocopy and Antibiotics.org photocopy in that same medical center and shuffled over to another medical complex and taped up the black box warnings for patients to read. If doctors aren’t going to give their patients informed consent on these poisons then I feel I need to take some sort of action. I wonder how long it will take before these are torn down.  I think I am going to try hitting more medical complexes, hospitals and offices with these warnings.

There has been some speculation that olympic volleyball gold medalist Misty May Treanor’s torn achilles tendon is due from taking an antibiotic. Right now this is only speculation. It had been mentioned that she had possibly taken an antibiotic for an upper respiratory infection. If this did happen to be the result from an antibiotic I have no doubt that it is from a quinolone. I have never heard of another class of antibiotic causing this type of injury. Plus, the recent “black box” warning on quinolones for tendon rupture would make it even more logical.

Many years ago there was a very young and talented baseball pitcher for the Chicago Cubs who had damaged his throwing arm. He was so good that he was awarded the Cy young award for the best pitcher in the national league. Unfortunately, his name escapes me. The story goes that he had severely damaged some tendons in his throwing arm from being prescribed a quinolone antibiotic. The manufacturer quickly flew a couple of lawyers out to meet with him. He signed an agreement for a few million dollars in exchange for his silence about the damage being caused from the antibiotic. When a celebrity gets victimized by these antibiotics the last thing in the world the manufacturer wants in bad publicity. If a celebrity screams foul and warns the masses about an antibiotic causing severe injuries you can bet much of the world will listen and take notice. This young pitcher went from being a Cy Young award winner to his career being over in a short time period. The drug companies will simply do anything to keep quinolone toxicity from being known to the masses.

Ortho-McNeil, the manufacturer of Levaquin, even flew a few executives out to see a doctor in Utah to try and keep him from warning his fellow doctor friends about the damage from Levaquin. This doctor is still suffering from Levaquin toxicity two years after his last pill.  This doctor was simply telling his Levaquin story to other physicians and those physicians then started to prescribe less Levaquin. The doctor that is damaged from Levaquin said that the executives were not really even concerned about his injuries. They were just concerned about trying to supress any grass roots movement about Levaquin toxicity from being known to the public and to also disuade him from telling his physician friends. His name was even being brought up at district sales meetings in an effort to figure out what to do to about him.  It’s all about the money. Ortho-McNeil is a public company. And like any other public company they will do whatever they can to maximize shareholder wealth. It doesn’t matter that lives have been ruined. It matters only that the stock price is maximized.

Please warn and educate others about the crippling injuries caused by Levaquin and other quinolone antibiotics.    

Today is September 20th, 2008. A Black Box warning was issued for Levaquin and other quinolone antibiotics many months ago. This is a very strict warning for this class of antibiotics. It has been over 3 months now since this warning has been issued. I have a friend who took 5 pills of Levaquin and has been on crutches every day of her life for over 10 years. She is disabled and on narcotics every day since her reaction. She works 4 hours a week in a pharmacy and is very committed to trying to bring change to this terrible destruction of innocent lives from these crippling antibiotics. She called me today and said there has been no update to the package insert for this class of antibiotics. Months after this warning was issued there is still no Black Box warning on the package inserts or the prescribing literature that is given out at the pharmacies. She told me that the manufactures of these drugs are required to have these updates on the warning labels within 60 days. It has been over 60 days now. Once again, the drug companies and the FDA have colluded to keep this toxicity hidden from the public. There has also not been any “Dear Doctor” letters sent out informing physicians of this Black Box warning.

When I went to my doctor and told her about the Black Box warning she said the Levaquin sales rep told her that this warning has been out for many years now and that this is nothing new. The Black Box warning was no new information to doctors so it is nothing to be concerned about. My doctor looked at me like I was trying to sensationalize this issue. It is unbelievable how the Levaquin sales reps are spinning this issue to downplay concerns. Simply unbelievable! When I was a healthy pharma rep I was trained on how to sidestep and downplay concerns and then quickly move on to show the benefits of the drug I was selling. Pharma sales reps are only concerned about sales. Most of them never provide full disclosure on side effects since they will earn a large bonus if they can maximize their sales. It’s a scary world when doctors rely on pharma reps for the majority of their information on drugs. They never open up the PDR or the package insert for more accurate unbiased information. You need to be your own advocate in today’s world. Simply too much corruption. 

It took decades for this warning to finally appear on the quinolones. The warning label is a Black Box warning on Quinolones for tendon pain and tendon rupture. I wish they would have added one for all of the neurological adverse effects. I think these side effects outnumber all of the tendon disorders. Hopefully future warnings will appear about the devastating central nervous system effects.