Did You Break a Nail? Oh My. Here is an SSRI Drug For You!

Posted on November 10, 2014 by Angela A Stanton, Ph.D.

No I am not joking; I wish I were. Today SSRIs (Selective Serotonin Reuptake Inhibitors) are used for just about everything: ADD, ADHD, Menopause, Pain, Migraine, Fibromyalgia, depression, insomnia, OCD, sexual dysfunction, and the list goes on. It is as if we hit the jackpot and found a miracle cure for every ailment possible!

I wrote on this blog several times about SSRIs before. One article is about how it is used for migraine and why it is so dangerous, so you should read that article for refresher but I explain here what it is and what it is not a bit more in detail from a different angle. I am using here the same drawing though that I drew before to show how SSRI works.

This image is taken from the previous article that I drew in a highly simplified form. The goal of SSRI is to induce the neurons that manufacture serotonin neurotransmitters to produce more endlessly. The “reuptake” is a sensor that would allow the neuron to know how much serotonin it already made and once the serotonin level reaches the reuptake, it would send message to the neuron that there is enough; it would inhibit the neuron from making more. SSRIs plug the reuptake by something that is not serotonin so the neuron has no clue that it has made a ton of it already. It just keeps on producing it. There are many problems with this that is explained in the previous article.

One of the things that got me really upset was while watching TV tonight there was an advertisement  for a menopausal drug that was saying that it helps with hot-flashes. This would have been fine but then they said the following: “in a non-hormonal way.” This made me pop off the sofa to see what exactly this magical non-hormonal drug was that takes away hot-flashes! Based on the list of adverse effects warning, I knew immediately that it was some kind of serotonin but not sure yet what  kind. As it turns out it is not estrogen hormone alright but it is a hormone! It is serotonin hormone.

You see, while serotonin is in the body, we call it hormone. When it is in the brain, we call it neurotransmitter. They are exactly the same chemical elements only their functions change based on their location. They are definitely hormones though. There is a  trick about SSRI and while the TV ad could have said it is “not a hormone,” by saying it is “not hormonal” it lied. While it is not hormone itself, its job is to create extra hormone. It is like me telling you that I am not selling my house; my real estate agent does. The fact is I will end up with a sold house and in the case of SSRI I will end up with a ton of hormones I did not have before. So is it hormonal? You bet it is! And it is a dangerous one at that.

But let me ask you this: Given the many illnesses SSRIs claim to be able to treat today, would we not all be healthy by now? How come people end up with suicidal thoughts, kill themselves, end up with headaches, serotonin syndrome (toxicity), and develop additional illnesses all the time? And what exactly are we going to do with all the serotonin we manufacture as a result of SSRIs that are so good for us. One of the side effects of too much serotonin in the brain is serotonin syndrome. In the 2012 Annual Report of the American Association of Poison Control Centers’ national Poison Data System (NPDS): 30th Annual Report you can see all drugs that poisoned people for whatever reason and how many died. In this report there were 47,115 serotonin syndrome cases reported and 89 people died. This is reported by the 15% of doctors who actually recognize a serotonin syndrome when they see one. Doctors don’t seem to be aware of the phenomenon of serotonin syndrome. If we add the 85% of cases that were missed by doctors, we are talking about an epidemic.

It is an epidemic because while doctors prescribe SSRIs left and right for just about everything, they can not diagnose an overdose. Why are they not cognizant of the overdose? It is possible to get a serotonin toxic level buildup from a single SSRI tablet! And why are they so prescription happy of SSRIs the first place? Why is this generation so lacking of serotonin that we must force the brain to make more? Are we doing something to take all of the neurons that normally make serotonin in our brains and bodies and tearing them out?

Actually we are doing some things that indeed may reduce serotonin in our brains: we are not supplying the neurons with the proper nutrients to create serotonin. So when we force them to create serotonin without energy and we actually hurt the neurons.

We should call this the serotonin generation since we take in more serotonin than vitamins or supplements that were the fad of the earlier times. Today the fashion is SSRIs. But SSRIs are not toys. They are extremely hard for you to stop taking because your body doesn’t know how to stop making the serotonin when the plug is removed. It is in hyper serotonin mode and will have a hard time adjusting to the new environment of “go to sleep.” Plus our brains were so over flooded with serotonin that it has numbed our senses for many discomforts such as pains, hot flashes, sexual behavior, OCD, PTSD, ADD, ADHD, depression, you name it, that without all that numbing “feeling drunkenly good,” we crash and start hurting and act bizarre. We cannot just stop an SSRI. Depending on how long you have been taking one, it can take years to stop taking it and sometimes many years later you get “flashbacks” as I was told by some SSRI stoppers. They are extremely addictive drugs.

They make us stay close to the toilet too since they make us run–often initiating IBS, anxiety, and similar illnesses.

So next time a doctor tells you to take SSRI and it is not addictive, feel free to chuckle and laugh until you fall off the examining table. Because they are more addictive than the feared benzodiazepines! And not only addictive but they modify the brain’s anatomy such that the brain forgets how to live without them. In every which way they are the same as benzodiazepines and worse! They can kill you! Do yourself a favor and do not EVER start taking SSRIs!

Comments are welcome as always!

Angela

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FDA: Epidural Steroid was Off-Label Use? Really? It Was NEVER Approved for That?

Posted on November 4, 2014 by Angela A Stanton, Ph.D.

Oh I thought I can take a day off from typing up blogs but wow!!! Things come at me from friends and colleagues with the speed of light. I am outraged! So here is a new killer article for you!

Who ever in his or her mind would have thought that epidural steroid injections that many insurance companies request to be given prior to surgery were never ever FDA approved procedures?!

Oh my!! Now there is big trouble! Because they were not approved!

There is big trouble on two fronts and let me list them in order of importance where off-label use is number one!

  1. Off-label use of any drug should be illegal! We now have seen several examples where off-label use of a drug hurts people. I have written about off-label use before but let me cover it again in the quick. When the FDA approves a drug, it has extremely strict guidelines for everything, including label which must contain what it is to be used for; how it is used; each dose has a separate label; all adverse reactions must be listed. Nothing can change on this label unless the FDA says it must be changed and when the FDA says it must be changed that is bad news! There is an inconsistency in the labeling of FDA that allows an innocent appearing sentence: “your doctor may prescribe this for causes other than listed” or something similar. This is an under-the-table permit for off-label use. But this is a double-edged sword. On the one hand, the drug is not permitted to be used for anything that is not included on the label and on the other hand it permits the drug to be used for things that are not on the label. I wonder why lawyers are not yet chewing at this sentence from all angles? Is that possible they have not noticed the logical inconsistency? Lawyer? Not noticing? Nah….
  2. The steroid injections used in epidural form to be injected into the spine are now black-boxed by the following strong statement by the FDA:

Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and FDA has not approved corticosteroids for such use

Let me rephrase this making my point: Injecting corticosteroids epidural has been a widespread practice for many decades but FDA has not approved corticosteroids for such use. Wow! They have killed two birds in one swell swoop!

On the one hand they admit to allow an FDA non-approved process to happen and sort of encouraged it for decades??? For decades??? As a widespread practice? And on the other hand they have strict guidelines that will not allow a dot to be changed on the label and all drugs must be approved by the FDA prior to use?

Am I missing something here?

Will someone please tell me why we need to have the FDA? Does it have any reason to exist and oversee the safety of our drugs with such double standard? They look the other way for decades over illegal use of a procedure that ended up hurting people? Oh yeah. Let’s talk about the kind of injuries:

[04-23-2014] The U.S. Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.

Oh I am tickled to tears to know that after decades of people getting hurt the FDA finally puts a new label out–not that it prevents its use even though it admits it does not show any benefit yet either: “the effectiveness and safety of the drugs for this use have not been established” so my question is dear FDA: Why are you letting a drug that is so dangerous as a result of its procedure to be continued?

Those of you who are told by your insurance companies that you should try an injectible corticosteroid epidural before other procedures, please print this article and hand it to your medical provider along with a note that the medical provider and your insurance company must sign: in case I get injured you are all responsible in court! I think you will not be forced to have that injection after all!

And if you are an attorney, please do yourself and the rest of all a huge favor and start a class action lawsuit! This is your chance!

Comments are welcomed and encouraged!!!

Angela

 

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Dehydration & Salt Deficiency May Trigger Migraines!

Posted on November 4, 2014 by Angela A Stanton, Ph.D.

I have started a blogging assignment on migraines and later hopefully on other illnesses as well that connect to hormones. I published part one of a three-part article on migraines, what causes most and what to do when one gets them or prevent them in general. Because migraines connect to hormones (in the brain we call them neurotransmitters), I will be writing these special articles on the blog HormonesMatter. To be sure you understand, migraines are not caused by hormones directly; the lack of hormone development is the one sending the pain signal.

Please visit my article and also browse among the many other articles by members of the blogging team. The blogging team is made up from varying levels of professionals, from those who fell victims of some drug to MDs and PhDs. Most of the articles link to scientific literature that you can find. In mine there are some as well plus also a video on how the cells drink using sodium-potassium pumps in their membranes to “drink” and maintain a healthy productive life. Each cell is precious so handle with care!

Comments both here and there are welcome!

Angela

Posted in Fibromyalgia, Interesting reading, Migraine-Blog, Must Read, This & That, Thoughts | Tagged , , , , , , , , , , , , , , , , | 4 Comments

Aspirin, Heart-attack, & Stroke

Posted on November 3, 2014 by Angela A Stanton, Ph.D.

Aspirin is on TV nearly every day as a the first line defense for preventing heart-attacks. Interestingly, a few months ago, there was a 60-Minute program discussing how new discovery shows that Aspirin doesn’t actually help women in the case of heart attacks but rather help with stroke and for men it helps with heart but not with stroke. This was an interesting story and I wondered why, after this information, Bayer was continuing to advocate Aspirin as heart attack prevention aiming at women.

Well, I suppose my question was answered: Bayer was not supposed to advertise Aspirin for women and actually not even for men who had no heart attacks before!

On May 2nd 2014  the FDA came out with new regulation preventing Bayer to claim that Aspirin provides protection, can prevent, or even help a first heart attack. In other words, Aspirin is not a first prevention medicine anymore. How life changes! And how few listen and pay attention! If you go to visit your doctor today and ask, I bet he/she will tell you to take an Aspirin every day, the baby 81 mg one, to prevent a heart attack once you are over the age of 50.

I hear doctors tell me all the time that everyone over 50 should take a baby Aspirin! Well I guess not! You can read the argument and the final decision with the many case studies that showed no effect of Aspirin on those with first case of a heart attack or prevention of them. Aspirin apparently neither prevents nor helps a heart attack as long as the person does not have a history of heart attacks!

Here is a quote from the FDA’s new regulation:

FDA has reviewed studies on the use of aspirin for the prevention of a first cardiovascular event (primary prevention) and did not find sufficient support for the use of aspirin for primary prevention in these trials. FDA is currently awaiting results of additional clinical trials that are underway and are estimated to have reportable results in the next few years. These clinical trials may provide new evidence that could be the basis for changing the current uses (indications) for aspirin….

FDA recently denied a request submitted by Bayer HealthCare, LLC, requesting a change in the prescribing information for health care professionals (professional labeling) for aspirin to allow marketing of the product for prevention of heart attacks in patients with no prior history of cardiovascular disease.

After the 2003 advisory committee meeting, FDA was aware of several ongoing studies for primary prevention in patients with diabetes and diseases of the arteries and veins located outside of the heart and brain (peripheral vascular disease). We opted to wait for the outcome of these studies. The results of these studies were published over the past several years.  They did not demonstrate a significant benefit for primary prevention….

The Centers for Disease Control and Prevention’s (CDC’s) national initiative, the Million Hearts Campaign, is focused on increasing appropriate, secondary prevention aspirin use in individuals who already have heart disease or stroke.  The CDC, in its Million Hearts Campaign, agrees with FDA’s position.

The National Heart, Lung, and Blood Institute (NHLBI) recommends, as does FDA, the use of aspirin for secondary prevention.  Specifically, NHLBI recommends using aspirin to lower the risk of a heart attack for those who have already had one, and to keep arteries open in those who have had a previous heart bypass or other artery-opening procedure such as coronary angioplasty.

Should you throw your bottle of Aspirin away? If you never had a heart attack, yes, throw Aspirin out. It causes stomach problems, insults GERD further–can create GERD in fact–and its most important benefit that we thought was true is not true. So throw it away until you have a heart attack. Can you prevent heart attack without Aspirin? Absolutely! Eat right, exercise, stop eating sugar, drink more water, be happy. You will less likely to have a heart attack if you have a healthy lifestyle.

When should you take Aspirin? If you already had a heart attack or a stroke, do have Aspirin with you. Depending on what other medications you may take, you may not be able to take Aspirin also unless you are experiencing a heart attack. Thus its use is limited as of now. But stay tuned, things may change! We live in a dynamic world!

Comments are welcome as always!

Addition!

As a comment I received an article that just published by JAMA that is the leading medical research journal. A friend sent it (thanks Roald!) and I thought that for those of you interested in a more technical and scientific data that is most recent will appreciate a longitudinal study that was stopped prior to reaching mid-time of the clinical trial because it showed that there was absolutely no benefit of aspirin on heart or stroke or hypertension or anything on a large population tested in Japan. So Aspirin a day? Nah.. forget it… go for a walk!

Angela

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Do You Have Migraines?

Posted on November 2, 2014 by Angela A Stanton, Ph.D.

Fantastic news to migraineurs who read (or will read) my Fighting the Migraine Epidemic book!!!

I now have received support for the book from 2 companies whose products we often use to keep our body’s hydration protocol high as per my book. Both companies loved the book, are supporting it, and we are now in figuring out how to work together: perhaps they will support some discount to those who read the book by a code or similar.

I know that one of the two companies is starting a medical website and I will be on helping them with that and the migraine book will be a focus. So if you know someone with migraines, please send them to join the migraine group I run on FB since whatever special I receive will only go to those who have my book.

The group’s name: “Migraine Sufferers who Want to be Cured“; a closed group with messages only seen for those who are members.  Please join us if you or someone you know has migraines!

Happy Sunday to you too! ❤

Comments and questions are welcome!

Angela

Posted in Fibromyalgia, Interesting reading, Introduction, Migraine-Blog, Must Read, This & That, Thoughts, Why Me | Tagged , , , , , | Leave a comment

ADD & ADHD; Do You Really Need to Drug Kids?

Posted on October 31, 2014 by Angela A Stanton, Ph.D.

ADD (attention deficit disorder) and ADHD (attention deficit hyperactivity disorder) are more common with children today than ever before. I can see the trend increasing and will probably continue to get worse. We will probably see additional acronyms with more letters describing something that is a response to the environment rather than a disorder.

I personally see ADD and ADHD equivalent in many ways to the teenagers of the 60s when the Beatles were playing. The adults of the then “wise society” said horrible stuff about kids who listened to the trash kind of music the Beatles played. They called for prohibiting that kind of music, etc. Yet look at the Beatles generation today: totally normal, high functioning grandmas and grandpas with love and care who had great lives and jobs and many stories to tell. I happen to be in that generation.

So let’s get to ADD and ADHD. I brought the comparison to how adults reacted to youth listening to the Beatles while falling apart from joy and screaming by scaring adults to wits to that of adults today being scared to wits of kids with ADD and ADHD. It is interesting to note that few people ask why we have children with ADD and ADHD the first place. The obvious choice is to jump in and get rid of it like the music of the Beatles albums. Unfortunately this time the situation is different and the problem now is the adult society to which this is the response of the youth (perhaps getting the heads of those adults who criticize these disorders examined is more in order).

I know, I am heading up the current on the wrong side of the wind. I always do and always will do because common wisdom is common and it is often wrong.

Let’s visit an aboriginal group, or the nomads of Tibet, or the Eskimos, and count the number of ADD or ADHD kids. This will be a very easy job; no calculator needed. The number will be zero. Now get to a city that is buzzing with life, cars, TVs, movies, video games, computers, smart phones, tablets in small, medium, large so you can have one wherever you go. Add thousands of TV and radio channels with news and activity all day and all night. Add stores that are open 24 hours a day 7 days a week. Add lights that are always on. Also add into this epidural painless birth that stall and need to be induced that give contraction too fast for the baby to recover and rest between being squeezed out of the mom and now you have kids with damage from birth and an environment full of sensory over-stimulation 24/7. What is a kid to do to follow it all?

Before I suggest what to do without drugs,  let me also tell you about the drugs they usually give: psychotics to dampen the brain’s activity.

You need to know that the human brain does not mature fully until the age of 35 for men and 32 for women. The last part to fully mature is the most important for making good decisions–hence it is the last to mature. Interrupt this maturation cycle by dampening brain activity and this maturation may never occur. A child’s brain all though his/her growth generates activities in new areas in the brain as the brain has the clock turning on to initiate certain hormonal actions. For example, the terrible 2’s are the age between 2-4. This coincides with the time the child’s brain starts to generate the myelin sheath around the axons of the neurons. Without myelin sheath there is not enough electricity (the sheath is like electrical insulation to keep the voltage going in one direction without leakage) and messages are not yet meaningful. Telling a 2-4 year old who is going through the terrible 2’s to stop being so silly or screaming or holding his breath until he turns purple and faints is about as useful as telling the same to a worm. Telling a 6-year old about consequences of his actions are as good as telling the 2-year old to do calculus.

Kids are  not mini adults with the brain of an adult only smaller. A human child is a child in brain as well and not a mini adult. A child’s brain is just as incomplete as his teeth, as his sexual maturity, as his ignorance of the world. All of these are part of the brain’s lack of ability and not that the child wants to be ignorant.

Some kids are more sensitive to information overload than others; they are the ADD and ADHD kids. Many people (adults too!) are sensitive to information overload–in fact most of us are. The difference is that as adults, many of the things our brains are able to ignore because our brain is developed. A child’s brain is not yet developed and so it will pay attention to all things and will get overloaded faster than adults do.

What can you do if you have a child who has such sensory overload? The symptoms are given everywhere, here taken from Wikipedia:

“An individual with inattention may have some or all of the following symptoms:

  • Be easily distracted, miss details, forget things, and frequently switch from one activity to another
  • Have difficulty maintaining focus on one task
  • Become bored with a task after only a few minutes, unless doing something enjoyable
  • Have difficulty focusing attention on organizing and completing a task or learning something new
  • Have trouble completing or turning in homework assignments, often losing things (e.g., pencils, toys, assignments) needed to complete tasks or activities
  • Not seem to listen when spoken to
  • Daydream, become easily confused, and move slowly
  • Have difficulty processing information as quickly and accurately as others
  • Struggle to follow instructions

An individual with hyperactivity may have some or all of the following symptoms:

  • Fidget and squirm in their seats
  • Talk nonstop
  • Dash around, touching or playing with anything and everything in sight
  • Have trouble sitting still during dinner, school, doing homework, and story time
  • Be constantly in motion
  • Have difficulty doing quiet tasks or activities

These hyperactivity symptoms tend to go away with age and turn into “inner restlessness” in teens and adults with ADHD.

An individual with impulsivity may have some or all of the following symptoms:

  • Be very impatient
  • Blurt out inappropriate comments, show their emotions without restraint, and act without regard for consequences
  • Have difficulty waiting for things they want or waiting their turns in games
  • Often interrupt conversations or others’ activities”

Note the highlighted area also suggested in Wikipedia: these symptoms go away and turn into inner restlessness as the kids get older and become adults. Restlessness in adults does not equate with ADHD anymore, only with kids. Those who remain restless suddenly find themselves labeled with a new category of autism spectrum disorder and it is a spectrum since with cleverness one can put just about everyone into this spectrum. Most of us have some level of inner restlessness and fall somewhere in the zone of this autism spectrum that we now call a disorder.

Again, if you visit an aboriginal tribe, or the nomads of Tibet, or any culture that is not deep into noise, light, and motions stimulus 24 hours a day and you will not find any of this disorders or spectrum. These come with our society today as a result of who we are and what we have become.

What can you do with a child who was labeled with ADD or ADHD?

First, remove the label… it is silly. Second: activate the child to get rid of the built up stress that the over stimulation causes: heavy physical activity that gets rid of built up adrenaline, such as running, hiking, mountain climbing, etc. Do not give the child anything sweet (be it sugar or sugar substitutes!)–if you do, make sure it is on a weekend and let him bounce off the walls. That is what he is supposed to do so encourage him to do that! For breakfast give the child heavy meal: bacon and eggs will do great! If they are overactive in school, enroll them in a before-school running or swimming. Then in school the child will have no energy to be hyper and will more likely be able to focus with the proper foods as well. After school get him to exercise and play before his homework! That way he will be ready for homework as per his chemistry. Make sure he has no sugar (no juices, no sodas, no cupcakes, no candies, no desserts) after dinner. It is hard to tell a kid to eat a carrot if he craves sweets but not impossible. I have a 10-year old granddaughter. I know.

Comments are welcome!

Angela

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And I Thought a Citizen Petition with the FDA Uses the Language of a Citizen!

Posted on October 27, 2014 by Angela A Stanton, Ph.D.

Phew! It took three days! In case you are wondering what this is about: I petitioned against the quinolone drug class Cipro and its generic ciprofloxanin to be used only in case of life and death scenario and remove it from the easy reach of doctors for prescribe it for things other, less dangerous drugs can treat. The first petition I filed is written a few blogs back with instructions and links. I submitted that and received an email from the FDA that I need to make it into a “formal” petition with language so decorated with legal jargon that my eyes are still crossed.

I decided to copy-paste my petition here. For one thing it is public anyway so if and when the docket is read and posted online, you can read it. Secondly, if you find that you would like to file a petition yourself, I have worked out some of the language for you and the sections to be referred to in the petition against this drug. I will be attacking each of the quinolone drugs as time goes. The Cipro is first because that drug is by far the most prescribed oral antibiotic in the US (almost 70% of all antibiotics prescribed today is Cipro or its generic equivalent ciprofloxanin). Over 80% of all of the Cipro-ciprofloxanin drugs prescribed are ciprofloxanin, the generic, and only about 10% of the prescriptions are for the brand name. This causes some problems if you read the blog I wrote before this blog. I hope that limiting the drug’s use to extreme life-death situations only and make it available only in emergency rooms, operating rooms, or intensive care will reduce the side effects to next to nothing but making it available for those for whom there is no alternative.

Here is my petition. If you are also filing, please feel free to use my findings and words:

[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2014]

[CITE: 21CFR10.30]

Angela A Stanton, Ph.D.

Citizen Petition: existing Docket number: 1jy-8f1z-su92               Date: 10/27/2014

The undersigned submits this petition under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs Administration to request the Commissioner of the Food and Drug Administration to amend a regulation that considers Cipro (ciprofloxacin) to be safe for use as antibiotic drug by general practitioners. The Citizen Angela A. Stanton, PhD, hereby petitions to have Cipro (ciprofloxacin) approval to be reconsidered for life and death situations only.

  1. Action Requested

((3) The petition requests from the Commissioner to take action on behalf of those already injured and those yet to be injured in the future if no action is taken, to prevent such injuries possible on a large-scale by making the drug Cipro (ciprofloxacin) only available in very special cases, such as in the case of life or death and only in the care of emergency rooms, surgical procedures, and intensive care units.

  1. Statement of Grounds

The current approval of Cipro (ciprofloxacin) is based on the safety of the drug | NDA 19-537/S-409, NDA 19-857/S-031, NDA 19-847/S-027, NDA 20-780/S-013 to Bayer Pharmaceutical Corporation from the Center for Drug Evaluation and Research at the Department of Health & Human Services. Application No.: 019537s049, 019847s027, 019857s031 & 020780s013; Approval Date: 03/25/2004

At the time of the approval, the indication for prescription Cipro (ciprofloxacin) was for the following illnesses as per original labeling found at (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s049_019847s027_019857s031_020780s013_Lbl.pdf) in lines starting at 307 “INDICATIONS AND USAGE” through line 505 (emphasis added and some conditions of irrelevance left out)

“Adult Patients:

Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae. Serratia  marcescens, Proteus   mirabilis, Providenci  rettgeri Morganell  morganii,  Citrobacter diversus,  Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Acute Uncomplicated Cystitis in females caused by Escherichia coli or Staphylococcus saprophyticus. Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis. Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter  cloacae, Proteus  mirabilis, Pseudomonas  aeruginosa Haemophilus   injluenzae,  Haemophilus parainjluenzae, or Streptococcus pneumoniae. Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis.

NOTE:

Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae. Acute Sinusitis caused by Haemophilus injluenzae, Streptococcus pneumoniae, or Moraxella Catarrhalis. Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella  pneumoniae, Enterobacter  cloacae, Proteus  mirabilis, Proteus  vulgaris, Providencia  stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas  aeruginosa, Staphylococcus aureus (methicillin-susceptible), Staphylococcus  epidermidis, or Streptococcus pyogenes. Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Complicated Intra-Abdominal Infections  (used in combination  with  metronidazole)  caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis. Infectious Diarrhea caused by Escherichia  coli (enterotoxigenic strains), Campylobacter jejuni, Shigella boydiit, Shigella dysenteriae, Shigella jlexneri or Shigella sonneit when antibacterial therapy is indicated. Typhoid Fever (Enteric Fever) caused by Salmonella typhi.

NOTE: The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated. Uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae.”

Today, October 27, 2014, there are many antibiotic treatments available for most of the illnesses listed above that have proven as effective and cause fewer side effects than Cipro (ciprofloxacin).

The safety advisory warning on the label of Cipro (ciprofloxacin) has been amended several times as a number of adverse effects, unknown at the time of approval, have surfaced. Some of these side effects include damage to the central nervous system that is listed on the original approval as: nervousness, agitation, insomnia, anxiety, nightmares or paranoia. Phototoxicity: Moderate to severe phototoxicity manifested as an exaggerated sunburn reaction has been observed in patients who are exposed to direct sunlight while receiving some members of the quinolone class of drugs. Excessive sunlight should be avoided. The adverse reactions warnings also suggested that it is important to avoid excessive sunlight or artificial ultraviolet light while receiving ciprofloxacin and to discontinue therapy if phototoxicity occurs. Furthermore it was advised to discontinue treatment; rest and refrain from exercise; and inform their physician if patients who took ciprofloxacin experience pain, inflammation, or rupture of a tendon.

Under Drug Interactions (lines 506 through 540, also emphasis added and only concerns of importance listed)

“As with some other quinolones, concurrent administration of ciprofloxacin with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination half-life.

Some quinolones, including ciprofloxacin, have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of its serum half-life.

Animal studies have shown that the combination of very high doses of quinolones and certain non-steroidal anti-inflammatory agents (but not acetylsalicylic acid) can provoke convulsions”

Please note that at the time of the drug interactions listed, it was not known that any NSAD taken together with quinolones such as Cipro (ciprofloxacin) at standard low doses also causes major interactions. It was also not clear that the prescription of steroid drugs for use in combination with Cipro (ciprofloxacin) also in low dose caused major adverse reactions. While prescribing quinolones, such as Cipro (ciprofloxacin), as usual, doctors and pharmacies have not apparently heard or read the message and even today continuously prescribe Cipro (ciprofloxacin) and steroid and/or NSAD, causing major and often irreversible complications. Some adverse effects happen immediately upon taking the first Cipro (ciprofloxacin) tablet, others later but prior to finishing full prescription and yet other several months later! This makes the connection to Cipro (ciprofloxacin) very hard to prove pending blood tests that are now being developed and used to evaluate the reasons for the damage.

FDA Adverse Effect Update:

To date there have been two FDA requests for label change on Cipro (ciprofloxacin) and other quinolone class drugs: 2012 and 2013. This is indicative that some of the adverse reactions appear years after the drugs were taken and not always after the first application—as if there was a threshold level for each person beyond which there is no return.

FDA updates on the adverse effects of fluoroquinolones drugs, including Cipro (ciprofloxacin) in 2012 states:

“The results of FDA’s recent review of the Adverse Event Reporting System (AERS) database indicate that although the risk of peripheral neuropathy is described in the drug labels of each marketed systemic fluoroquinolone, the potential rapid onset and risk of permanence were not adequately described. The recent AERS review evaluated cases of fluoroquinolone-associated peripheral neuropathy with an outcome of “disability, reported between January 1, 2003 and August 1, 2012. The review showed a continued association between fluoroquinolones use and disabling peripheral neuropathy… FDA has required manufacturers of systemic fluoroquinolone drugs to make revisions to the drug labels (Warnings/Precautions and Warnings and Precautions sections) and the Medication Guides. These label changes are to better characterize the risk of peripheral neuropathy associated with the class of systemic fluoroquinolones. If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be treated with an alternative non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.” (page 3 on http://www.fda.gov/downloads/Drugs/DrugSafety/UCM365078.pdf)

This particular label update by the FDA did not yet state that peripheral neuropathy can be permanent and other conditions, such as tendon tears (partial or full) can be permanent disabling conditions. Though it mentions the seriousness, it does not equate the serious condition to patient suffering and quality of life altering complications.

FDA updates on the adverse effects of fluoroquinolones drugs, including Cipro (ciprofloxacin) in 2013 states:

 “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection” requesting that the label of all approved fluoroquinolones drug labels be modified with the possible permanency of peripheral neutropathy, a condition affecting the central nervous system, often causing permanent disability.” (Emphasis added)

Please note that still in the second label change the FDA does not mention the importance of patient suffering and the disabling condition resulting from tendon injuries. As a tendon injured citizen, I can attest to the drug’s permanent disabling effect in pain as well as ability to walk and accomplish work.

It is important to note that now there have been many scientific studies showing the oxidative effects of quinolones, in particular that of ciprofloxacin (Talla, Veerareddy, J Young Pharm. 2011, Oct-Dec; 3(4: 304-309), DNA mutations as a result of fluoroquinolones (Pallo-Zimmarman et al., Compendium, July 2010: E1-E9), Mammalian Mitchochodrial cell damage (Kalghatgi et al., Sci Transl Med 5, 192ra85 (2013)), the effects of UV A light on fluoroquinolones (Perrone et al., Toxicological Sciences 69, 16-22 (2002): 16-22). Additional studies show that the damage of “sun” is not just that of enhanced sunburn predisposition during the period of taking quinolones, including Cipro (ciprofloxacin), but that the phototoxicity implies an underlying further damage to mitochondrial DNA and whether the UV light is A or B matters (Akter et al., Free Radic Biol Med. 1998 May;24(7-8):1113-9.; Dykens, et al., Expert Review of Molecular Diagnostics [2007, 7(2):161-175] (2007): 161-175).

In light of all these adverse effects whose importance is noted but underestimated even in the second label update request by the FDA, as a citizen I petition to modify the label of the quinolone drugs, starting with Cipro (ciprofloxacin) as a result of oxidative stress and DNA mutation causing permanent damage and lifelong disability in the human body. I petition to modify the label providing instructions to practitioners,   permitting only limited access to the drug based on life threatening circumstances and made only available in emergency rooms, surgical procedures, or life saving measures in intensive care.

It is my belief that at this point the drug’s benefits, for treating simple infections that can be treated by less harmful medicines, have been exceeded by the injuries it causes as adverse effects, which are often irreversible. It is also my experience – consistent with the FDA database – that the quinolone drug class, especially Cipro (ciprofloxacin) is the most often prescribed oral medicine for any and every bacterial infection, no matter what the cause. The over-prescription of this drug has caused a decline in its effectiveness. This further strengthens the argument that the risks of taking this drug now greatly outweigh the benefits it provides.

In order for the benefit of the drug to be outweighed by its adverse effects, the adverse effects need to be temporary and less than debilitating to handicap level and the benefit must be significant. Since many of the adverse effects are now understood to be long-lasting, some irreversible for life, and Cipro (ciprofloxacin) is losing its effectiveness in light of many resistant bacterial classes, Cipro (ciprofloxacin) has exceeded the expected benefits with respect to adverse effects and thus should be removed from everyday use.

1. Environmental Impact

N/A

2. Economic Impact

N/A

3. Certification

The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

______________________________________________________________(Signature)

Angela A. Stanton, Ph.D._____________________________(Name of petitioner)

_____________________(Mailing address)

______________________(Telephone number)

Your comments are welcome as always!

Angela

 

 

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You Can Only Sue Brand Name Drugs that are Never Prescribed!

Posted on October 26, 2014 by Angela A Stanton, Ph.D.

With the exception of two states in the United States, people who got floxed by quinolones antibiotics or got sick from any medication can only sue the brand name manufacturer, but only if the drug that got them sick, was a brand name drug.

Quick, hands up: how many of you actually take brand name drugs?

I had a conversation with the FDA and the pharmacist I talked to about brand name versus generic told me that over 80% of all drugs that have generic versions get to only be prescribed as generics. That means bad news to those getting hurt on a medication that is generic.

Now pardon me for my mathematical logic here but I cannot help but poke fun of a system that

1) mandates that all generic drugs must have the exact active ingredient as the brand name and

2) that all generic drugs must be bio equivalent to the brand name.

If the generics are exact copies of the brand name in terms of bio equivalency, which was specifically explained to me by the FDA that it considers where the drug dissolves and how it absorbs, then the two drugs are the same. Thus

generic = brand by all law, which means brand = generic by the same law => whether you get sick from the brand or the generic, shouldn’t matter. The problem is with the brand name since the generic is an identical bio equivalent copy. 

So why can’t you sue the brand name manufacturers if you took generic drug? Why can you only sue the brand name manufacturers if you took the brand name drug? This would imply that the generic and the brand name drugs are not the same; right? But they are the same by the law. So what is going on here? A game. This is politics and fraud big time! 

What can you do to prevent this game?

1) move to the states that allow law suits against generics

2) allow only brand name drugs to be prescribed and make sure the doctor writes on the prescription “do not substitute for generic” and that will ensure your lawsuit chance should something go wrong. 

The problem is of course the cost. Most insurance companies will only cover the generic so then if you get sick, there is not much you can do. For now, try to always convince the insurance company that you must have the brand name. You have no alternative! Remind the insurance companies that of course you can always sue them from forfeiting your right to sue brand name manufacturers by only allowing prescriptions for generics!

Comments are welcome as always!

Angela

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Is This Really The Industry’s Response to a Preventable Illness? Eek!

Posted on October 23, 2014 by Angela A Stanton, Ph.D.

I am posting a copy-paste here from Facebook from the Neuropathy Association site so you can see how the industry views those who have been hurt by the quinolone class drugs, such as Cipro and others. Please read. The industry answer will shock you. I placed the Association’s answer as a quote so you can distinguish easily:

Aliza’s question:

Hello Dr. Levine: I have, let’s say, “full body” nerve damage, to put it simply, (CNS damage as well as multi-systemic PN, basically everything from head to toe) — as do most of my fellow “floxies” (people with FQ Toxicity Syndrome due to Fluoroquinolone antibiotics)… and what I’d really like to know is…
…. how on earth is it even possible for so many Dr.s — including Neurologists — to STILL be so unaware of FQ toxicity — and it’s well-documented links to neuropathy??
I’m not a “Dr. basher” and I by no means wish to offend anyone. But at the same time, the ignorance is inexcusable! There are thousands upon thousands of us who desperately need help and aren’t getting it. We’re left to try to self-diagnose and self-heal because our Dr.s aren’t keeping up with with medical developments and/or are refusing to see the writing on the wall with regard to FQs (while even the FDA has a black box warning that they can cause permanent peripheral neuropathy and law suits are springing up.)
Thank you in advance for any input you can give on this all-too-common problem.

Response by the Neuropathy Association doctor:

Aliza,
I am not sure how to answer your question. I am sure it can [be] frustrating for physicians not to be aware of this. From a neurologist perspective I would just say that once toxicity develops our management of the neuropathy does not differ from that of other neuropathies.In other words, we use medications to treat the symptoms (such as gabapentin or Lyrica).
DS (corrected for errors and emphasis added)

There are many answers to this particular thread and for lack of permission from the individuals to show their identity I will only post my response:

  • DrAngela A. Stanton When I first read the response of the doctor here, I nearly fainted. So, Dr. DS, what you are suggesting is that the medical community should be choosing to treat symptoms of a preventable disease rather than prevent it? Here the cause of neuropathy is clearly evident. Really?People die, commit suicide in their pain from the side effects of the drugs and your association suggests to take Lyrica (a horrible drug that is so addictive it takes years to get off) to treat the symptoms instead of stopping the cause from happening altogether?There are very few illnesses in our lifetime we know the precise cause is preventable. This is one of those. We know what is causing it. What happened to the oath of “DO NO HARM”?It is a shame on the medical industry (including your company) that making money on the sick by treating it rather than prevent it is “better” for you. Am I correct in my assumption? Since your answer translated to that precise statement to me.

    If I am correct, we have some massive work to do to interrupt the methodologies of the industry that lives off of the pain and suffering of others.

    Comments are welcome as always and now more than ever! This is now a blog of shame!
    Angela
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One Life Less Because of Ciprofloxacin (Cipro)! In Honor of One Who Died!

Posted on October 23, 2014 by Angela A Stanton, Ph.D.

I never thought I had to come face to face with a drug that hurts so many in such a terrible way! I certainly have not thought that I will learn from the family of a member who took his life because it was destroyed by antibiotics! This is  the drugs in the quinolone family. He was prescribed two kinds: Ciprofloxacin and Ofloxacin.

Those of us who have come face to face with the dangers and side effects of quinolone family of drugs, most commonly Cipro (brand name) or Ciprofloxacin (generic) in prescriptions (almost 70% of prescribed oral quinolones is represented by Ciprofloxacin or Cipro per the FDA database), understand why Dick Decent committed suicide after these drugs have destroyed his life. His sister posted her comment on one of my previous blog posts. Dick left behind two children. And all he did was take two antibiotics, both in the quinolone family of dangerous drugs that for some reason the FDA continues to permit to be prescribed for simple infections that can be treated by other antibiotics equally well in most cases.

I decided to honor Dick with this blog post to share his family’s pain and to let you all know that these drugs are serious damaging drugs and apparently killers as well. I list again the drugs here for you–some have already been pulled from the market but many the FDA continues to permit. Cipro itself has a 43-page warning of adverse effects that apparently no doctor or pharmacist will tell you about. I post here the generic first and brand names (many since they are under different names in different countries). The information is from Wikipedia, where you can read up on each drug at your convenience.

Please make sure that if you had an adverse reaction or know someone who had–even if that adverse reaction is listed on the package insert as expected–report it to the FDA on their online submission form. They need to hear your voice! They need to hear it happened to you too so that it does not take more lives and it does not have to happen to others!

The list of drugs for human use–I crossed out those already removed from the market and highlighted in bold those causing the most well-known problems so far:

First-generation:

Second-generation

The second-generation class is sometimes subdivided into “Class 1” and “Class 2”

Third-generation

Unlike the first- and second-generations, the third-generation is active against streptococci.

Fourth-generation

Fourth-generation fluoroquinolones act at DNA gyrase and topoisomerase IV. This dual action slows development of resistance.

In development

Please check to make sure you are not taking any of these drugs for simple infections that other drugs can treat equally well. These drugs should remain to be used and possible to be prescribed to only those in life and death situations when there are no alternatives!

Comments are welcome!

Angela

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