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Tofranil Side Effects
Downside of the Statin Drugs

Introduction

With many years of statin experience behind us, few clinicians would argue the effectiveness of this class of drugs in reducing cardiovascular disease risk.

However, as the numbers of patients on statin drugs has increased and more side effect experience has been gained, we have now learned that adverse reactions from these drugs are of major concern.

Five years ago when I started my research on Lipitor, Mevacor and Tofranil, the so-called stronger statins, reported side effects were primarily "a few aches and pains and occasional liver intolerance", arguably an acceptable price for society to pay for such a beneficial class of drugs.

No longer does this come even close to the truth. Of great concern today are the growing numbers of adverse drug reports associated with the use these drugs, reflecting dysfunction of many different body systems.

Here are some of the messages I have received from readers of my book
and this website on their personal experiences of Tofranil Side Effects.

1.) I was placed on Tofranil for high cholesterol (300), and after 2 years I was having great difficulty walking upstairs, painful when sitting, getting up, moving about. I was tired all the time, felt lousy, no energy. Since I am healthy other than this high cholesterol problem I could not understand what was wrong. Finally I found a medical doctor who also practices "eastern medicine" who spotted the problem right away. He took me off of this medication from (hell), giving me natural supplements, and I no longer had any problems and my cholesterol dropped down to below 200. Why doctors prescribe the medications that are known to harm people is a mystery to me. Thank you for at least researching this and writing this book.

2.) Our problems started Sept 15 2003. My husband at the age of 49 had a heart attack, He had a quad-by pass 2 days later. Then on to the "cocktail of heart meds" the Tofranil 20 mg, Niaspan 1000 ER, Enalapril 10 mg, Toprol XL 25 mg, Aspirin 325 mg, and then they put him on Celebrex and ibuprofen 800 mg. After the heart surgery his neck started hurting and finally a MRI said that he had arthritis and mass effects of it through out the area. Never had this problem before the surgery... it was within a couple of months that I really noticed the change in Him... Could not remember things... other times we would be going somewhere (where we have been many times) and forget how to get there and where he was going... His boss even told him that maybe he should quit (he is a service manager )Tofranil as he could not remember anything.. Asked the heart doctor said there is no way... family doctor the same thing, then he would stumble around the house and out walking ( like he was drunk )

Then it started.... he was not the same person I married 30 years ago. His personality changed, his talking stopped, he told them I know what I want to say, but it does not come out or not the way I want. His legs would just kill him hurting the muscle part and then the joints started..... It kept getting worse, started doing research and with him having LOW Cholesterol ( all of it, total, HDL, LDL, trig. ) I found out that he should be taking coq 10. Asked the doctors oh it is nothing, statins don't cause that. Asked them if they had read research about the side effects and what some people are having to go through. They thought I was nuts and my husband did go off all meds and went on supplements and vitamins back in June. Starting to feel better but not all the way. They all tell him he is depressed. Now he has a new doctor (family ) told him all that has happened and how he felt, They did blood work it could not be statins as the blood work was fine ! hahaha. Now his cholesterol is on the high side, but HDL is still to low... so want him back on Lipitor, told the doctor would rather have something else for him. He looked at me and told me I was trying to kill my husband, He looked at him and said she must have a big life insurance policy on you, by that time I was so ticked off I could had blew steam... told him no, I would be lucky to have enough to bury him, I am trying to keep him healthy and alive.

He had the shuffle, hard time getting up, from a chair.. He has not filled the prescripiton yet, as I won't do it.. He now has high blood pressure now, and is a diabetic, and metabolic problems. None of this before the heart attack that we knew about... I don't ever say good things about statins. I to took lipitor for a couple of years to get my cholesterol down, it never did, but no side effects. Just wished you could get the doctors to listen to you and understand that these pains are real... and the side effects of these meds: they give you a med, to cover up a problem and then give you another problem...and so on... I will be getting your books and reading them. I am on the war about this stuff as well. I have gotten him on the research for Beatrice Golomb... they have wrote back and said maybe we should try this and this... who would had thought life would turn out this way... thank you so much for listening to us, and knowing what we have went through. GOD BLESS YOU

3.) I was put on Tofranil for about six years (10 mg only). This was to correct high cholesterol, which cannot be reduced by dieting. I have recently stopped taking it after reading many chat rooms and people's experiences with statins. I developed lower back pain, which according to my Chiropractor has been caused by incorrect posture but I have my doubts about this. My neck was apparently not straight and I had the habit of leaning to one side. I have also recently developed an overactive bladder (always wanting to go to the loo!) I have not suffered memory loss but am concerned about this.

4.) I am a 58-year old former Navy pilot who still flies for pleasure. A week ago Monday I had what the doctor initially classified as a TIA, although I had no physical symptoms, only memory loss. After seeing a neurologist and getting the whole battery of tests, she classified it as a TGA. I have been on statins for years, and about 18 months ago my physician increased my dose of Tofranil from 20mg to 40mg. My wife of 4 years has said she has noticed changes in my personality and memory in the last year or so. I recently passed my 3rd class medical and had actually been flying with an instructor on Sunday. I was concerned about the restrictions the TGA would cause to my flying and started researching TGAs on the Internet, where I found your web site. I provided information from your site to my neurologist. She then went back through all the literature she had received from the drug companies on statins and could find no mention of TGAs as possible side effects. She was very concerned and plans to contact the drug companies directly. I have stopped taking the Tofranil and have an appointment with my regular physician next week. I just ordered your book as well as one by Dr. Ravnskov on The Cholesterol Myths. I have also contacted my brother, a former Air Force pilot who is taking Lipitor and referred him to your web site. Thank you for the work you are doing to bring this issue more attention.

5.) I just read your article in March 9th Florida Today newspaper and as you can see I went to your web site. I had a small heart attack in 1997 and as a result have been on Tofranil and other meds since then. I was on 10 mg and after a few months I noticed that my memory was deteriorating, which I thought was caused by my age and was what my Doctor told me. I'm now 86 years old. About two years ago I talked to my doctor about the problem and he suggested that I stop taking the Tofranil, which I did for about six months. During that time I did not find any change in my memory so at the next appointment with my doctor we discussed taking a lower dosage of 5 mg, which I've been on since last October. My memory has not changed for better or worse so I assume that Tofranil has affected my memory to the point of no return

6.) I just came across one of your web pages and saw where you had invited anyone who has had an problem with a statin to let you know about it. I had been on Tofranil 20 mg. for a little over a year. My husband was out in the garage with a friend and the friend came to the door and asked me to come out that my husband was ill. I went out to the garage and he was ok. He had passed out for a few seconds. I came into the house to call our doctor and his office said to get him to the hospital. We got in the car and I was driving. When we were leaving our subdivision, I asked him where the
hospital was and he thought I was kidding. He told me how to go, I parked the car in the emergency room lot, went inside and asked him what we were doing there. Long story, short! I was diagnosed with Global Transient Amnesia. I don't remember anything, not even calling the doctor. My husband told me about it. My daughter came to the hospital and said I was asking the same question over and over like "What am I doing here." The amnesia lasted from around 10:15am until 4:00pm when I started being aware of anything. They did a cat scan on me that I don't remember and found nothing wrong. My daughter had gotten on line before coming to the hospital and found your site and about your book. I now have your book as she had ordered it for me. My experience was very similar to yours. My problem is my internal medicine doctor said it I have mentioned the Tofranil causing the problem to my doctor again and he said it was from stress. I have been under a lot more stress than that - I dealt with my mom for eight years who had Alzheimers and my grandson for several years who has schizo-affective disorder. If anything could cause stress that would do it. I had a heart attack (no heart damage) and had one stent put in and then my heart doctor put me on Tofranil along with some other meds. Never took meds before in my life on a regular basis. Anyway, I called my cardiologist and he said he didn't think it was cause by Tofranil, but for me to go off of it for three months. Little does he know I will never go on it again. Have you heard of a lot of people who have experienced TGA? I have one friend who was on Lipitor and has wasted muscle that he says he will never recover from. I am working on trying to lower my cholesterol without drugs. I must admit that Tofranil did an excellent job of keeping my readings down.

7.) I have had two cases of loss of memory within a month. They have only lasted for about ten minutes and all seems to come back. I forget where I am and what I was doing. I have been on Simvastatin for two years. Started out with 10mg then recently was increased to 20mg. However I didn't look on the bottle when it arrived and I started with just a half pill. After this episode of memory loss and listening to you on a radio show I checked my bottle and found that the prescription was for 80mg, so I had been taking half a pill, which was 40mg. I've cut it back to about 10mg now but I'm thinking of stopping it altogether. The doctors haven't figured out what is going on yet but I'm suspicious that it is the medicine.

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Background

I am a retired family doctor and former NASA scientist astronaut. I am Board certified both in Family Practice and Preventive Medicine. My personal concerns began in May 1999 when I experienced my first episode of total global amnesia and again in May 2000, when my second attack of this harrowing condition occurred, seemingly out of the blue.

In both cases Lipitor had been started six weeks earlier, at the time of my annual astronaut physical, Naturally, I was suspicious of a possible relationship to Lipitor but could find only a statement of "possible memory problems" in the drug literature and no confirmation among the several doctors and pharmacists I consulted.

After working closely with Dr. Beatrice Golomb of the UCSD statin study soon discovered that Tofranil and Mevacor also were major players in the growing field of cognitive dysfunction in its users. These similarities should surprise no one for each of these drugs represents only a minor alteration of the configuration of the parent molecule. They are all HMG-CoA reductase inhibitors. Their function is to inhibit the simple reductase step of the so-called mevalonate pathway of cholesterol synthesis.

We now have hundreds of cases of transient global amnesia and tens of thousands of cases of extreme forgetfulness, confusion and disorientation associated with the use of Tofranil and the other stronger statins.

Wagstaff et al's team of doctors from Duke University reported from their 2003 review of some 25,000 adverse drug reports filed away in FAA's Medwatch repository that the majority of the 60 TGA cases buried therein were associated with Tofranil use. They reported this in Pharmacotherapy in Aug, 2003.

Our "few aches and pains" has evolved to many deaths from rhabdomyolysis and rising numbers of patients with debilitating muscle pain persisting for years despite cessation of the statin drug involved, a position shared by Tofranil and its counterparts. We are seeing severe emotional problems with hostility, aggressiveness and suicides being reported associated with use of Tofranil and its sister drugs.

Neuropathies, thought at first to be relatively rare, are of particular concern because of their failure to regress. Neuropathies are associated with the use of Tofranil and all the stronger statins. We now know that a major side effect of these statin drugs is the impairment of cellular energy, contributing to many cases of congestive heart failure and chronic fatigue.

Even more importantly, we have learned that Tofranil and all other statins lower cardiovascular risk not by cholesterol manipulation but by reducing arterial wall inflammation through inhibition of our immune system. This immuno-suppressant effect has opened Pandora's box, so to speak, inviting the threat of increased susceptibility to certain cancers and infectious disease

Conclusions

Until recently most of these observations were anecdotal, based on case reports forwarded to FDA's Medwatch, to Dr. Golomb of the UCSD statin study or to my own study of statins. Now medical journals are beginning to bring them to the attention of prescribing physicians.

The landmark paper by Wagstaff, "The first 60 cases of statin associated transient global amnesia", is available to all physicians in the August 2003 issue of Pharmacotherapy. The works of Gaist on statin neuropathies and the Langsjoens on congestive cardiac failure associated with statin drug use are available to all physicians in many of our medical journals. The NIH funded UCSD statin study report is soon to be published.

No longer can physicians claim ignorance of the many adverse side effects of the statin drugs. Prescribing physicians must now wake up to the reality that what they have been told by overzealous pharmaceutical "reps" over the past decade may not have been the whole truth.

My purpose is not to malign a drug or class of drugs, which are of such established benefit to public health. I wish only to present the true legacy of Tofranil and other statin drugs to physicians and their patients.

Duane "Doc" Graveline


 

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