5/24/2000 – Effexor – FDA Discontinuation Warnings

Thanks to Steve Whiting for alerting us to the following warnings from the
FDA. It is about time the gave us some warning about the terrible withdrawal
associated with the SSRI and SNRI antidepressants. I have highlighted a few
spots in this warning that I want you to take note of in particular.

Knowing HOW TO safely withdraw from serotonergic medications is one of the
most critical pieces of information patients need about these drugs –
information they are unfortunately not getting from their doctors. How one
withdraws can make the difference between life and death and can prevent the
long term debilitating effects that come from an abrupt or a much too rapid
withdrawal. Let me remind you once again that I have made an hour and a half
long audio tape to give patients and doctors withdrawal tips on safe and
successful withdrawal from these drugs as well as information on rebuilding
the body after their use. I could not longer find time to eat or sleep
because I was spending all of my time answering questions from doctors and
patients about safe withdrawal. A tape answering those questions seemed the
logical solution. The tape is inexpensive and very helpful. You can find
order information at

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org
________________________________

The FDA has forced safety related drug labeling changes regarding Effexor.

The changes acknowledge the existence of severe
discontinuation problems which are both dose and time
related and that the evidence of the problems has been
obtained from a retrospective survey of the clinical trials
database.

Steve Whiting
http://www.effexorfx.freeuk.com
__________________________

Please refer to
http://www.fda.gov/medwatch/safety/2000/mar00.htm#effexo

EFFEXOR & EFFEXOR XR (venlafaxine HCl) Tablets
[March 3, 2000: Wyeth-Ayerst]

DRUG ABUSE AND DEPENDENCE:

Physical and Psychological Dependence: New third paragraph –
“Discontinuation effects have been reported in patients receiving venlafaxine
(see DOSAGE AND ADMINISTRATION).”

DOSAGE AND ADMINISTRATION:
Discontinuing Effexor (venlafaxine HCl): First sentence revised –

“When discontinuing Effexor after more than 1 week of therapy, it is
generally recommended that the dose be tapered to minimize the risk of
discontinuation symptoms. Patients who have received Effexor for more than 6
weeks or more should have their dose tapered gradually over at least a 2-week
period.”

New second paragraph –

“Discontinuation symptoms have been systematically evaluated in patients
taking venlafaxine, to include prospective analyses of clinical trials in
Generalized Anxiety Disorder and retrospective surveys of trials in
depression. Abrupt discontinuation or dose reduction of venlafaxine at
various doses has been found to be associated with the appearance of new
symptoms, the frequency of which increased with increased dose level and with
longer duration of treatment. Reported symptoms include agitation, anorexia,
anxiety, confusion, coordination impaired, diarrhea, dizziness, dry mouth,
dysphoric mood, fasciculation, fatigue, headaches, hypomania, insomnia,
nausea, nervousness, nightmares, sensory disturbances (including shock-like
electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting. I
t is therefore recommended that the dosage of Effexor be tapered gradually
and the patient monitored. The period required for tapering may depend on the
dose, duration of therapy and the individual patient. Discontinuation effects
are well known to occur with antidepressants.”

Discontinuing Effexor XR:

“When discontinuing Effexor XR after more than 1 week of therapy, it is
generally recommended that the dose be tapered to minimize the risk of
discontinuation symptoms. In clinical trials with Effexor XR, tapering was
achieved by reducing the daily dose by 75 mg at one week intervals.
Individualization of tapering may be necessary. [The remainder of the
paragraph beginning with “While the discontinuation effects of Effexor XR
have not been systematically evaluated in controlled clinical trials,
retrospective…” has been deleted] and replaced with –

“Discontinuation symptoms have been systematically evaluated in patients
taking venlafaxine, to include prospective analyses of clinical trials in
Generalized Anxiety Disorder and retrospective surveys of trials in
depression. Abrupt discontinuation or dose reduction of venlafaxine at
various doses has been found to be associated with the appearance of new
symptoms, the frequency of which increased with increased dose level and with
longer duration of treatment. Reported symptoms include agitation, anorexia,
anxiety, confusion, coordination impaired, diarrhea, dizziness, dry mouth,
dysphoric mood, fasciculation, fatigue, headaches, hypomania, insomnia,
nausea, nervousness, nightmares, sensory disturbances (including shock-like
electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting.
It is therefore recommended that the dosage of Effexor XR be tapered
gradually and the patient monitored. The period required for tapering may
depend on the dose, duration of therapy and the individual patient. Discontinu
ation effects are well known to occur with antidepressants.”

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Marge’s Story–Her Fateful Experience on Paxil and Effexor

“…this stuff has to come off the market.”

 

An Introduction by Ann Blake-Tracy

This is Marge’s story – a follow up story to the months and months of trauma brought on by three weeks of Paxil and a dose of Robitussin. (The combination produces Serotonin Syndrome.) For Marge this produced a movement disorder and caused her hands to swell to the point she could no longer work. She was subsequently given a diagnosis of Scleraderma. She never recovered from this toxic serotonin reaction – the first injury. After many months of suffering she was told she had to have a breast removed.

In this letter she takes the story from there to tell of the horrors of a second SSRI drug-induced injury that in the end cost her life this time.

Marge passed away several months after this letter was written leaving her husband and two daughters. She was a wonderful and incredible woman who had a brilliant sense of humor that shines through her story. Marge wanted her experience to be a lesson for others. Please heed her warning.

She would ask now as I continue to ask, “HOW MANY MORE HAVE TO DIE?”

Dr. Tracy

Dear Ann,

I hope that you are well. I am so grateful to you for all that you have done.

I would like to brief you on the past 3 months because I think that it is so important for you to know. Perhaps the only reason I was placed here on this earth was to screw up with antidepressant medications so as to add more fuel to your fire. I promise to be as brief as possible, though this is a good one.

As of this past spring, the psychiatrist I was working with prescribed Effexor and lorazipam. I just could not recover from the last medication reaction and my depression was the worst it had ever been. I had been working with this very compassionate psychiatrist for almost a year, and although we hadn’t found any medication that worked, none of them seemed to be making me ill. I tolerated Effexor at low doses (37mg) and seemed to be responding so he raised it to almost 200mg by July. I developed a cough. Strange! I had never had a morning cough before. But at 200mg of Effexor + Lorazipam, who cared? 🙂 The cough became severe rather quickly, along with substernum chest pain. The bottoms of my lungs felt heavy and full. I kept remarking to the psychiatrist that I couldn’t sneeze because I couldn’t take in enough air. He reminded me that I didn’t like medications, so this was probably my imagination. He encouraged me to go to my family physician if I wasn’t feeling well, but I knew that this would just result in a prescription for Robitussin and I wasn’t about to play that game again. I was too drugged to think straight anyway, so I just slept the entire summer away. Even sent my family to California without me so that I could sleep in peace.

By September I knew that I was in trouble. The cough was now terribly frightening to my family and constant. It was spasmodic, and came from my toes. I couldn’t sneeze at all and felt generally lousy. So, I started to take myself off of the medication, but slowly, because my psychiatrist was very much against this and I was as frightened of rebound depression as anything else.

September 29th I was scheduled for implant surgery. This, I was told, was a simple surgery. One night in the hospital and one week to recover. My chest was still not anywhere near right, though it had improved. I was now on only 37mg. of Effexor once again, and the situation was correcting itself, though slowly. I was walking regularly in an effort to clean out my lungs. By now, I had also personally investigated the side effects of this drug, which of course include frequent coughing, substernum chest pain and congestive heart failure. But, as the doctors have told me over and over again in the past 3 months, “They never see this.” – There are none so blind as those we call M.D.

So I went in for surgery, September 29th, and was not doing well after the operation. An hour after being sent home by a hospital that routinely dismissed me, I was raced back to our local hospital because I couldn’t breathe. Congestive heart failure. Into ICU I went where 15 pounds of excess fluid was pumped out of my body. (I am only 5’1″ tall). Everything began to return to normal, oxygen levels, etc., but the nasty cough continued and the pulmonologist saw some strange lines on my x-rays that bothered him. So he sent me for a CATSCAN. POW! The next day, my family physician calls the hospital to inform my husband that I had lung cancer in the lower lobes of both lungs, inoperable, and that I had a tumor in my spine. My husband tearfully delivered the news to me. My children arrived at the hospital shortly thereafter and we all cried the tears of impending doom.

After being stuck in ICU for a week, due to a weekend where no doctors were available and difficulties in scheduling my tests, I demanded to go home. A week of solitary confinement, sitting on this kind of news, fresh out of a surgery which was painful, was enough for me. We immediately scheduled an appointment with the recommended oncologist, who told me I had a 70/30 chance to live and he wanted an immediate biopsy of my spine. By now I had taken myself off of the drugs completely, but of course I was still in shock and just following instructions. Fine, a biopsy of my spine, just tell me when and I’ll be there.

With this, we left for a weekend in Boston so that my daughter could look at colleges. I was in a stupor and still fighting with a miserable cough and a sore breast implant.

Upon my return, I received two calls. One call was from the radiologist at the hospital. Apparently, this “tumor” in my spine was way too tiny for him to biopsy. I don’t even think that you can really say it is a tumor. Maybe a lesion. Who knows? I have since had a bone scan and there is no bone cancer. Major misdiagnosis. I also received a call from my original breast surgeon, who was enraged with all of this. He told me the breast cancer that I had does not do this and that whatever was in my lungs was most likely not cancer. He named several other things that it could be and for the first time, we learned that cancer cannot be diagnosed from a CATSCAN. You mean, I might not be dying?? What a novel idea.

With this, I went to my cosmetic surgeon for a checkup. To her great dismay, she discovered that the implant was trying to escape – a very unusual occurrence. I knew that I had been steadily coughing it out, but of course, nobody listens to me. Nevertheless, I was told to lie flat on my back until we could determine if the implant could be saved. All further oncologist appointments were postponed. For almost 2 months I lay here on my back, thinking that I was probably dying while coughing my brains out, in an effort to save an implant that wasn’t going to do me much good if, indeed, I had bilateral lung cancer. Ann, please stop me at any point and help me to make sense out of this. Are these guys entirely insane?

So, the weeks are going by and I am getting better and better. Even lying on my back, with the help of acupuncture and my naturopathic physician, the cough was clearing up. This, I strongly suspected, was not the pattern for lung cancer. Still, nobody would listen to me (except the naturopathic community), and nobody would acknowledge the written side effects of the drug I had been taking. The new oncologist that I was now seeing (how could the other oncologist have given me a 70/30 chance to live when he didn’t even know if I had cancer and if I did have cancer, what type of cancer did I have?) only wanted a lung biopsy. Apparently the CATSCAN was pretty ugly. This new and improved oncologist admitted that he had no idea what was in my lungs, but whatever was there, there was a lot of it and he wanted it biopsied. I begged to differ. The bottoms of both of my lungs had been under water all summer. Most likely there were stalactites and stalagmites growing in there. The point is that I was getting better, had just experienced a surgery gone wrong and a week in ICU. There was no way anybody was going to touch this body again! If my lungs were filled with that much cancer, I should be exhibiting some signs of illness, and other than a disappearing cough, I was fine. Nobody was listening to me and I was called a “naughty girl” for having an opinion.

So now it is almost Christmas. My breast continues to heal around the implant though at a painfully slow pace. We are waiting for fresh new skin that is strong enough to hold this water bag in place. I am still bandaged and haven’t had a shower since September. This whole experience has been so (pardon me) depressing, all because of an antidepressant drug that I shouldn’t have been on in the first place and should certainly not have been permitted to have surgery while taking. Can you say “drug interaction?” Jerks! I did submit to the bone scan, eventually, and all is well there. But my lungs continue to heal, I walk regularly, I am physically doing well and still they torment me with wanting a biopsy which I simply will not permit. It holds a risk of a collapsed lung – no big deal to them, but I think that I’ve had enough. I have only a small cough left, though I know that my lungs were injured by the Effexor and am waiting patiently for them to heal as best they can.

The effects of the original medication reaction are quite minimal at this point. I can take a walk, though I know that my muscles and ligaments are not normal and I have to watch not to overdo. They get sore. This is the first year, since the original reaction, that I can tolerate long sleeves. Up to this point, I couldn’t wear anything on my arms. They were extremely sensitive. My hands are permanently damaged, though fully functional. They are full of scar tissue from having been swollen for so long, and that renders them uncomfortable. My fingers have a bend to them and I can’t make a full fist. Otherwise, you wouldn’t know there was anything wrong. At a glance, they almost look normal. But they will never feel normal again, and that is unfortunate.

At this point, I am hoping to return to work in January – just 8 hours per week, but it’s a start. I am on no medication and never will be again. My psychiatrist refuses to inform the Drug Company that all of this happened. Without a biopsy, he refuses to draw any conclusions and I guess he assumes that this was all just a major coincidence. What a disappointment I will be to all of them when I get well.

Ann, this stuff has to come off the market. Humanity is not any more ready for this than it is for atomic weapons. I have now been victimized twice, not because of the medication itself (which is bad enough), but because the doctors refuse to acknowledge the side effects of the drugs even when they are tap-dancing in front of their own eyes. Personally, I have no idea how I will ever return to the care of any allopathic physician. For now, they appear to be the enemy.

Please keep me in your prayers and I will do the same for you.

Marge

Years 2000 and Prior

This is Survivor Story number 62.
Total number of stories in current database is 96

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Prozac, Effexor, Klonopin, Serzone, Zyprexa, Neurontin, and now Celexa-and Hospitalized Seven Times.

“I sometimes am so sorry I started him on this medication journey,”

 

I have had thoughts that maybe my son’s suicide attempts were related to the Prozac and other medications that he had been taking, and now after reading correspondence from others regarding the same behaviors, I am more convinced that there was a relationship between the taking of the drug and his actions.

My son who is now 26 years old has had problems with depression probably since he was l3. He got through high school but did very poorly, and became very depressed when he graduated because he felt he had no future. At that time, I took him to see a psychiatrist who put him on Prozac, but it did not seem to help him that much. I think she tried him on Zoloft also which did not seem to help him either.

He obtained a job at a shoe store working for a very nice family who liked him and who he enjoyed working for. He stopped the drugs and seeing the psychiatrist who said my son was an enigma. He worked at the store for 5 years, but one day abruptly quit. He then worked as a security guard for approximately a year and quit that job also. He decided to go to dog grooming school, and I’ll never forget his face the day he came home from school so proud and happy that he found something to do that he liked.

He did very well at the school, but started to have panic attacks. I took him to a psychiatrist again and she put him on Prozac and Xanax. He seemed to come alive, extremely talkative, and he finally met a girl and fell deeply in love. He then seemed to have problems with his mood lowering and becoming more depressed and anxious, so the psychiatrist increased the Prozac. I noticed at this time that his behavior was worrisome. Well the girl broke up with him and he tried to kill himself.

In the hospital they changed his meds to Effexor and Klonopin, he got out of the hospital and thought the girl might come back, but when he realized two weeks later that she wasn’t, He left in the middle of the night again, and eventually checked himself into the hospital after overdosing. He was sent to another facility after this and they put him back on Prozac. He attempted suicide again by overdosing. Altogether, he was hospitalized approximately 7 different times, with four of those being for suicide attempts. The last one being a year ago. Since then he has been on Serzone, Zyprexa, Neurontin, and within the last few months Celexa was added to this. He does seem to be somewhat better, but very flat, little conversation, rarely smiling. I sometimes am so sorry I started him on this medication journey.

I wonder if he would have been better off trying to cope with his low-grade depression, and maybe just taking an anti-anxiety medication for the panic attacks. I wonder.

Years 2000 and Prior

This is Survivor Story number 54.
Total number of stories in current database is 96

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