Monday, September 11, 2006

Some antidepressants raise violence risk

Tuesday Sep 12 10:56 AEST

New antidepressants, already suspected of increasing the risk of suicide, may also cause a few people to become violent, researchers reported.

They found that people who took GlaxoSmithKline's (GSK) antidepressant Paxil were twice as likely to have what was called a "hostility event" as those given a placebo.

Paxil, known generically as paroxetine, is in a class of drugs called selective serotonin re-uptake inhibitors (SSRIs).

They came under scrutiny when some doctors reported that teenagers taking the drugs might be more likely to commit suicide.

In 2004, the US Food and Drug Administration (FDA) concluded there was a higher risk of suicidal behaviour among children and teenagers and ordered strong label warnings on several SSRI drugs. It has urged close monitoring of adults.

David Healy and David Menkes from Cardiff University in Britain, and Andrew Herxheimer from the Cochrane Centre, used several sources of information to see what the risk of violent behaviour was among people taking SSRIs.

They looked at data on paroxetine presented by GSK to Britain's Committee on Safety of Medicines, legal cases and emails from 1,374 patients in response to a British television program on the subject.

They found that 60 out of 9,219 people who took Paxil or 0.65 per cent, had "a hostility event," compared to 20 of 6,455 given a placebo, or 0.31 per cent.
Writing in the online journal Public Library of Science-Medicine, the researchers said, however, that such violence was likely to be rare.

"The new issues highlighted by these cases need urgent examination jointly by jurists and psychiatrists in all countries where antidepressants are widely used," they wrote.

"When violence is a suspected outcome, every case has to be considered carefully, on the principle that individuals are responsible for their conduct, unless there is clear evidence of compromised function that cannot be otherwise explained."

Sunday, August 21, 2005

Weight Gain From Antidepressants, How to Lose it

Weight Gain and How to Lose It

If you are like most people fighting weight gain, you have probably tried several diets or several methods to lose the weight. The information below is not a guarantee that you will lose weight. This is a very difficult problem to overcome when weight is brought on due to psychotropic medication. I do feel there is now an answer for a VERY high percentage of people.
This Web Site was the first to bring to the public, information about weight gain and psychotropic medication. I had received thousands of e-mails from people stating they had massive weight gain after starting a psychotropic medication.
In 2005, the medical community has finally acknowledged the unexplained weight gain associated with these medications.
In 2001, this site began recommending Omega 3 for weight loss caused by psychotropic medications.
The results were around a 50% success rate. It was not until a clinical trial was released during the fall of 2004 that the percentages made sense. Roughly 34% of the population has a variation in the gene that metabolizes Omega 3.
The variation in this gene is a benefit for people with it, if they take Omega 3.
The people that lost weight with Omega 3 lost around 3-4 pounds per month.
During the spring of 2005, a book of mine was published titled The Road Back - How to get Off Drugs Safely.
This has allowed me to receive more detailed information from people and their physicians with changes that took place during the withdrawal process.
One thing that came up continually from people that had gained 50 to 60 pounds after using psychotropic medication is: this unexplained weight began falling off quickly. The weight loss occurred before reducing the medication.
The withdrawal methods in the book as well as the diet plan I will detail below keeps in mind all psychotropic medication and drug – supplement interactions. Especially cared for is the metabolic pathway used by medication to metabolize.
The Power Barley Formula below does not change the current taper program.
The products used for this weight loss program include:
Omega 3
Vitamin E
Global DNA Solution's Proprietary “Power Barley Formula”
How to Order Click here

As you can see Omega 3 and vitamin E is still a vital component of this weight loss program as well.

Working with Global DNA Solutions during the research process has provided invaluable information. I do thank them for their contributions.

What is in Each Product and Why They are Recommended

Omega 3 – Again, roughly 50% of the population will lose some weight with Omega 3 alone. Omega 3 in combination with Vitamin E and the Power Barley Formula is essential.
There is now ample research as well showing the benefits of Omega 3 for anxiety, depression or mood symptoms.

The importance of this specific Omega 3:
Pharmaceutical Grade - This process distills or cleans the toxins out of the oil. With all of the contaminates found in the oceans this day and age, it is vital that you do not put more toxins into your body. This Omega 3 is obtained from carefully selected fish oils. All of the raw oil is stringently tested for pesticides, PCB, and heavy metal contamination.

Serving size is rated with 3 softgels. The Omega 3 fatty acids are 2,714 mg per serving. 1,548 mg EPA and 828 mg DHA.It is the EPA and DHA that are important with any Omega 3.
There are 100 softgels with each bottle.

With an Omega 3 of this grade, the likelihood of you getting the results you desire at a lower dosage is increased dramatically.

Once you compare other Omega 3's, look at their price per softgel and the amount of EPA and DHA found in their Omega 3, you will find this brand to also be price competitive.An example: 100 softgels of a leading brand is sold at $12.95. Each softgel only contains 120 mg of EPA and DHA. To get the same amount of EPA and DHA you would need to take at least 5 times more and you still do not have a Pharmaceutical Grade Omega 3.

Vitamin E is needed for two reasons. Vitamin E needs to be taken daily if a person is taking Omega 3. Also, the Global DNA Solutions product contains gluten free barley that is rich in Selenium. Selenium requires Vitamin E to be the most effective. The Vitamin E recommended is 200 i.u. daily.

Power Barley Formula
Organic Barley Green – A USDA 100% Organic Barley. The organic barley green is 33:1 which gives the most pure form of barley green on the market today.
Organic Carrot Juice – The carrot juice is certified organic by Quality Assurance International.
Aktivated Barley – Aktivated Barley is certified by the USDA 100% organic.
Power Barley Formula Nutrition Facts
Based on 1 Tablespoon Serving Size % 30 Servings per Container Calories 25

Total Fat
0%

Saturated Fat
0%

Cholesterol
0%

Sodium
0%

Potassium
4%

Total Carbohydrates
2%

Dietary Fiber
8.1%

Sugar
1 gm

Protein
1 gm

Vitamin A
80%

Vitamin C
15.1%

Calcium
0%

Vitamin K
270%

Niacin
2%

Folate
8%

Phosphorus
2%

Selenium
4%

Iron
10%

Riboflavin
4%

Vitamin B6
4%

Vitamin B12
15%

Iodine
4%

Manganese
15%

The above is based on a the recommended daily requirement and a 2,000 calorie a day diet

How to Order Click here

Aktivated Barley is a pre-sprouted barley powder. This is the type of barley used by the Greeks and Romans in the Gladiator days. A little trivia for you: The original definition of the word Gladiator is “Men who eat barley.”

The above mixture was not originally intended for as weight loss product. This products sole purpose was for people to use during a withdrawal off psychotropic medication and to reduce or eliminate withdrawal side effects.

The weight loss success was not fully expected.

How to Use These Products For Weight Loss

Week 1
Omega 3 – Take 1 capsule around noon.
Vitamin E – Take 1 capsule in the morning
Power Barley Formula – Take 1 tablespoon in the morning ½ hour before breakfast.

Week 2
Omega 3 – Take 1 capsule in the morning and 1 capsule around noon
Vitamin E – Take 1 capsule in the morning
Power Barley Formula – Take 1 tablespoon in the morning before breakfast and 1 tablespoon ½ hour before lunch.

Week 3 and beyond
Omega 3 – Take 1 capsule in the morning, 1 capsule at noon and 1 capsule in the late afternoon but before 4 pm.
Vitamin E – Take 1 capsule in the morning
Power Barley Formula – Take 1 tablespoon in the morning ½ hour before breakfast, 1 tablespoon ½ hour before lunch, and 1 tablespoon ½ hour before dinner.

If during week 1 or 2 you lose 3 to 4 pounds, keep the diet program the same. Do not increase anything.

If you need more help from the supplements to lose weight, on week 4 you can increase the Omega 3. A few people that were taking 6 capsules of Omega 3 daily during the taper did begin to lose weight at that dosage.

I do not recommend you increase the Vitamin E or the Power Barley Formula any higher than what is outlined for week 3.

How to mix the Power Barley Formula

I suggest you use a rubber bottle, like a sport drink bottle, and fill it with 12 to 16 ounces of water. Put the desired amount of Power Barley Formula inside and shake a little, then drink. This makes it very easy to mix.

You do need to drink the Power Barley Formula within 30 minutes after putting in water.
You can mix the Power Barley Formula in apple juice as well. 8 ounces of apple juice with the Power Barley Formula is fine.

Do not mix the Power Barley Formula with an acidic drink or juice.
The Power Barley Formula has a semi sweet taste as well. The organic carrot juice is the item that created this nice taste.

How to Order Click here

Exercise – Many of you already exercise and have found it has not stopped the weight gain. However, this time it should be different! Having the right nutrients in the body with mild to moderate exercise will promote weight loss. If you can walk for 30 minutes a day or any type of exercise that will get your heart rate up for 30 minutes a day will help.

Foods to Eat – Based on the populations general DNA and the percentage of people with specific variations in their genes: I recommend the following types of foods.

Wheat or whole grain bread instead of white bread
Easy on the pasta
Eat brown rice instead of white rice when possible
Try and eat plenty of vegetables of all types (Steamed)
Do not eat or drink grapefruit
Cut back or eliminate charcoal cooked foods
Don’t over do it on red meats
Reduce milk to no more than 1 cup a day

If you are craving a pizza, have one. If you are craving chocolate have some. If you are craving any food you know is not good for you, have it.

The idea is not to suffer while you lose weight. You do not need to totally deny yourself or your body!

What has been found is: People that ate the foods that tend to cause weight gain, did not gain weight with this program.

What you can do if you are craving sweet or other types of foods that you really do not want to eat is to mix 1 teaspoon of the Power Barley Formula in water and drink. It helps take the chocolate cravings a way.

The Power Barley Formula helps balance your body PH level. Most chocolate cravings come from being too acidic in the mouth.

Make sure you consult with your physician before starting ay type of diet.

How to Order all of the recommended products for weight loss.

LMS distributes all of the products listed with this weight loss program. You can order all by calling LMS toll free at 1-866-628-6135 or click here to order online.

Omega 3 - Omega 3 and fatty acids are the basic building block of which fats and oils are composed. Contrary to popular myth, the body does need fat. It must be the right kind, however.

The purity of the Omega 3 is vital as well as the amount of EPA, DHA and long-chain fatty acids. The Omega 3 we recommend has the highest source plus is a pharmaceutical grade Omega 3 for purity.

Pure Omega-3
1 softgel (1200 mg)
3 softgels (3600 mg)
Eicosapentaenoic acid (EPA)
516 mg
1548 mg
Docosahexanoic acid (DHA)
276 mg
828 mg
Other Omega-3 Fatty Acids
113 mg
338 mg
Total Omega-3 Fatty Acids
905 mg
2714 mg

Produced from a patented, state of the art, solvent-free distillation process
Cholesterol Free - and No Saturated Fatty Acids.

Toxin Free - Obtained from carefully selected oils previously checked before processing for 0% pesticide, PCB & heavy metal contamination.

100% free of any toxic organic solvent residues or impurities.
Fortified with Vitamin E to protect the molecular integrity of the purified fish oil.
Deodorized so no fishy "repeats".

High grade fish oil starts with thermally fractionated health-food grade fish oil that is then distilled by highly complex refining technology into fractions rich in long-chain omega-3 fatty acids that are exceptionally low in the long-chain monoenes (that cause gastric distress) and pollutants - such as PCB's and oxidized and polymerized lipids. The individual fractions are then combined to provide a balance of EPA and DHA in the finished oil. The typical 1200mg capsule of pharmaceutical-grade fish oil will have 720mg or more of long-chain omega-3 fatty acids, but Pure Omega 3 is so advanced that it contains over 900mg of omega-3 fatty acids. This purity is reflected in a dramatically improved taste profile.

Sufficient levels of EPA are difficult to achieve on a daily basis unless one eats significant amounts of cold water fish such as salmon or consumes cod liver oil. Unfortunately, oils found in fish or commercial cod liver preparations may be contaminated with various toxic materials such as PCBs.

Scientific interest in Omega-3 fatty acids and fish oils increased greatly when it was realized that population groups who consumed fatty fish had considerably lower mortality rates from cardiac and circulatory diseases than the general population. It was determined that the oils in these fish provided the beneficial effects. Over 5000 scientific papers have been published dealing with and documenting the benefits of Omega-3 activated fish oils.

The two most important Omega-3 fatty acids are the biologically activated oils - EPA and DHA. EPA is effective in supporting healthy cardiac and circulatory systems, while DHA is an essential structural component of the central nervous system. DHA is important for optimum development of the brain and the eyes, and is therefore very important for the health of pregnant women and small children. Currently, the level of DHA in American women's breast milk is one of the lowest in the world.

Pure Omega-3 Pharmaceutical Grade Fish Oil gelcaps contain more than three times the EPA/DHA compared to ZonePerfect Omega-3 Fish Oil.

An independent panel of recognized experts has determined by scientific procedures that the fish oil used in Pure Omega 3 is GRAS (Generally Recognized As Safe).

Pure Omega 3 is deodorized and has excellent organoleptic characteristics - which means it has remarkably little smell or taste. In fact, it is so clean tasting that the softgels may be opened and the oil can be added to an adult's or child's food. However, caution must be applied when supplementing children with high EPA fish oil as it may prolong blood-clotting times. Please check with your doctor first. Add it to foods or a beverage immediately prior to consuming. Do not heat the oil.

Organic Barley Green –
Dr. Yoshahide Hagiwara first popularized dried barley green juice in the late 1980’s. His maltodextrin-based method of drying the juice into powder was the only option available for many years. Now technology allows us to offer the world's finest, 100% pure barley juice extract without any binders, fillers or preservatives. Pure Barley™ is grown in pristine fields and watered with mineral springs to ensure it has nature’s maximum nutritional input. If you use a green barley product and want the finest quality at the lowest price, Pure Barley™ is going to be your choice. Pure Barley™ powder is available in a bulk family size only (240 grams). Compare and save!

Organic Barley Grass Juice: Barley leaves contain all the vitamins, minerals, and proteins necessary for the human diet, plus chlorophyll, which is easily assimilated throughout the digestive tract, giving our bodies instant access to vital nutrients.
As a source of nourishment, barley is a complete food containing over 80 nutritional elements including all known vitamins and proteins. People with wheat allergies, by the way, have nothing to fear from this food.

Although barley is grown from grain, it has completely transformed into a vegetable with none of the allergic proteins common to glutinous grains.

Barley is non-toxic at any dose, but you may have a reaction to it because it is a potent detoxifying agent. Barley is a powerful liver purge and too much can release too many poisons, too fast. It also cleanses and heals the large intestine, another collection point of toxins in the body. But it is, perhaps most famous for its blood purification.

Grass is one of the planet's richest sources of high quality chlorophyll. Chlorophyll is liquid sunshine made by green plants. Sunlight charges and excites electrons in the chloroplast cells which then store that energy as ATP (adenosine triphosphate). ATP converts carbon and water into carbohydrates and releases oxygen into the atmosphere.
Ultimately, all food on the planet, whether animal or vegetable, directly or indirectly comes from chlorophyll. Scientists would love to duplicate photosynthesis, because it would provide an endless source of food and energy.

But even more amazing is that this "blood of plants" is a chemical cousin to hemin. Hemin is part of hemoglobin, the red iron rich oxygen carrying portion of human blood. Barley juice literally gives you a sunshine transfusion. When you drink it, this enzyme-rich and metabolically active fresh living food, transfers its high vibration to your system, raises your "kundalini" or "chi" and gives you a natural high. It is this energetic lift that enhances your ability to heal.

Carrot Juice –
Carrot juice is one of the richest sources of vitamin A that can be used in the daily diet. It also ranks high as a source of the other vitamins, especially those of the B complex. Its mineral content is equally rich, and includes calcium, copper, magnesium, potassium, sodium, phosphorus, chlorine, sulfur, and iron.

Thursday, July 07, 2005

Zyprexa Side Effects

Also visit http://www.prozactruth.com/zyprexa.htm for more stories.

HOSPITALIZED 6 WEEKS 104-105 FEVER STIFF, TREMORS, CATATONIC CURRENTLY RECOVERING HOSP 12-30 THRU TODAY 2-14

Zyprexa

I have been taking zyperxa for awhile now and i hear on tv about vioxx and this other drug and was wondering what was going on the doctor found that i had a tumor that had taken over my whole kidney and i had to have it removed while in the hospital i had a small heart attack and we arent sure if my body just couldnt tolerate the morphine or if its connected to zyprexa,i also take buspar and have been hearing things about that now saying that it shouldnt be given to people with seziuers which i have so i dont know what i should do as i cant afford an attorney on my own so i hope someone can be of help.

Zyprexa

My son is ADHD and was given this as a help.. the Strattera was not working.. He has been on for one week and we will be headed back to the dr. for a check up

Zyprexa

extreme confusion regarding movement of limbs; head bobbing and grimacing.

Zyprexa

zyprexa- doctor insisted it would work. i told him how horrible it was. he kept telling me it would get better to keep taking it. I would lie motionless for 6-8 hours and have no control. Like i was tranqualized. I asked him if it was ok to do my normal daily bike rides and he said it was ok even though the meds said to not do extensive exercise. i would get severe cramps. it was like lactic acid was tripled in my muscles. I didn't even feel safe driving to classes since i felt so drugged. I kept waiting for the "better" the doc was talking about. I always knew this wasn't good.I also am worried about the diabetes affect. I don't know if I should get checked out or not....

Zyprexa

My son is schizoaffective and while he was taking Zyprexa his heart rate jumped up to the dangerous zone, 120/110 Yet, none of the doctors will listen to me. We have ahistory of cardiac issues in both sides of the family.

Zyprexa

My mom was in a nursing home for a little over a month. While there she fell hit her head and had to be rush to the hospital. While at the hospital she suffered a minor stoke. All this after having a brain anerysum and taking zyprexa.

Zyprexa

I twitch a lot and my memory is gone, also I've gained 15 pounds!

Zyprexa

mask like expression, rigid walk, drowsiness

Zyprexa

my problems may be linked to zyprexa. I have taken it for probably 2 years now. I shake very bad. My kids give me a hard time about how bad I shake and cannot do things. I am only 46 years old. I also have some balance problems. Not severe but some noticeable when I first rise and begin to walk I do not often walk straight.

Zyprexa

I believe I got Diabetes from using Zyprexa.

Zyprexa

I am a 47 year old woman. I was placed on Zyprexa four years ago and recently discovered that there are many side effects to this drug and that it could cause diabetes. I was advised to stop taking this drug so I did however was not tapered off of it properly by New Hope Guild where I was going for therapy for so many years. I asked my therapist who had given me this drug and why it was given in the first place because nothing was explained to me when I was given it. I assumed it was just a regular anti depressant and it would be safe. None of the side effects were explained and the reason why I was placed on it was not explained. I do not remember the woman who placed me on this medication and had asked new hope guild to release this information and I was told they do not know why I was placed on it and they didnt know who gave me this medication. I'm assuming that is their way of covering themselves. TO make a long story short I went off zyprexa and developed pvc. Prematur!e Heart beats and am now having a lot of muscular and stomache pains in addition to back pains. I've been to many hospitals and doctors and explained the situation concerning zyprexa and it seems that noone of them want to deal with it because of the lawsuit possibility so they are all telling me that I hvae different problems however not giving a reason why I would and they refuse to discuss the zyprexa. I've had no luck so far and dont know if my situation will be getting worse. I have lost so much weight in such a small amount of time. I went from 225lbs to 180lbs in a matter of two months and am continuing to lose weight. I'm very depressed and have lost my appetite. I'm not the same person I once was.

Zyprexa

My 12 year old son has multable diagnoses. He is and has been on several meds which started at 3yrs. of age. He was on Zyprexa for over a year and is now being treated for borderline hyperglycemia which is being controled by diet. He can't have sugar, fruit,juice. Is to have low carbs and veggies. I'm told it is CRITICAL that he not gain 1 more pound. Tremmors.

Zyprexa

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Wednesday, July 06, 2005

Zoloft Side Effects

My doctor decided that I had been on Diazepam too long - 29 years at 10 mg. He said that there are safer alternatives on the market. Paxil did not do anything at all for me and when switched to Zoloft, I had vivid dreams about negative events which I remembered well into the day. During the day i found myself dwelling on every thing I had done in the past that I regretted doing. I quit Zoloft cold turkey and went back to diazepam. Within 3-4 days I was back to myself but a lot wiser about Zoloft. During my 1 year taking these drugs, i started my old teeth grinding behavior and clenching of the jaws at night. I also had muscle tension headaches caused by muscle constriction in the neck and shoulders.

Next

Zoloft - on and off for over 5 years. impossible to lose weight, heart palpitations, insomnia; tried to wean myself off it a year ago, had to go back on due to crying jags and irritability; am now down to 25mg every other day - feel a little dizzy, night sweats, EXTREME insomnia, but am going to tough it out. this drug helped me when I needed it, but made things worse in the long run. good riddance!

Next

I am not perscribed to take zoloft. i took 200mg recreationally. i also had a allergic reaction to it. i couldnt breathe the next day. i took it the night before around 12 am. it hit me the next day around 530 pm. my tongue got numb and so did my throat. and i felt this sensation run through my body. it was the worst feeling in my life. it lasted all night. i felt like shit the next morning. i couldnt breathe worth shit. so i admitted my self to the ER. they checked me out did a chest exam and said i was fine. they told me i was having lung spasms. the next day i felt fine and then the day after i started having anxiety attacks. just out of no where they come and i just feel immobilized. its been a week now since i took it and i still have side effects. i have had 60% of the side effects shown for a overdose. i just wanna know how long this shit is gonna last.

Next

I was taking Zoloft for about two and a half years after I turned 18. I had clinical depression and things seemed to be better when I was taking it but I have been grinding and clenching my teeth sense I first started it. When I had to take myself off of it I went into a complete nose dive, I thought my world was coming to an end. I would burst into tears at work and eventually had to change to part time hours. About six months before I stopped taking it I started to get horrible sexual side effects. I had pain durring intercorse and most of the time never even had the urge to be sexual at all. My doctors think it's all in my head and tell me I should go to a therapist.

Next

I was taking 50 mg, but I was breaking 100's in half. I was nauseaous alot, espically in the morning, I took my pill at night. I had extreme insomnia, to the point of 4am being a resonable time for me to fall asleep. The funny part was I was not totally wasted all day, barely tired. Since I have stopped, about a month ago now, I cannot even have ONE drink, without a terrible hangover, and I can't taste the alcohol either.

Next

There has been a history of depression in my family for a long period of time. My grandparents, my mom and now myself. My mom is on several different anti- depressents and none of them honestly seem to help her much. My self I have taken Paxil and now Zoloft. I started taking Paxil not for depression but for the horriable anxiety attacks I used to have. I was doing well taking the 12.5 Paxil but eventually went through much emotional distress and the doctor decided to increase my medication to 25 from the origional 12.5 . Paxil was the only medication that I was taking at the time and within less than one week of the increased dosage I started seeing severe bruising on my legs and they were swollen most of the time. None of which was "normal" for me. I became quite concerned and called my doctor. She did some blood work and found that my Potassium level was extremely high and couldn't explain why.

Next

I have been taking zoloft for 3-half years.I have problems with my memorie,and focusing on everyday things.This is not living!I am suicidal when I do not take these pills!Slowly but surely I am losing more than just my mind.I have already lost my car, my job,and friends.I want to get off of this stuff.I want to smack my doctor!!!

Next

My daughter and I are crying ( happy cry and afraid) She has been on Zoloft 100mg for 5 months. Has had severe diarrhea, I am talking severe. She just went through a colonoscopy, gastroscope--WE ASKED ALL THE DOCTOORS IF IT COULD BE THE ZOLOFT__THEY ALL WERE CLUELESS. thank God for this web site!!! we are pretty much hysterical right now, because she took a pill tonight and THEN we started reading this tonight. My daguhter is frightened. Please write us. Gail and Addy PS We will be reporting these symptoms to the FDA---diarrhea--severe---tingling in extremiites, nightmeres, night sweats and finally--severe vomiting--vision problems!!

Next

While I was on Zoloft, my depression lifted for a short time, but then I was plummeted into it once again. This time, it was worse. I would still cry all the time, and I noticed this empty feeling in the back of my head. When I was sitting in church one night, I just fell apart. My boyfriend broke up with me because he couldn't understand what was going on. I thought about suicide all the time, and even attempted it once or twice. Zoloft seriously turned me into a person I didn't want to be. It ruined my love life, and even though it did help me at first, it did come very close to making things all the worse. After 8 months, I stopped cold turkey, and never regretted it. I've had to make changes in my life, and unfortunately, I must now admit to people that I was once suicidal, even though I didn't know and still don't know why. I have also finally managed to overcome the depression that got me on Zoloft in the first place. Even though I'm only 17 years old, and took this dr!ug when I was 15, I recommend that anyone experiencing symptoms of depression find someone to talk to, and stay as far away from anti-depressants for as long as possible.

Next

I was on zoloft for 8 months and felt a little too foggy and nonchalant about things so i slowly went off which caused rapid heartbeat and skipped beats - it was terrifying and i actually had to be on a heart monitor for a couple days.

Next

They say I have Post Traumatic Stress Syndrome. I have always been emotional but even my therapist says for the abuse i've suffered by my mother, I should be into drugs, etc. Funny thing is, they want me to be on Zoloft! I'm resisting because I managed to come this far & do very well. I"m just very emotional & not joyful sometimes... but i'd rather make it through those days then take Zoloft. Thank you brave tesimonials. You have given me strength to say NO.

Next

Recently came off zoloft after 1year,it did help numb my anxiaty, but left me with no feelings, apathy and no sex drive.I went on half doze for a wesk, then stooped, my sex drive came back quick, but I am so anxious, talking all the time and no concentration, really know feel I shouls of never taken it. Its been 3 wks, beginning to feel more normal, but social asnxiaty is worse.

Next

i was put on Zoloft after a divorce, only been on for 4 weeks and I feel awful, nightmares, developed subacute hyperthyroid(and I am in good shape and eat well), feel tired and a littlel crazy all the time. I stopped taking it 3 days ago. Hopefully I'll begin to feel "just depressed" soon. That's a whole lot better than this!!!

Next

I have been on zoloft now for about four years. At firstThey gave me a feeling of well-being but that was very short lived. I have tried coming off them a few times now and each time is a nightmare. FEELINGS OF PANIC AND NOT WANTING TO LIVE, FEELING LIKE i'M GOING ABSOLUTELY CRAZY. i WANT SO BADLY TO GET THIS CRAP OUT OF MY BODY, BUT i JUST DON'T see how - I think I would have to be hospitalised and sedated. I want to be able to think clearly and feel real feelings again. I hate this stuff. It has ruined my life.

Next

Since my doctors put me on Zoloft (they didn't even warn me or my mom of the side effects) I have been having horrible nightmares that usually resulted in screamings that could be heard throughout the house while i slept. I've been having severe lower back pain at times, to the point it was excruciating to bend down. I also been having pain when urinating.I used to be very shy, but now I scream at people from out my car window, make faces at them, and even throw things at people when taking a drive with my mother. I am now known by my whole family to laugh at the most inappropriate times, and say the most random and strangest things. I find it very difficult to concentrate on my school work, and never get anything done. I sleep strange hours, usually during the day now. I sometimes sleep for 12 hours. I have gained almost twenty pounds, and my mood swings got worse. When I don't take my medications i feel suicidally depressed, and now try not to miss taking them out of fear!. I have strange cravings for sweets, and sometimes won't eat anything else until I get to eat something sweet. I am scaring my whole family and myself. The only 'good' thing Zoloft did was stop my shyness, but that aint really a good thing seeing now I do the most craziest things in public, and can't seem to no what's right and wrong to do in front of others.

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I have only been taking this medication for 3 days and I already am feeling all of these side effects which are not listed in the "sample pack" that I was given by the doctor. To be honest, it really worries me when pharmaceutical companies even offer sample packs because it tells me they need to try to sell their meidcation, rather than it just being taken by those who need it. So, my doctor gave it to me, along with some Xanax (which I requested) because of some serious anxiety that I've been going through in trying to finish my thesis. I told her that I didn't want to take it because I already have GI sensitivities, but she assured me it would help. Well, I started making a list of side effects that weren't on the pamphlet or on webMD. Then I did a google search and found this site, and I swear ALL of my extra list side effects were the ones listed here. I know my body, and trust my intuitions about it, and I had pretty much already decided to stop tsking it, but this jus!t affirmed my faith. I think it's important for people to realize that you DO know your body, and you SHOULD trust your feelings. If you think it's the medication. Tell your doctor you want to stop it, and will do it with or without them. It's a very sad statement for the current state of Western medicine. thanks so much for this site!!!

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I've been on Zoloft for about a month now, and I'm not sure how I feel about it. It definately creates a zombie like feeling, but it's a pretty content one. I don't feel like myself, but I feel pretty happy. It decreases nervousness and inhibitions, and I've done some pretty stupid things on it b/c I just wasn't afraid or didn't care what happened to me. I don't feel like a genuine person with genuine emotions, and I get very bored w/ myself and I feel like other people notice the "emptiness" some. I also have had extreme headaches with it, horrible itchy dry patches, bumbs that swell up on my head, breast and hip growth, decrease in muscle tone, suicidal thoughts and increased energy as side effects. I think I'm going to go off it though b/c I don't really feel like myself or like I'm really living. It's kind of like being in a little dreamworld floating around...really weird.

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I went to a new doctor at GBMC in March 2005 and have suffered from anxiety and related blood pressure problems for a while. The doctor recommended that I change to Lotrel, a bp medicine and start taking Zoloft instead of xanax. He said xanax was habit forming. Let me tell you, if you think xanax is bad, and it is not, it is a safe medication actually, I found it out the hard way. Zoloft is a drug that in my opinion is right up there with Benecar and Lotrel. It should be taken off the market. The combination of taking these two medicines sent me to the hospital with terrible chest pain and thinking I was having a heart attack. It was a severe panic attack. The two drugs drove my blood pressure through the roof and put me in constant fear. Zoloft is not a good drug and it is not safe. All the bad things you have heard about it are true, even at the 25 mg dosage. I know I was on it long enough to know. I sometimes wonder if doctors really know what these drugs do t!o people. Needless to say I am now back on a low dose of xanax and Zestril for blood pressure and everything has returned to normal. I now have very little faith in this doctor and wonder why in the world he prescribed these medicines for me. I still have no answer. I don't believe he knew it was going to affect me this way. It scared me to death. Zoloft causes in a lot of people what it is designed to stop. My cousin was on it too and had bizarre dreams about Hillary Clinton and purple people and got off it immediately. Lotril, Benecar, and Zoloft, are all dangerous drugs even at a low dose and should not be used by people in my opinion. I don't know what the doctor was thinking and I am now seeking the advice of my old and reliable physician and my old medicines. It gave me a renewed appreciation for the doctor I had. A warning, just because it is a newer drug, does not mean it is a better one. Xanax at a low dose can be taken for years and not be habit formin!g, and the labels lie about Zoloft, there are lots of side effects wIt should be banned from the market.

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My ObGyn prescribed Zoloft when I was pregnant with my youngest child. I took it for about 6 months of my pregnancy. When she was born, I felt nothing for her. I was robbed of that joy with her. She was denied the bonding and love that she needed and deserved. I took care of her basic needs, but that was all. My husband said that I didn't seem to care about anything. I didn't feel happy or sad, just stuck in neutral. My mother-in-law is now on Zoloft and complaining of the same thing. I told her about my experiences, and we discovered things that we didn't even relate to Zoloft were indeed caused by it. After reading some of the stories here, I am afraid of what it has done to my daughter. She is now three and a half years old. She is bright, sweet, and loving but I worry about the future for her. I trusted my physician to do right by my child and me. I take no meds for my depression and social anxiety. I will NEVER take anything again. I would rather cry for! days on end than to feel nothing at all. I truly with that doctors and pharmaceutical companies cared more about people than the almighty dollar.

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Thank you, thank you, thank you! I thought I was going crazy before I read everyone's comments. I am experiencing 80% of the side effects listed by others. Mainly the weight gain in the last 2 months along with ringing in my ear, sweating and the energy loss. I was looking for answers and out of whim, I decided to do some research. I am going to take myself off Zoloft greadually since I am up to 200 mg at this point. By the way, I was given Zoloft for my migrane.

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I have been on Zoloft for about a year now. My doctor which me from Prozac to Zoloft when I got pregnant. While I was pregnant the Zoloft was working just fine. Now, 3 months after having my son and breastfeeding my doctor will not put me back on my Prozac. My Zoloft dosage has went from 50mg. to 100mg. to 75mg. I have good days and bad days. Sometimes I feel my depression and aniexty is worst than usual. I have no sex drive what so ever. I feel like I am losing my mind.

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I've been taking Zoloft now for 2 years and I have started getting unconrtolable tremors to my head.

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My 9 year old son was initially prescribed 12.5 mg. of Zoloft for depression. He seemed to be doing well, so his doctor upped his daily dosage to 25mg. about a week ago. Now, his school is seeing aggressive bahvior that has escalated since Feb.2005 (when he began the medication). Usually quiet and friendly, he has threatened to punch his teacher and guidance counselor, bring a gun to school, kicked doors and thrown dess, ripped up books and school displays. Highly unlike my son! At home, he has gotten increasingly disrespectful and rude. I phoned his doctor after a lengthy meeting at his school and was advised to immediately discontinue the zoloft. I am afraid, not of my son, but for my son. My intention was to help him. He has a Learning Disability, and his biological father suffered from manic depression. I knew that these factors really weighed in on him feeling despondent, and only sought to help him to feel like a normal 9 year old should-happy, interested in sports and! friends, video games, etc. This is not what I wanted for my child. I am highly upset, because I now feel like perhaps he feels as if he can't control his actions and I'm at fault for allowing his doctor to prescribe this dangerous drug.I hope this letter helps someone else in this situation to see the truth:this drug does more harm than good.

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I'm 25 years old and took Zoloft for around 6 months. I began taking Zoloft because I was mildly depressed. The first side effect I noticed was that I started to just not care about anything. I was letting everything around me go... my house was a HUGE mess... my kids were behaving like animals... I started gaining weight, I let my own and my kids apprearance completely go... I stopped volunteering for my kids activities... I stopped calling my family... I just stopped giving a crap about everything that had ever meant anything to me. I became forgetful and would sometimes even forget to feed my pets... I would forget to sign my kids school papers, and make sure they had their homework... I would miss appointments. I became very, very moody... to the point that my husband was coming home late every night from work just to avoid me and the chaos that was all around me. I felt tired all the time. No matter how much I slept or rested, I always felt like I was in the "!waking up" stage... Groggy and foggy. I knew there was a serious problem but was convinced that the Zoloft was helping me instead of hurting me. So I went back to the Dr. I then began taking Klonopin to deal with the anxiety that I had from all the chaos. Nothing around me was in any kind of order at all. It wasn't long before I started abusing the Klonopin, taking more than I should, again convinced that it was going to "fix everything". Then my close family decided it was time I go to the hospital... which we would later discover to have been the worse decsion we could have ever made. While in the hospital... I was increased to 100 mg a day of Zoloft... My Klonopin was increased, and I was put on Abilfiy after being told that I was bipolar. At first, I felt relieved to know what was wrong and started reading more and more about bipolar disorder. I thought things were going to get better... positive that my doctors were giving me the right medicines to make me "rig!ht". Things did not get better. My life went on a downward spiral.

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I haven't taken Zoloft for too long I was given it as a trial to see if it would help with my PMS after taking it just three times I felt like I was always moving when I wanted to sleep I couldn't and then out of no where I would sit down and fall asleep ( ifeel asleep in a elevator and a concert) I had a horrible ringing in my ears and I had the worst headache. It felt like someone was drilling into my skull. I now only take it every other day and they don't happen as much but they still happen.

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Hi from Australia. I took Zoloft for about 6 months or so for mild depression and severe PMT. Every doctor I talked to (3) tried to put me on Zoloft in the end I did so. . I was only on 25mg as I never went up to the full 50mg dose the Dr wanted I just kept cutting my pills in half and did not tell him. My side effects were. Weight gain (5kg) poor body temperature control -hot and cold easily, difficulty with orgasm, blood noses, funny heart beats, difficulty sleeping and going to sleep, strange and disturbing dreams and the big one MEMORY LOSS. I gradually took my self off by cutting the tablets into ¼ and then only every second day it took me about 3-4 months to get off completely as I was often feeling angry and irrational PMT or not. Gradually I got off and all symptoms have gone but the big one, I have NO memory still. I often forget which way to turn the tap on and off. I just try out all the light switches until I get the one I want. I have forgotten my !child was with me when I went out and left her behind. I do think this drug helped me get myself back together but at what cost?? I will have to live with this memory trouble for the rest of my life. I just hope I don’t hurt myself or anyone else because of my inability to remember things around me e.g. toast cooking. P.S all other symptoms went away once I stopped taking the drug PPS (see I forgot that I wrote this last sentence already in the letter) You have to laugh or you would cry.

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Hi I took Zoloft for about 6 months at the time I thought this was the best thing on earth for me as I had been suffering from severe PMT and mild depression because of this. The simptoms I had during the medicated period were as follows difficulty with orgasm, Very poor memory, blood noses, heart beating funny, mild difficulty getting to sleep, shorter sleeping periods, weight gain (about 5kg. I decided to take myself of this and attempted to cut my dose in half for a while then I went to every second day. I found I was very irritable and almost ewent back on but over a period of about another 6 months I finally got back to normal and am now far more aware of my PMT reactions and do not think myself mad. I do believe Zoloft was of some benefit to me but at what cost!! My memory has never returned to how it was. I have trouble concentrating on more than one thing at ta time. I find I have to re learn tasks almost everytime I have to do them as I have forgotten (eg si!mple things like which way the tap turns or which is the correct light switch. I have given up remembering important things like appointments. I have now been off Zoloft for over 2 years but I still have these memory issues I have accepted this as part of my life and anm trying to deal with it. If I had known that my memory would be so effected I would have tried every other option first before taking this drug. If I was about to jump off a cliff I would than perhaps go and take this drug but in the smallest dose possable.

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I too was prescribed Zoloft as soon as my doctor learned I engaged in self-injury, however minor and intermittent it was, I understand it was a problem. BUT, she did it within SECONDS of my telling her. Nothing else! I took it, not realizing just what I was getting into. I couldn't stay awake and had headaches every night at the time I took the pill. I was on a LOW dosage too! 50 mg. Then, I missed two doses, had a bit to drink one night and BAM...extreme anger and I ended up hurting myself badly! This was bad...so I stopped cold turkey. NOW...I feel worse than ever. I am dizzy all the time, always hot and nauseous, have headaches still and am SOOOO tired I can barely function. And I was only on this stuff for about a month or so! This is horrible and I WISH I had been warned more about what this medicine could do to me. Be careful what you take for ANYTHING, I say. I've never felt so bad in my life, physically speaking. I hope this goes AWAY...and soon!

Prime Time Internet News: Papers indicate firm knew possible Prozac suicide risk

Tuesday, January 04, 2005

Missing Prozac documents released.

You can read the missing Prozac clinical trials by clinking this link.

http://i.cnn.net/cnn/2005/images/01/03/eli.lilly.pdf

FDA Fighting for Corporations Instead of Public

Under the direction of Chief Counsel Daniel Troy, the first political appointee to hold the post, the Food and Drug Administration has been weighing in on state civil suits on behalf of drug companies and medical device manufacturers. What makes this particularly unusal is the fact that the court in these cases has not requested FDA's opinion; Mr. Troy is actively seeking out such cases and coordinating with defense counsel as to how the agency can best assist the corporations. This behavior runs completely contrary to the FDA's stated mission of protecting the public from being harmed by the food and drugs they consume.

Daniel Troy, Chief Counsel of the Food and Drug Administration, is taking the counsel's office in a wholly unprecedented direction, repeatedly interceding in civil suits on behalf of drug and medical device manufacturers that were accused of harming patients who had used their products. In doing so, Troy has worked in cooperation with the manufacturers, ignoring serious conflicts of interests. The FDA has attempted to mislead Congressman Hinchey in his efforts to look onto this matter.

BACKGROUNDOn August 20, 2001 President Bush appointed Daniel Troy to be Chief Counsel of the Food and Drug Administration. Previously, civil servants held this position. Troy was the first political appointee to the FDA post.
Congressman Hinchey has been following Mr. Troy's activities for several years now and has done extensive research and investigative work beginning in early 2004.

The FDA is the government agency charged with protecting the public by ensuring that foods are safe, wholesome, sanitary and properly labeled; and by ensuring that drugs and medical devices are safe and effective.
The FDA is failing in that mission in large part because of a radical new direction that Daniel Troy has taken FDA's Office of Chief Counsel, at the behest of the pharmaceutical industry.

RADICAL DEPARTUREFor the first time in FDA's history the FDA's Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which the FDA can intervene in support of drug and medical device manufacturers. The cases he is seeking out are private state civil litigation cases. These are cases in which in which drug companies and medical device manufacturers are being sued by people harmed by their products. The court has not asked for FDA involvement in these cases.

In other words, FDA is spending taxpayer dollars to defend drug companies who are being sued in state court. Since August 2001, the FDA has expended over 600 hours to file at least six briefs on behalf of these companies in four such cases across the country.

Mr. Troy is using the argument of preemption to shut down these cases before they can even begin and has stated that there is a well-documented precedent. Yet when Congressman Hinchey's office contacted several former FDA officials and Justice Department officials, not one had ever heard of such an action by the United States before Dan Troy came to power. Moreover, Mr. Troy's immediate predecessor stated clearly in 1997 that FDA long had a policy against preempting courts in this way. Explaining the reason for that policy she wrote, "Even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems presented by the product. ... Preemption of all such [tort liability] claims would result in the loss of a significant layer of consumer protection."

Legal scholars agree as well. Professor James O'Reilly from the University of Cincinnati Law School is one of the country's preeminent legal scholars on FDA issues. He is also acknowledged by the Supreme Court as an expert on FDA legal matters and is a former drug industry lawyer. Professor O'Reilly has stated that he knows of no precedent for FDA's actions.

In fact, in 1996, the United States argued before the Supreme Court that the private lawsuits Mr. Troy is seeking to kill should be allowed and are necessary to hold companies accountable for their actions (Medtronic v. Lohr). For Mr. Troy to now be arguing the opposite, and to do so without any precedent, is completely outside the bounds of normal jurisprudence.

The overwhelming response from Mr. Troy's fellow lawyers is that what he is doing represents a radical departure from past government efforts. Not one person Mr. Hinchey's office spoke with could identify anything remotely similar to what Troy is doing at FDA.

MASSIVE CONFLICTS OF INTERESTPrior to Mr. Troy's appointment to the FDA he was a partner at Wiley, Rein and Fielding - a large Washington, DC law firm. He was also involved with the Washington Legal Foundation, which is a "public interest" that supports weaker government regulations of drug companies and medical device manufacturers.

One of Mr. Troy's clients at Wiley, Rein was Pfizer, which in the three years prior to his appointment at FDA paid Wiley, Rein $415,000 for "services provided directly by" Mr. Troy.
In July of 2002 Malcolm Wheeler, an attorney for Pfizer, called Mr. Troy, then FDA's chief counsel, and requested that FDA get involved in a private state lawsuit against Pfizer that was ongoing in California. Mr. Troy obliged and in September, less than two months later, FDA, through the Department of Justice, filed a court brief in support of Pfizer.

That same July Mr. Troy also had a meeting with Michele Corash from Morrison and Foerster on "Proposition 65 issues." Morrison and Foerster, one of the world's largest firms, is based in California. At the time of this meeting, it was representing Glaxo Smith Kline in a private lawsuit in California that revolved around California's Proposition 65 or the Safe Drinking Water and Toxic Enforcement Act. Michele Corash was the lead attorney. On September 12, less than two months after that meeting, Mr. Troy's FDA filed a brief in support of Ms. Corash's client - GSK.

This pattern continued in 2003. On December 12, 2003 FDA filed a Statement of Interest in the case of Murphree v. Pacesetter in support of the medical device manufacturer Pacesetter. The company was being sued in Tennessee state court for a faulty pacemaker. Congressman Hinchey's office obtained a letter to FDA, dated November 25, 2003 from the law firm of Feldman, Gale and Weber directing FDA on how it should assist its case. The firm was representing Pacesetter.

In re Paxil is a fourth case in which FDA submitted an unsolicited. According to remarks by Mr. Troy, he involved FDA because he thought a California state judge's ruling in the case was "crazy."

What these few cases describe are massive conflicts of interest and a pattern of collusion between a federal agency and the industry it is supposed to regulate. If FDA did for some reason need to get involved in these cases, it should have done so independently of the drug companies, not in coordination with them. Mr. Troy is supposed to be acting to protect the public's health, not his former drug company clients. Instead, he is actively seeking opportunities to help the drug companies.

On December 15, 2003 Mr. Troy was the featured speaker at the 8th Annual Conference for In-House Counsel and Trial Attorneys, entitled "Drug And Medical Device Litigation." Conspicuously, this event was not noted on FDA's public calendar, which listed 44 other speeches Mr. Troy has delivered. The conference program uses his official title.

It seems unlikely that omission was accidental. According to a signed affidavit of a conference participant Mr. Troy took credit for FDA's involvement in private civil litigation cases and solicited cases in which the FDA could intercede. He told the audience "we can't afford to get involved in every case, we have to pick our shots," so "make it sound like a Hollywood pitch."

Mr. Troy also outlined his reason for getting involved in these cases: tort reform. He specifically stated that FDA is "deeply immersed in tort reform issues," and that it was FDA's goal to "control the flow of risk info regarding these [drug and medical device] products."

MISLEADING CONGRESSCongressman Hinchey raised this issue with acting-FDA Commissioner Lester Crawford when he testified before the House Appropriations Agriculture Subcommittee on March 11, 2003. He asked about Mr. Troy's relationship with Pfizer prior to his appointment. The answer FDA provided for the record sought to minimize that relationship. According to FDA, Mr. Troy worked an average of less than 80 hours per year on matters related to Pfizer. Congressman Hinchey later discovered that Pfizer paid Mr. Troy's law firm $415,000 over three years for work performed directly by Mr. Troy. This included over $358,000 in 2001, the year Mr. Troy was appointed to his FDA post.

On a bipartisan basis, the House Appropriations Committee included language written by Congressman Hinchey in the Agriculture Appropriations report, expressing concern about the misleading nature of FDA's answer.

Subsequently Hinchey uncovered additional evidence that FDA provided misleading or even false answers on the record.

In that same response, FDA asserted that Mr. Troy "became involved in a case affecting Pfizer more than a year after leaving private practice." According to press reports, however, Pfizer's lawyer contacted Mr. Troy in July of 2002 about his case, which was less than a year after Mr. Troy left his firm.

In response to another question Mr. Hinchey asked about FDA's history of involvement in these lawsuits, FDA again provided a misleading answer. The response sought to imply precedent for FDA actions by citing previous cases, failing to note that these cases were in response to court requests. None of the pre-Troy cases cited involved the FDA actively seeking to intervene in private lawsuits.

That same answer also failed to list two other lawsuits in which FDA filed briefs under Mr. Troy, unsolicied by the court.

And finally, in response to another question from Rep. Marcy Kaptur, FDA provided a list of cases and stated that those "that do not name the government (FDA, United States or HHS) are cases in which FDA has been subpoenaed to produce a witness or documents." This is simply false. There are at least four cases in which FDA got involved without being subpoenaed. Mr. Troy himself has even stated that he was "the initiator" of such cases.

These five instances of misleading or false answers in response to questions from members of Congress are deeply troubling and severely undermine the credibility of the FDA.

PEOPLE HARMED Over the last few months it has been widely reported that drug companies are providing the public and federal officials with less and less information about possible harmful side effects of their products. We know that these companies often do not share the results of clinical trials that demonstrate problems with their drugs. This has spurred the American Medical Association and the editors of several major medical journals to call for a public registry of all clinical trials for FDA-approved drugs.

The lawsuits that Mr. Troy is seeking to shut down have become the last line of defense to get that information and hold companies accountable for misleading consumers. With whistleblowers becoming more and more rare, most scandals involving consumer products are uncovered through lawsuits just like these. Our country has relied on them for decades to ensure that consumers have a remedy and an avenue to defend their interests.

ACTION TAKEN BY HINCHEY
On July 13, 2004, Congressman Hinchey offered an amendment to the Agriculture Appropriations bill, taking $500,000 away from FDA' Chief Counsel's office. In offering the amendment, Mr. Hinchey stated his intention that the funds be cut from FDA's Office of General Counsel, which is housed in the Commissioner's office, and added to FDA's Division of Drug Marketing, Advertising, and Communication, the office responsible for monitoring drug advertisements. The amendment was accepted without opposition.

Since then, Mr. Troy and FDA have sought to restore the funding. Mr. Troy has visited legislators on Capitol Hill, distributing a copy of a letter from five former FDA chief counsels. This letter has also been submitted to the Congressional Record to refute Congressman Hinchey's assertions. The letter contains several false claims.

Rep. Hinchey's argument is mischaracterized in the letter from the counsels, which reads in part, "Representative Hinchey states that Mr. Troy 'has taken the agency in a radical new direction' by submitting amicus curiae briefs in cases in which courts have been asked to require labeling for pharmaceutical products that conflicts with FDA decisions about appropriate labeling for those products." That is not what Rep. Hinchey has argued. The "radical new direction" refers to Mr. Troy's practice of soliciting lawyers for drug companies and medical device companies to come to him with cases in which to intervene; and submitting briefs in private civil cases in which FDA has not been asked for its opinion.

The letter then cites four examples of cases to show that in fact this type of activity on the part of the FDA predates Mr. Troy's term in office. None of the cases, however, provide such precedent.

Here's why:Weinberger v. Bentex: FDA had no choice but to file briefs since the agency was the defendant, not an intervener. Rep. Hinchey is arguing that the FDA never before intervened without being requested to do so.Jones v. Rath Packing: The FDA submitted a brief to the U.S. Supreme Court in a case involving a government agency and the labeling of flour. Again, far different from interceding in a state civil case between two private parties about product liability.Bernhardt v. Pfizer: The court requested FDA's statement of interest. Eli Lilly v. Marshall: According to the court's decision, FDA did not submit anything in this case and the case had nothing to do with product liability.

The former chief counsels wrote, "In none of these cases did any court request FDA's opinion. Thus, there is ample precedent for the actions that Mr. Troy has recently been undertaking. His action is not radical or even novel." That assertion is inaccurate.

Congressman Hinchey has written a letter to Acting Commissioner Crawford, requesting further documentaion in this matter. He has also written to Agriculture Appropriations Subcommittee Chairman Henry Bonilla to refute the claims of the former chief counsels.

Monday, January 03, 2005

Papers indicate firm knew possible Prozac suicide risk

(CNN) -- An internal document purportedly from Eli Lilly and Co. made public Monday appears to show that the drug maker had data more than 15 years ago showing that patients on its antidepressant Prozac were far more likely to attempt suicide and show hostility than were patients on other antidepressants and that the company attempted to minimize public awareness of the side effects.

The document was provided to CNN by the office of Rep. Maurice Hinchey, D-New York, who has called for tightening FDA regulations on drug safety.

"The case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks," he said.
The 1988 document indicated that 3.7 percent of patients attempted suicide while on the blockbuster drug, a rate more than 12 times that cited for any of four other commonly used antidepressants.

The document, which cited clinical trials of 14,198 patients on fluoxetine -- the generic name for Prozac -- also stated that 2.3 percent of users suffered psychotic depression while on the drug, more than double the next-highest rate of patients using another antidepressant.

In addition, the paper said that 1.6 percent of patients reported incidents of hostility -- more than double the rate reported by patients on any of four other commonly used antidepressants.
The trials reviewed in the document said that 0.8 percent of users of Prozac reported causing an intentional injury -- eight times the rate associated with any of the other antidepressants.

In the paper, titled "Activation and sedation in fluoxetine clinical trials," the authors said that the drug may produce nervousness, anxiety, agitation or insomnia in 19 percent of patients, and sedation in 13 percent of patients.

The paper, apparently produced by the drug company's marketing department, said "several suggestions may be helpful in presenting this information to physicians," including emphasizing that more patients on another class of antidepressants stopped taking their drugs than did those on Prozac.

The existence of the document obtained by CNN and other documents was reported last week by the British Medical Journal. Its editors said the documents had been reported missing from a 10-year-old murder case, and that they had sent them to the U.S. Food and Drug Administration for review.