I must say that I am very, very tired of seeing that damn Cymbalta commercial rambling on and on about how depression hurts and Cymbalta can help.  I think they need a different commercial.  How about this one?



What is Cymbalta?
Cymbalta is a brand-name for a drug called duloxetine, a dual uptake inhibitor. Cymbalta (duloxetine) is in a class of drugs known as SNRIs (Selective Serotonin/Norepinephrine Reuptake Inhibitors) (similar to SSRIs) and is an antidepressant that is used to treat depression and anxiety. Cymbalta has been linked to serious side effects including heart defects and persistent pulmonary hypertension in the newborn (PPHN) when Cymbalta is taken by the mothers during pregnancy.  Cymbalta haa a very short half-life causing severe withdrawal effects.

Eli-Lilly
Eli-Lilly, the makers of Cymbalta does not make the severe side effects of Cymbalta known to the public, nor the massive withdrawal effects. Doctors are not informed of the withdrawal effects, and it is something that showed up in trials prior to being released, and severe issues have been arising since, but Eli-Lilly does not make this readily available to the public.

Withdrawal
These withdrawal effects cause severe problems in more than half the users that try to come off the drug. Slow tapering helps somewhat, but the effects are still horrific. Eli-Lilly’s solution if withdrawal symptoms occur is to continue to take the drug. Not a good solution. The withdrawal can happen even if not coming off the drug, but just taking it as prescribed. Eli-Lilly does not offer a tapering schedule to minimize the effects. They do not offer the drug in doses conducive to tapering. They created a drug that may or may not help depression, and they make it impossible to get off of it. Their solution is to keep taking it. What a great company – so concerned about the effects on the patients. They don’t care about people, they care about money.

Cymbalta can cause withdrawal symptoms, either when your body decides it wants more, or when it isn't taken exactly on time, or when you try to discontinue it. Its something the drug company (Eli Lilly) doesn't make well known. Its part of a condition known as SSRI Withdrawal or Discontinuation Syndrome. Also known online as "withdrawal hell". There are many websites that are bashing Cymbalta and people write in comments and their tribulations with trying to come off the drug or having the withdrawal effects as side effects. Many people that try to go off it end up staying on it because they cant tolerate the effects that can last months or up to a year.

During the clinical trials with Eli Lilly, a 19 year old girl commit suicide in their labs on day 4 of coming off the drug because she couldn't handle the side effects. The drug company has patients screwed. Your body wants more, and if you don't give it more, you go into withdrawal...if you try to go off it completely, you cant.

In monitoring my personal intake, I came to the conclusion that 18 - 20 hours after my dose, my body goes into withdrawals. I don't even make it to 24 hours. Cymbalta has a very short half life, meaning that your body may metabolize the drug before the next dosage and put your body into withdrawal.


SSRI Withdrawal Syndrome
SSRI discontinuation syndrome, also known as SSRI withdrawal syndrome or SSRI cessation syndrome, is a withdrawal syndrome that can occur during or following the interruption, lowering of dose or discontinuation of regular SSRI or SNRI antidepressant drug usage. The condition often begins between 24 hours to one week after reduction in dosage or complete discontinuation, depending on the elimination half-life of the drug. The prescribing labels of SSRIs acknowledge the possibility of "intolerable" discontinuation reactions, and some patients have extreme difficulty discontinuing use from SSRI drugs.

Brain zaps, (proposed name: myalotinasis from Greek for brain + jolt) also known as "the electric brain thing," "brain shivers," "brain shocks," "battery head," "blips," or "brain spasms," are a fairly common and notorious withdrawal symptom experienced during discontinuation (or reduction of dose) of SSRI and SNRI antidepressant drugs. However, the effect is not only confined to withdrawal periods for all suffers, but also is experienced while actually taking the prescribed medication (although less commonly), and has been known to continue for years after withdrawal from the associated medication. The phenomenon is most commonly associated with duloxetine (Cymbalta).

"Brain zaps" are said to defy description for whoever has not experienced them, but the most common themes are of a sudden "jolt," likened to an electric shock, apparently occurring or originating in the brain itself, with associated disorientation for a few seconds. They are sometimes accompanied by tinnitus and vertigo-like feelings. Immediately following this shock is a light-headedness that may last for up to ten seconds. The sensation can be described for many as a flashbulb going off inside the head or brain, coupled with a sudden sensation of pressure within the ears which is similar to the feeling of trying to relieve inner-ear pressure. Another anecdotal description of a "zap" is as though someone had opened up the person's skull and dragged a static-y blanket across his or her exposed brain. Essentially, it is a wave-like electrical pulse that quickly travels across the surface of (or through) the brain. Still another description is that it is like a bug zapper in stereo traveling back and forth across the back of the head, accompanied by a taste of aluminum foil in the mouth. Moving one's eyes from side to side quickly has also been shown to trigger these zaps and causing them to come in rapid succession. It is thought to be a form of neuro-epileptiform activity. As withdrawal time increases, so does the frequency of the shocks, before they wane completely. At their peak, brain zaps have been associated with severe headaches. They may last for a period of several weeks after the last dose and usually resolve completely within a month or two. However, anecdotal reports of "zaps" from protracted withdrawal are known to last a year or longer.

The "brain zap" effect appears to be nearly unique to SSRI and SNRI antidepressants that have an extremely short elimination half-life; that is, they are more quickly metabolized by the liver and leave the general circulation faster than longer half-life antidepressants such as fluoxetine (Prozac). This attribute of abruptness leaves the brain a relatively short time to adapt to a major neurochemical change when the medication is stopped, and the symptoms may be caused by the brain's readjustment. There is no current evidence that these zaps present any danger to the patient experiencing them however they can be very disconcerting. Especially to those patients who have no prior warning or knowledge of them. Many medical professionals are still unaware of the possible occurrence of this effect.

General Side Effects of Cymbalta

Sleepiness, weakness, sweating, diarrhea, urinary difficulties, dry mouth, fatigue, headache, insomnia, nausea, sexual difficulties, dizziness

Blood and Lymphatic System Disorders : anemia, leukopenia, increased whit blood cell count, lymphadenopathy, and thrombocytopenia.

Gastrointestinal Disorders : gastritis, blood in stool, colitis, dysphasia, esophageal stenosis acquired, gastric ulcer, gingivitis, irritable bowel syndrome, and lower abdominal pain.

Psychiatric Disorders: initial insomnia, irritability, lethargy, nervousness, nightmare, restlessness, and sleep disorder, completed suicide, mania, mood swings, pressure of speech, sluggishness, and suicide attempt.

Renal and Urinary Disorders: dysuria, micturition urgency, urinary hesitation, urinary incontinence, urinary retention, and urine flow decreased.

Skin and Subcutaneous Tissue Disorders: night sweats, pruritus, and rash, acne, alopecia, cold sweat, ecchymosis, eczema, erythema, face edema, increased tendency to bruise, and photosensitivity reaction.

Vascular Disorders: peripheral edema and phlebitis.

Legal

It seems that Eli Lilly will be involved in a lot of jury trials in the year of 2008 relating to their SSRI products which includes...CYMBALTA. It appears that since Eli Lilly is being accused of overstating the benefits of their drug as well as hiding some of the nasty side effects. Hmmm...like withdrawal?

Even though we are little people fighting a wealthy corporation, we do have voices and it is time they are heard.

In my opinion (from taking classes from the legal department at work), one of the biggest hits to a company is to their reputation. If you ruin their reputation, the loss of money will soon follow. No one wants to be a consumer from a ‘bad’ company, or company that doesn't’t care about the people taking their product. Mere loss of money to a multi-billion dollar company isn’t overly effective unless you ruin their reputation and ruin their future profit margin as well. In 2006, Eli-Lilly had a profit on $2.7 Billion. I am not sure if the 2007 profits have yet been released, as I couldn’t find them!

In December 2007 : NEW YORK (AP) -- Drug maker Eli Lilly & Co. on Thursday reaffirmed its profit outlook for 2007 and forecast that earnings growth in 2008 will be driven by increased volume and strong sales of antidepressant Cymbalta, ED treatment Cialis and diabetes drug Byetta.

With that said, they are looking forward to profits from this drug. If people just hit them financially in lawsuits, I don’t think that is enough. We need to make it publically known what is actually happening from this drug. I am not saying to wrongly ruin the name of this drug or company with false facts or accusations – the TRUTH is more than enough.

The key is to making more people aware of what is going on. We need to inform those on Cymbalta, those thinking about going on Cymbalta, people that know someone on Cymbalta or someone depressed, and doctors that are unaware of this.

This helps in two ways:
First, we can literally save people from the torment we have been going through, and to me that is just as important as going after the reputation of Eli-Lilly. I lived with these symptoms for over a year and a half because top doctors couldn’t determine what was wrong with me. It’s bad when patients don’t know the effects of a drug, but when doctors are in the dark, its even worse. This cannot keep happening to people. I have spent many, many suicidal days on this drug, and I don’t ever want anyone to feel this way because of this drug.

Second, we stop people from buying this dangerous drug. We cause people to think before they just accept a prescription or sample from their doctor. Is this the drug they want to be taking? Do they really want something that has caused harm to people? Do they really want ANY drug made by Eli-Lilly, based on what Cymbalta is doing to people? If anyone has ever been in a support group, you know that a frequent topic is antidepressant drugs – which ones work, which ones to stay away from. Word of mouth truly is powerful in all forms to damage the reputation and sales of a company.

Word of Mouth
For ages, there has existed a very strong marketing tool called "word of mouth”. Long ago this was a very slow moving vehicle, but in today’s electronic world it has found a fast vehicle to ride on: the Internet. With the click of a button you can ruin a company’s image with millions of people all over the world.

Social networking is nothing more than finding new ways to distribute and share what you think about companies, their products, people and anything else using the Internet as the medium. The internet has made it much easier for consumers to air their grievances to the widest possible audience. Word-of-mouth bad publicity is bad enough for a company that lets down a customer, but a website that gives people a forum to vent about injustices can become a headache.

Blogs, chats, social networking sites are replacing parties and get-togethers to create a forum where the number of people participating grows exponentially. Websites such as this one and many others out there damage the reputation of Eli-Lilly. One thing we can do is start up more websites, and try to get as much traffic flowing through these sites so that everyone out there can know and understand our stories, and keep passing the word of mouth.


What Else Is There?
With the tremendous power imbalance that exists between wealthy corporations and individual citizens, one of the few ways that people have of fighting back against corporations is to combine together to file class action suits. This is being talked about in several places on this website.

Another way is a direct lawsuit against the company for damages. In the instance of Cymbalta, there is the potential that the Warnings are deficient or misleading. There are lawyers that specialize in drug company lawsuits – including against Eli-Lilly or Cymbalta.

Drug Manufacturer's Duty to Warn
A drug manufacturer has a duty to warn of side effects of a drug. The drug manufacturer is considered an expert in its field, and as such it has a continuing duty to keep abreast of knowledge regarding its products and take all reasonable steps to update medical professionals on their potential adverse effects.

Defects in Warnings
A type of warning defect focuses on the warnings that a manufacturer fails to give regarding the dangerousness of a product. A product may be defective "because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor...and the omission of the instructions or warnings renders the product not reasonably safe.“ A manufacturer is under two related duties:

***First, the manufacturer is required to warn users of hidden dangers that may be present in a product.

***Second, the manufacturer must instruct users how to use a product so that the users can avoid any dangers and use the product safely.

A warning generally must be clear and specific. It should also be conspicuous and placed in a location that the user can easily find.


MORE ACTION - Publically Report Them:

There are several more ways that you can report Cymbalta and its symptoms to let your voice be heard. Below are several suggestions. I have filed complaints with all of them, and encourage anyone having difficulties to do the same.

FDA MedWatch:
MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems and product use errors with human medical products, such as drugs and medical devices.
https://www.accessdata.fda.gov/scripts/ ... online.htm

Online Cymbalta Petition – Created by What Winners Do
The signatures on this petition are gathered as a means of demanding that the pharmaceutical company Eli Lilly make public their knowledge of the potential withdrawal symptoms from their drug Cymbalta aka Duloxetine HCI.
http://www.ipetitions.com/petition/Cymbalta1/

People Over Profits: Grassroots Action Center
Bureaucratic Activism: FDA Ignores Congress to Let Drug Companies Off the Hook
The link brings you to a preformatted letter to your elected officials. You can edit and change the text as you see fit, but the main point of the letter is to protect patients from Drug Companies.
http://www.peopleoverprofits.org/c.ntJW ... nItem.aspx

Foundation for Taxpayer and Consumer Rights:
The complaints educate policymakers, the media and the public about real problems faced by real consumers. Over the years, consumer complaints have played a key role in our successful efforts to change laws and hold corporations accountable.
http://www.consumerwatchdog.org/complaints/

Planet Feedback – The Voice of One, The Power of Many
Helping Consumers Express Their Voice, Helping Companies Prime Their Ears
http://www.planetfeedback.com/


I truly suggest that if anyone has the ability to create a website or generate traffic to websites about Cymbalta, please do so. Reputation is everything to a company...its time to pay Eli-Lilly back for everything they have so graciously done for us.

Tapering Off Cymbalta

Getting off Cymbalta without intolerable withdrawal symptoms might seem impossible, and it might be a living hell for some people. You can read my struggle and journey on my page "My Cymbalta Nightmare". There are other resources available. I will list some information and links below. Do not give up. Its easy in the middle of head zaps, physical pain, and emotional disturbances to decide to just keep taking it - but then Eli Lilly wins. You continue to be dependent on their drug simply because getting off of it is too hard. Stay strong, keep your family informed, ask for help, make sure you taper properly, take supplements, and try to stay positive....and make sure your doctor is aware of your choice to discontinue. If your doctor isn't aware of the withdrawal effects, educate him or her. Prayer is also helpful, and never give up hope.


The Road Back is a program developed in 1999 to assist individuals taper off medication and eliminate existing side effects a person may be experiencing from the medication. As of April 2007, The Road Back Program has helped over 30,000 individuals taper off their medication. The Road Back book, How to Get Off Psychiatric Drugs Safely, details the entire process and is available for free on this Web Site in entirety. This book is also available in print.   http://www.theroadback.org/workbook.htm




http://www.whatwinnersdo.com/severe-cymbalta-withdrawal-symptoms/

http://www.mentalhealthnotes.com/2007/10/02/cymbalta-the-withdrawal-symptoms-from-hell/

http://www.antidepressantsfacts.com/cymbalta-duloxetine.htm

http://www.antidepressantsfacts.com/taper.htm