Cymbalta (Duloxetine)

Cymbalta (Duloxetine) was created by Lilly researchers. David Robertson, David Wong, a co-discoverer of fluoxetine, and Joseph Krushinski are listed as inventors on the patent application filed in 1986 and granted on September 11th 1990.
- USPTO Patent Full-Text and Image Database, retrieved March 30, 2011.

"Cymbalta (duloxetine) is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). Cymbalta affects chemicals in the brain that may become unbalanced and cause depression.

Cymbalta is used to treat major depressive disorder and general anxiety disorder.

Cymbalta is also used to treat a chronic pain disorder called fibromyalgia, treat pain caused by nerve damage in people with diabetes (diabetic neuropathy) and to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain..."
- How does Cymbalta work? on Body & Health Canada - Factsheets

"The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • changes in sexual desire or ability
  • decreased appetite
  • diarrhea or constipation
  • difficulty sleeping
  • dizziness
  • dry mouth
  • fatigue
  • heartburn
  • hot flushes
  • increased sweating
  • nausea
  • runny nose
  • sleepiness
  • vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • agitation
  • anxiety
  • eye pain or blurred vision
  • hallucinations
  • inability to pass urine
  • new or worsening emotional or behavioural problems
  • overactive thoughts or behaviour
  • skin bruising (severe) or unusual bleeding
  • symptoms of liver damage (e.g., nausea, vomiting, or loss of appetite,
  • combined with yellow skin or eyes, dark urine, or itching)
  • symptoms of low sodium levels in the blood (e.g., tiredness,
  • weakness, and confusion combined with achy, stiff, or uncoordinated muscles)
  • symptoms of serotonin syndrome (e.g., experiencing most or all of the following: confusion, restlessness, sweating, shivering, shaking, hallucinations, fast heartbeat, and sudden muscle jerking)
  • uncontrollable face or body movements

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures
  • severe skin rash
  • signs of an allergic reaction (e.g., shortness of breath or difficulty breathing; hives; swelling of the eyes, mouth, lips, or throat)

...The safety and effectiveness of this medication have not been established for children. Children under 18 years are at an increased risk of suicidal thoughts or behaviour if they take duloxetine."

-What side effects are possible with Cymbalta? on Body and Health Canada- Factsheet

"Our 24-year-old daughter was experiencing anxiety. Her doctor prescribed clonazepam (also known as Klonopin). Along with that, he gave her free samples of an antidepressant called Cymbalta.

Our daughter took these medicines beginning on Thursday, but they made her feel bad. By Sunday evening, she began talking about losing a desire to live. On Monday morning, she drove her beautiful 4-year-old daughter to school and then drove to her fiance's home. When she got there, she took a gun and killed herself.

We are at a loss as to what happened. Our daughter might still be here if not for Cymbalta."
- Cymbalta & Suicide

"No one could say that about Eli Lilly's clinical trials for Cymbalta, or duloxetine, its successor to Prozac. For years, Lilly had been testing it in some of the most secure, well-funded research centers in the world. By 2003, Lilly was so assured of the drugs impending approval that it hired a powerful New York public relations firm just to walk the aisles of the annual convention of the American Psychiatric Association and hand out the results of the studies. Th e company employed a troop of PR specialists to work the financial and health press, confidently predicting that approval was (their words to me) "just around the corner". Lilly analysts pegged their sales forecasts for Cymbalta at $2 billion a year.
The hype notwithstanding, by late 2003 Lilly had run into a number of unanticipated setbacks. One was particularly onerous. The FDA requested that it conduct a new study of the drug in healthy volunteers- people without depression. Healthy-volunteer studies are used to determine how the human body metabolizes a drug and to flesh out proper dosages and side-effect profiles. The company promptly began aggressively advertising for volunteers, offering $150 a day for what would likely be a thirty-day study. The trials would be held at Lilly's own, hotel-like complex at the Indiana University Medical Center. It was state-of-the-art in every sense.
Tracy Johnson, a nineteen-year-old student at nearby Indiana Bible College was intrigued with Lilly's ads, and in December she decided to drop out of school in order to partake of the lucrative offer. She needed the money, and the study seemed to provde relative comfort: housing and meals as well as what would be, to any student, a tidy sum of cash.Lilly told her about the risks involved in taking Cymbalta. There had been four suicides over several years of testing, but those, the company stressed, had occured among patients who were depressed. Tracy was not. Lilly believed that there was no evidence that it might induce suicidal thoughts, a strange assumption given the problematic history of antidepressants, and the fact that, at the time, the FDA had ramped up its investigation of just that issue. Tracy Johnson signed up.
For the next month, she dutifully took her daily dose of Cymbalta. She was cheerful, as usual. She submitted to the blood tests and other monitoring provided by Lilly at its Indiana University research center, where she was free to come and go as she pleased. Over twenty days, her dosages were increased, eventually to five times the recommended dose, and then decreased. Her mood stayed the same. At the end of the month- by then she would have made roughly $4,50- she was placed on a placebo. Four days later, she spoke with one of her best friends and "sounded happy".
The next evening she was found dead. A nurse discovered her body in a bathroom of the Lilly complex. She had hung herself by tying a scarf to a shower rod. She did not leave a note.
Why? In the aftermath, a number of suggestions arose. A serious one concerned withdrawal syndrome. Perhaps Johnson, only nineteen, had been a particularly slow metabolizer of drugs in general. That might trigger reactions during the placebo period, later than expected. Cymbalta, after all, is similar to Effexor, which was known for causing severe withdrawal reaction upon discontinuance, and patients experiencing severe SSRI withdrawal had been known to commit suicide. On top of that, Cymbalta had been shown, a year before, to be a potent inhibitor of cytochrome P450, the liver enzyme responsible for processing drugs.
When the Indiana University review board looked into the case immediately after Johnson died, it did not rule on causality, but, rather, ordered Lilly to discontinue the recruiting operation and bring in an "independent psychiatrist" to evaluate the remaining participants (nineteen who dropped out right after the suicide). The company was also ordered to have patients sign a new consent form. (No one knows what was in it.) Lilly responded with its own investigation, which concluded that the drug was not implicated in the suicide. The Indianapolis coroner ruled the drug out as a suspect, but then later admitted that it had not tested Johnson's blood for traces of Cymbalta. In August 2004, the FDA agreed with Lilly. It approved Cymbalta for treatment of depression, inaugurating one of the biggest new drug launches in history.
I asked Steve Paul, Lilly's chief research and development officer , if the aggressive way in which drugs are marketed now might make patients in trials like Cymbalta's think that the risks were not as high as they truly were. This suggestion Paul brushed aside, but then added, without any prompting: "I think you are saying, 'Should we be careful not to over-incent people?' And you are right. We should not. And we are careful not to.' "

-pp. 210 -212, The Full Price in Generation RX: How Prescription Drugs are Altering American Lives, Minds, and Bodies by Greg Critser (2005)

"On Oct. 1, Crerar, who was taking Cymbalta and other drugs for severe depression, told his wife of 30 years that he planned to kill himself. Dolores Crerar, 73, told her husband that she "couldn't go on without you; kill me first," according to court records.

Crerar choked her, stabbed her 47 times and slit her throat before calling 911 to confess. He meant to kill himself after killing his wife but was too tired to do so, he told police.

Crerar was at a loss to explain his actions.

"I feel it's out of character for me to do something like that," he wrote in his confession. "I ask myself over and over again why did I do something like that and I can't answer that question."

But his lawyers say a doctor's decision to increase Crerar's dosage of Cymbalta four days before the murder pushed him to try to kill himself ."
- Cymbalta & Murder Acquittal

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