Psych Drug Truth

Common Cymbalta Side Effects

Cymbalta should not be reduced quickly.

Cymbalta

Anxiety - Insomnia - Agitation - Weight Gain

Cymbalta Withdrawal

 
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 Cymbalta withdrawal. Cymbalta withdrawal side effects, withdrawal warnings, withdrawal precautions, withdrawal adverse effects, overdose, withdrawal symptoms and natural alternatives. Before you begin the spiral down with Cymbalta, try giving your body what it really wants.

CYMBALTA

Cymbalta Withdrawal

Are you experiencing Cymbalta withdrawal?

The Road Back Program has been assisting people with Cymbalta withdrawal since 1999, and have helped over 50,000 people become drug free.

If you are suffering from Cymbalta withdrawal or Cymbalta side effects, The Road Back Program will likely be of help.

Head symptoms, anxiety, insomnia and other Cymbalta side effects can be a thing of the past. Click here and you will be directed to The Road Back Program web site. Their assistance is free.

If you have a detached retina and you were taking Cymbalta, there may be a connection. A detached retina is a Cymbalta side effect.

Cymbalta and Birth Defects

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. However, Cymbalta as well as other antidepressants are not proven to be much more effective than placebo.

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.

In July of 2006, the FDA issued a Health Advisory advising people of serious side effects if taking Cymbalta  while pregnant. The New England Journal of Medicine published a study that showed mothers who took Cymbalta during the second half of their pregnancy were six times more likely to have a baby with PPHN or heart defects.

Eli Lilly, makers of Cymbalta, have allegedly failed to adequately warn users that birth defects are a possible side effect of taking Cymbalta during pregnancy.

Eli Lilly announced today, February 26, 2007, that the U.S. Food and Drug Administration (FDA) has approved the antidepressant Cymbalta (R) (duloxetine HCl) for the treatment of generalized anxiety disorder (GAD). However, Cymbalta is known to cause anxiety once side effects begin in roughly 50% of the population.

Cymbalta tends to cause intestinal problems as well as joint pain more often than other Cymbalta side effects while a person is still taking the medication. Much like other antidepressants, Cymbalta causes side effects in the very symptom they are promoted to solve. Hence, Cymbalta joint pain.

To read more about Cymbalta from the FDA, click here and type Cymbalta in search box.

  1. Cymbalta withdrawal - Anorexia – No longer having a desire to eat.
     
  1. Cymbalta withdrawal - Apothous Stomatitis – Painful red and swollen open sores on a mucus membrane of the mouth commonly called a canker sore.
     
  1. Cymbalta withdrawal - Ataxia – Loss of the ability to move the body with coordination.
     
  1. Cymbalta withdrawal - Arterial Fibrillation – A condition of abnormal twitching of the muscles in the blood vessels that moves the oxygenated blood from the heart to the rest of the body.  The unusual twitching is rapid and irregular and replaces the normal rhythm of contraction of the muscle, which sometimes causes a lack of circulation and pulse.
     
  1. Cymbalta withdrawal - Blood Cholesterol Increased – An abnormal condition where there is a greater amount in the blood of the oily/fatty substances known as cholesterol.   Cholesterol is a necessary part of living cells (along with proteins and carbohydrates).  Because cholesterol only slightly dissolves in water, it can build up on the walls of the blood vessels, therefore blocking/decreasing the amount of blood flow, which causes blood pressure to go up.  If not corrected, this condition is associated with coronary artery disease.
     
  1. Cymbalta withdrawal - Blood Creatinine Increased – A greater than normal number of creatinine or muscular chemical waste molecules in the blood.  Creatinine plays a major role in energy production in muscles.  Since creatinine levels are normally maintained by the kidneys, Blood Creatinine Increased is an indicator of kidney malfunction or failure.
     
  1. Cymbalta withdrawal - Blood in Stool – The blood that is in your bowel movement usually comes from any place along your digestive tract (from your mouth to your anus).  The stool can appear black and foul-smelling (usually from the upper part of your digestive tract) or red or maroon-colored (usually from the large intestine area).  Hemorrhoids are the usual cause for blood in the bowels.

8.    Cymbalta withdrawal - Bundle Branch Block Right – These are specialized cells in the upper right heart chamber and are the heart’s pacemaker.  They send electrical signals to the heart that keeps it beating or contracting regularly.  Normally the signal goes to the lower heart chambers at the same time through the bundle of His (hiss) on both the left and right sides of the heart, so the lower chambers contract at the same time.  When the bundle is damaged on the right side, the signal does not fire at the same time as the left, which changes the pace of blood flow.  This can lead to a person fainting.

  1. Cymbalta withdrawal - Cardiac Failure – A heart disorder where the heart does not function as usual and may completely stop working.
     
  1. Cymbalta withdrawal - Cardiac Failure Congestive – The body is asking for the heart to supply more blood than it is capable of producing and maintaining.  Normally, a body can tolerate an increased amount of work for quite some time.  The condition is characterized by weakness, shortness of breath, and a fluid build-up in the body tissues causing swelling.
     
  1. Cymbalta withdrawal - Cold Sweat – The skin is clammy and moist and you feel chilled.  This is a reaction to a shock or pain as well as to fear and nervousness.
     
  1. Cymbalta withdrawal - Colitis – A condition where the large intestine becomes irritated from the use of the drug.
     
  1. Cymbalta withdrawal - Coronary Artery Disease – A condition where the blood vessels that mainly carry the blood away from the heart become clogged up or narrowed usually by fatty deposits.  The first symptom is pain spreading from the upper left body caused by not enough oxygen reaching the heart.
     
  1. Cymbalta withdrawal - Dehydration – An extreme loss of water from the body or the organs of the body as in sickness or not drinking enough fluids.
     
  1. Cymbalta withdrawal - Diplopia – The condition where a person is looking a one object and instead of normally seeing just the one object he sees two.  This is also call double vision.
     
  1. Cymbalta withdrawal - Diverticulitis – There are pouches or sacs on the inside of the intestines that look like fingers.  This increases the area for the body to absorb nutrients as they pass through the intestines.  These sacs become irritated and swollen and end up trapping waste that would normally be eliminated, causing pain and constipation.
     
  1. Cymbalta withdrawal - Dysarthria – The inability to control the mouth muscles when forming words so the words are not clearly spoken and heard.
     
  1. Cymbalta withdrawal - Dyslipidemia – The normal fat metabolism in the blood is interfered with.
     
  1. Cymbalta withdrawal - Dysphagia – Trouble swallowing or the inability to swallow.
     
  1. Cymbalta withdrawal - Ecchymosis – When a blood vessel breaks and creates a purple discoloration of the skin.
     
  1. Cymbalta withdrawal - Edema – An abnormal build up of excess fluids in the cells, tissues, and the spaces between the tissues creating swelling.
     
  1. Cymbalta withdrawal - Edema Peripheral – The abnormal build up of fluids in the tissues of the ankles and legs causing painless swelling in the legs, ankles, and feet.  If you squeeze the swollen area it leaves an indentation on the skin for a few minutes.
     
  1. Cymbalta withdrawal - Ejaculation Delayed – The man is not able to release sperm either during sexual intercourse or with manual stimulation in the presence of his sexual partner in spite of his wish to do so.
     
  1. Cymbalta withdrawal - Ejaculation Dysfunction – A condition where the man has one or more of the following symptoms:  He is not able to have an erection, not able to have an orgasm, has a decreased interest in sex, is sexually inhibited, or it is painful to ejaculate sperm.
     
  1. Cymbalta withdrawal - Erectile Dysfunction – Incapable of having sexual intercourse.  Even though a man desires sex he is inhibited in his sexual activity and is unable to have or maintain an erection of the penis.
     
  1. Cymbalta withdrawal - Erythema – a skin redness caused by the swelling with blood of the tiny blood vessels of the skin as in burns.
     
  1. Cymbalta withdrawal - Erythematous Rash – Redness of the skin from the swelling of the tiny blood vessels with skin irritation (itching, burning, tingling, pain) and breakouts (eruptions).

 

  1. Cymbalta withdrawal - Esophageal Stenosis Acquired – The tube that moves food from the mouth to the stomach narrows.
     
  1. Cymbalta withdrawal - Exfoliative Dermatitis – The unusual and not normal condition of scaling and shedding of the skin cells.  The skin is usually red colored.
     
  1. Cymbalta withdrawal - Face Edema – The tissues of the face become swollen.
     
  1. Cymbalta withdrawal - Feeling Jittery – A physical sensation of nervous unease.
     
  1. Cymbalta withdrawal - Gastric Irritation – An inflamed and sore stomach.
     
  1. Cymbalta withdrawal - Gastric Ulcer – An open, irritated, and infected sore in the wall of the stomach.
     
  1. Cymbalta withdrawal - Gingivitis – Sore, swollen and red gums in the mouth that bleed easily.
     
  1. Cymbalta withdrawal - Glaucoma – The delicate nerve to the eye, the optic nerve, becomes easily damaged with the build-up of excess fluid pressure within the eyeball.  The first sign of glaucoma is loss of peripheral (side) vision.  It can progress to total blindness.
     
  1. Cymbalta withdrawal - Hepatic Steatosis – Excessive amounts of fat in the liver.
     
  1. Cymbalta withdrawal - Hyperhidrosis – The triggering of an excess of sweat being produced on the soles of the feet, the palms, or the underarms which can cause embarrassment or losing grip on a pen or other items.
     
  1. Cymbalta withdrawal - Hyperkeratosis – An abnormal enlargement of the skin tissues causing the skin cells to increase in size.
     
  1. Cymbalta withdrawal - Hyperlipidemia – An abnormally high number of fat cells in the blood.
     
  1. Cymbalta withdrawal - Hypertriglyceridemia – Too many triglycerides in the blood. 

Triglycerides are three fatty acids bound together in one molecule stored by the body and available to create high levels of energy when used. 

  1. Cymbalta withdrawal - Hypoesthesia – A partial loss of sensation or general loss of awareness.
     
  1. Cymbalta withdrawal - Impaired Gastric Emptying – The contents of the stomach are not passed into the intestines as normal due to the stomach losing the muscular strength to do so.
     
  1. Cymbalta withdrawal - Increased White Blood cell Count – This is an increase in the number of cells in the blood that are responsible for the removal of bacteria and other unwanted particles.  They fight disease and infection by enclosing foreign particles and removing them.  An example of a disease that would increase white blood cell count would be Leukemia.
     
  1. Cymbalta withdrawal - Insomnia – Not able to fall asleep or sleeping for a shorter time than desired, thus not being able to properly rest and feeling un-refreshed.  As a result, a person can become irritable, have difficulty concentrating and feel a lack of energy.  This can be caused by stimulants such as by caffeine or drugs or by mental anxiety and stress.  Mental stress can be communicated and relieved.
     
  1. Cymbalta withdrawal - Irritable Bowel Syndrome – A painful condition where the either the muscles or the nerves of the lower intestines, are not responding normally.  This results in an alternating condition of diarrhea followed by constipation, back and forth.
     
  1. Cymbalta withdrawal - Keratoconjunctivitis Sicca – A condition where the outer coating of the eyeball is dry because of a decrease in the normal amount of tears in the eye.  As a result, the eyeball and inside of the eyelid thickens and hardens sometimes causing the vision to be less sharp.
     
  1. Cymbalta withdrawal - Leukopenia – An unnaturally low number of white blood cells circulating in the blood.
     
  1. Cymbalta withdrawal - Loose Stools – The bowel movement is runny instead of formed.
     
  1. Cymbalta withdrawal - Lower Abdominal Pain – A hurtful irritation of the nerve endings in the area of the hipbones housing the lower digestive tract.  Pain usually means tissue damage.
     
  1. Cymbalta withdrawal - Lymphadenopathy – The lymph nodes, where the immune cells are located, become larger than is normal because of a high concentration of white blood cells.
     
  1. Cymbalta withdrawal - Macular Degeneration – The gradual loss of central vision, which is the sharpest vision while peripheral eyesight, is unaffected.
     
  1. Cymbalta withdrawal - Maculopathy – An abnormal condition of the yellow spot of the eye, which is located in the center of the inner lining of the eyeball and connected to the main nerve to the eye and is responsible for sharp vision.
     
  1. Cymbalta withdrawal - Mania – Unusually irrational, excessive and/or exaggerated behavior or moods ranging from enthusiasm, sexuality, gaiety, impulsiveness and irritability to violence.
     
  1. Cymbalta withdrawal - Melena – Abnormally darkly colored stools as a result of hemorrhaging in the digestive tract where the blood has interacted with the digestive juices creating the dark color in the bowel movement.
     
  1. Cymbalta withdrawal - Micturition Urgency – A sudden desire to urinate usually followed by leakage.
     
  1. Cymbalta withdrawal - Mood Swings – An emotional shifting as from a state of happiness to a state of depression for a period of time.
     
  1. Cymbalta withdrawal - Myocardial Infarction – The blood going to the heart is delayed or stopped causing middle muscle tissue in the heart wall to die.
     
  1. Cymbalta withdrawal - Nasopharyngitis – Irritation, redness and swelling tissues in the nose and the tube leading from the mouth to the voice box as well as the tubes leading to the ears.
     
  1. Cymbalta withdrawal - Nephropathy – An abnormally functioning or diseased kidney.
     
  1. Cymbalta withdrawal - Nervousness – Jumpy, jittery, anxious, and troubled with an irritable temperament.
     
  1. Cymbalta withdrawal - Night Sweats – The water-salt, waste product the skin releases is called sweat or perspiration.   With night sweats you become wide awake in the middle of the night shivering and cold and wet with your sheets/pajamas soaked in perspiration making it difficult to go back to sleep.
     
  1. Cymbalta withdrawal - Nightmare – Dreams that make you afraid or leave feelings of fear, terror, and upset long after waking up.
     
  1. Cymbalta withdrawal - Orgasm Abnormal – Unable to have an orgasm with normal sexual stimulation.
     
  1. Cymbalta withdrawal - Oropharyngeal Swelling – A swelling in the area from the soft part of the roof of the mouth to the back of the mouth.
     
  1. Cymbalta withdrawal - Pain in Extremity – A painful feeling in the legs, arms, hands, and feet.
     
  1. Cymbalta withdrawal - Pharyngolaryngeal Pain – Pain in the area of the respiratory tract (organs of breathing) from the throat to the voice box and above the windpipe.
     
  1. Cymbalta withdrawal - Photopsia – A condition where a person see lights, sparks or colors in front of your eyes.
     
  1. Cymbalta withdrawal - Photosensitivity Reaction – An exaggerated sunburn reaction that is not normal in proportion to the amount of exposure to the light.
     
  1. Cymbalta withdrawal - Pollakiuria – Urinating much more frequently than normal – as often as once every five to fifteen minutes.
     
  1. Cymbalta withdrawal - Pressure of Speech – A condition where the individual cannot voice his ideas fast enough with the pressure of there being not enough time to say it.
     
  1. Cymbalta withdrawal - Pruritic Rash – Extremely itchy, red, swollen bumps on the skin.
     
  1. Cymbalta withdrawal - Pyrexia – Fever or the increase in body temperature that is usually a sign of infection.
     
  1. Cymbalta withdrawal - Retinal Detachment – The thin layer lining the back of the eyeball (the retina) detaches from the back of the eyeball.  This thin layer is like the film of a camera because it sends the images a person views to the brain.  When it detaches it causes a reduced ability to see.
     
  1. Cymbalta withdrawal - Rigors – Shivering or shaking of the body as if chilled, preventing normal responses.
     
  1. Cymbalta withdrawal - Skin Ulcer – An open sore or infected skin eruption with swelling, redness, pus, and irritation.
     
  1. Cymbalta withdrawal - Sleep Disorder – These are a list of sleep disorders such as teeth grinding, insomnia, jet lag, sleep walking, abnormally falling asleep during the middle of a conversation after a full night’s rest, uncontrolled body motions keeping one awake, etc.
     
  2. Cymbalta withdrawal - Suicide, Completed – An attempted attack on oneself that is life threatening results in death.
     
  1. Cymbalta withdrawal - Upper Respiratory Tract Infection – Where the organs of breathing near the mouth such as the nose and sinuses, become infected and are usually treated by antibiotics.
     
  1. Cymbalta withdrawal - Urinary Hesitation – Hard to start or hard to continue emptying one’s bladder.
     
  1. Cymbalta withdrawal - Urinary Incontinence – Urinating without intending to do so because of a weakening of the muscles in the hip area from the drug affecting the nerves or the drug blocking a persons thinking process.
     
  1. Cymbalta withdrawal - Urinary Retention – The inability to completely empty the bladder despite having the urge to do so.  This can lead to infections or damage to the urinary organs.
     
  1. Cymbalta withdrawal - Urine Flow Decreased – Dehydration of the body causing a lesser flow of urine than normal with the body reabsorbing the waste.
     
  1. Cymbalta withdrawal - Urine Output Decreased – A condition where the output of urine produced in a 24-hour period is less than 500 ml.
     
  1. Cymbalta withdrawal - Weight Decreased – Unintentional weight loss.
     
  2. Cymbalta withdrawal – Weight Increased – An unusual, usually rapid weight increase.

Cymbalta Clinical Trials

High-dose duloxetine for treatment-resistant obsessive-compulsive disorder: a case report with sustained full remission.

Yeh YW, Chen CH, Kuo SC, Wang SC, Chen CK, Feng HM.

Clin Neuropharmacol. 2009 May-Jun;32(3):174-6. No abstract available.

PMID: 19483491 [Cymbalta - in process]

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Duloxetine: a review of its use in the treatment of generalized anxiety disorder.

Carter NJ, McCormack PL.

CNS Drugs. 2009;23(6):523-41. doi: 10.2165/00023210-200923060-00006.

PMID: 19480470 [Cymbalta - in process]

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Fibromyalgia: a complex syndrome requiring a multidisciplinary approach.

Spaeth M, Briley M.

Hum Psychopharmacol. 2009 May 28;24(S1):S3-S10. [Epub ahead of print]

PMID: 19479907 [Cymbalta - as supplied by publisher]

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The psychiatrist confronted with a fibromyalgia patient.

Kasper S.

Hum Psychopharmacol. 2009 May 28;24(S1):S25-S30. [Epub ahead of print]

PMID: 19479904 [Cymbalta - as supplied by publisher]

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Total residue analysis of swabs by ion mobility spectrometry.

Strege MA.

Anal Chem. 2009 Jun 1;81(11):4576-80.

PMID: 19476393 [Cymbalta - in process]

A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain.

Skljarevski V, Ossanna M, Liu-Seifert H, Zhang Q, Chappell A, Iyengar S, Detke M, Backonja M.

Eur J Neurol. 2009 May 12. [Epub ahead of print]

PMID: 19469829 [Cymbalta - as supplied by publisher]

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A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia.

Chappell AS, Littlejohn G, Kajdasz DK, Scheinberg M, D'Souza DN, Moldofsky H.

Clin J Pain. 2009 Jun;25(5):365-75.

PMID: 19454869 [Cymbalta - in process]

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Brain Functional Changes and Duloxetine Treatment Response in Fibromyalgia: A Pilot Study.

Hunter AM, Leuchter AF, Cook IA, Abrams M, Siegman BE, Furst DE, Chappell AS.

Pain Med. 2009 Apr 22. [Epub ahead of print]

PMID: 19453962 [Cymbalta - as supplied by publisher]

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Serotonin syndrome induced by duloxetine.

Hadikusumo B, Ng B.

Aust N Z J Psychiatry. 2009 Jun;43(6):581-2. No abstract available.

PMID: 19452666 [Cymbalta - in process]

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Chronic oral nicotine increases brain [(3)H]epibatidine binding and responsiveness to antidepressant drugs, but not nicotine, in the mouse forced swim test.

Andreasen JT, Nielsen EO, Redrobe JP.

Psychopharmacology (Berl). 2009 May 12. [Epub ahead of print]

PMID: 19452140 [Cymbalta - as supplied by publisher]

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Stress incontinence.

Onwude JL.

Clin Evid (Online). 2009 Apr 14;2009. pii: 0808.

PMID: 19445750 [Cymbalta - in process]

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Treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis.

Serretti A, Chiesa A.

J Clin Psychopharmacol. 2009 Jun;29(3):259-66.

PMID: 19440080 [Cymbalta - in process]

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Antidepressant-associated myoclonic status in a patient with symptomatic generalized epilepsy: does risk occur with therapeutic doses?

Melani F, Rosati E, Chiocchetti B, Muscas GC.

Epilepsy Behav. 2009 Apr;14(4):681-3. Epub 2009 Jan 31.

PMID: 19435583 [Cymbalta - in process]

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Advances in the management of diabetic peripheral neuropathy.

Tesfaye S.

Curr Opin Support Palliat Care. 2009 Jun;3(2):136-43.

PMID: 19421063 [Cymbalta - in process]

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Nontricyclic antidepressants for neuropathic pain #187.

Hawley P.

J Palliat Med. 2009 May;12(5):476-7.

PMID: 19416046 [Cymbalta - in process]

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Pharmacotherapy of chronic pain: a synthesis of recommendations from systematic reviews.

Kroenke K, Krebs EE, Bair MJ.

Gen Hosp Psychiatry. 2009 May-Jun;31(3):206-19. Epub 2009 Mar 4.

PMID: 19410099 [Cymbalta - in process]

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Clinical outcome and tolerability of duloxetine in the treatment of major depressive disorder: a 12-week study with plasma levels.

Volonteri L, Colasanti A, Cerveri G, Fiorentini A, De Gaspari I, Mauri M, Valli A, Papa P, Mencacci C.

J Psychopharmacol. 2009 Apr 30. [Epub ahead of print]

PMID: 19406851 [Cymbalta - as supplied by publisher]

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Anti-nociceptive effect of duloxetine in mouse model of diabetic neuropathic pain.

Kuhad A, Bishnoi M, Chopra K.

Indian J Exp Biol. 2009 Mar;47(3):193-7.

PMID: 19405385 [Cymbalta - indexed for MEDLINE]

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Quality of Life Measurement in Antidepressant Trials. Is There an Added Value?

De Fruyt J, Demyttenaere K.

Psychother Psychosom. 2009 Apr 28;78(4):212-219. [Epub ahead of print]

PMID: 19401621 [Cymbalta - as supplied by publisher]

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[Severe forms of depression: The efficacy of escitalopram.]

Spadone C.

Encephale. 2009 Apr;35(2):152-9. Epub 2009 Mar 31. French.

PMID: 19393384 [Cymbalta - in process]

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Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial.

Garcia-Campayo J, Serrano-Blanco A, Rodero B, Magallon R, Alda M, Andres E, Luciano JV, Lopez-Del Hoyo Y.

Trials. 2009 Apr 23;10(1):24. [Epub ahead of print]

PMID: 19389246 [Cymbalta - as supplied by publisher]

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Duloxetine in fibromyalgia: rejection. Marketing authorization rejected and rightly so.

[No authors listed]

Prescrire Int. 2009 Feb;18(99):14.

PMID: 19388210 [Cymbalta - indexed for MEDLINE]

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Population pharmacokinetics of orally administered duloxetine in patients: implications for dosing recommendation.

Lobo ED, Quinlan T, O'Brien L, Knadler MP, Heathman M.

Clin Pharmacokinet. 2009;48(3):189-97. doi: 10.2165/00003088-200948030-00005.

PMID: 19385712 [Cymbalta - in process]

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Pharmacological modulation of movement-evoked pain in a rat model of osteoarthritis.

Chandran P, Pai M, Blomme EA, Hsieh GC, Decker MW, Honore P.

Eur J Pharmacol. 2009 Jun 24;613(1-3):39-45. Epub 2009 Apr 16.

PMID: 19376109 [Cymbalta - as supplied by publisher]

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Insomnia in patients with depression: some pathophysiological and treatment considerations.

Jindal RD.

CNS Drugs. 2009;23(4):309-29. doi: 10.2165/00023210-200923040-00004.

PMID: 19374460 [Cymbalta - in process]

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Escitalopram versus other antidepressive agents for depression.

Cipriani A, Santilli C, Furukawa TA, Signoretti A, Nakagawa A, McGuire H, Churchill R, Barbui C.

Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006532.

PMID: 19370639 [Cymbalta - in process]

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[Cymbalta in the treatment of chronic pain syndromes]

[No authors listed]

Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(3):32-4. Russian.

PMID: 19365388 [Cymbalta - in process]

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[Cymbalta (duloxetine) in the treatment of anxiety-depressive disorders in patients with discirculatory encephalopathy]

Rzheusskaia GV, Listopadov IuI, Bobrova MV, Umrudina AG.

Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(2):26-30. Russian.

PMID: 19365368 [Cymbalta - indexed for MEDLINE]

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Improvement With Duloxetine in an Adult ADHD Patient.

Tourjman SV, Bilodeau M.

J Atten Disord. 2009 Apr 9. [Epub ahead of print]

PMID: 19359667 [Cymbalta - as supplied by publisher]

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Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine-controlled study.

Cutler AJ, Montgomery SA, Feifel D, Lazarus A, Aström M, Brecher M.

J Clin Psychiatry. 2009 Apr;70(4):526-39. Epub 2009 Apr 7.

PMID: 19358790 [Cymbalta - in process]

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Is the significant superiority of escitalopram compared with other antidepressants clinically relevant?

Montgomery SA, Möller HJ.

Int Clin Psychopharmacol. 2009 May;24(3):111-8.

PMID: 19357527 [Cymbalta - in process]

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Duloxetine in the management of elderly patients with major depressive disorder: an analysis of published data.

Mancini M, Gianni W, Rossi A, Amore M.

Expert Opin Pharmacother. 2009 Apr;10(5):847-60.

PMID: 19351233 [Cymbalta - in process]

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Cooperative opioid and serotonergic mechanisms generate superior antidepressant-like effects in a mice model of depression.

Berrocoso E, Mico JA.

Int J Neuropsychopharmacol. 2009 Apr 3:1-12. [Epub ahead of print]

PMID: 19341511 [Cymbalta - as supplied by publisher]

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Duloxetine in the treatment of generalized anxiety disorder.

Norman TR, Olver JS.

Neuropsychiatr Dis Treat. 2008 Dec;4(6):1169-80.

PMID: 19337457 [Cymbalta - in process]

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Treatment options and patient perspectives in the management of fibromyalgia: future trends.

Lawson K.

Neuropsychiatr Dis Treat. 2008 Dec;4(6):1059-71.

PMID: 19337451 [Cymbalta - in process]

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Newer treatments for fibromyalgia syndrome.

Harris RE, Clauw DJ.

Ther Clin Risk Manag. 2008 Dec;4(6):1331-42.

PMID: 19337439 [Cymbalta - in process]

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Patient-Assessed Versus Physician-Assessed Disease Severity and Outcome in Patients With Nonspecific Pain Associated With Major Depressive Disorder.

Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S.

Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15.

PMID: 19333404 [Cymbalta - as supplied by publisher]

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Baseline severity of depression predicts antidepressant drug response relative to escitalopram.

Kilts CD, Wade AG, Andersen HF, Schlaepfer TE.

Expert Opin Pharmacother. 2009 Apr;10(6):927-36.

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Determination of duloxetine in human plasma by capillary electrophoresis with laser-induced fluorescence detection.

Musenga A, Amore M, Mandrioli R, Kenndler E, de Martino L, Raggi MA.

J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Apr 15;877(11-12):1126-32. Epub 2009 Mar 3.

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van de Vaart H, Falconer C, Quail D, Timlin L, Manning M, Tincello D, Tunn R.

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J Psychopharmacol. 2009 Mar 12. [Epub ahead of print]

PMID: 19282423 [Cymbalta - as supplied by publisher]

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The facilitatory effect of duloxetine combined with pelvic floor muscle training on the excitability of urethral sphincter motor neurons.

Mehnert U, Boy S, Widmer-Simitovic S, Reitz A, Schurch B.

Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):659-66. Epub 2009 Mar 7.

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Tomillero A, Moral MA.

Methods Find Exp Clin Pharmacol. 2008 Dec;30(10):761-82.

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Duloxetine treatment for women with premenstrual dysphoric disorder: a single-blind trial.

Ramos MG, Hara C, Rocha FL.

Int J Neuropsychopharmacol. 2009 Feb 27:1-8. [Epub ahead of print]

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Katz A.

Am J Nurs. 2009 Mar;109(3):59-63. Review. No abstract available.

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Duloxetine in acute major depression: review of comparisons to placebo and standard antidepressants using dissimilar methods.

Girardi P, Pompili M, Innamorati M, Mancini M, Serafini G, Mazzarini L, Del Casale A, Tatarelli R, Baldessarini RJ.

Hum Psychopharmacol. 2009 Apr;24(3):177-90.

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Open-label support for duloxetine for the treatment of panic disorder.

Simon NM, Kaufman RE, Hoge EA, Worthington JJ, Herlands NN, Owens ME, Pollack MH.

CNS Neurosci Ther. 2009 Winter;15(1):19-23.

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Fibromyalgia: presentation and management with a focus on pharmacological treatment.

Sumpton JE, Moulin DE.

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Srinivasulu P, Srinivas KS, Reddy RS, Mukkanti K, Buchireddy R.

Pharmazie. 2009 Jan;64(1):10-3.

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Pilot study of augmentation with aripiprazole for incomplete response in late-life depression: getting to remission.

Sheffrin M, Driscoll HC, Lenze EJ, Mulsant BH, Pollock BG, Miller MD, Butters MA, Dew MA, Reynolds CF 3rd.

J Clin Psychiatry. 2009 Feb;70(2):208-13. Epub 2009 Feb 10.

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Duloxetine in the treatment of generalized anxiety disorder.

Kornstein SG, Russell JM, Spann ME, Crits-Christoph P, Ball SG.

Expert Rev Neurother. 2009 Feb;9(2):155-65. Review.

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Escitalopram in the treatment of major depressive disorder: a meta-analysis.

Kennedy SH, Andersen HF, Thase ME.

Curr Med Res Opin. 2009 Jan;25(1):161-75.

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Reeves RR, Brister JC.

South Med J. 2008 Jul;101(7):769. No abstract available.

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Quilici S, Chancellor J, Löthgren M, Simon D, Said G, Le TK, Garcia-Cebrian A, Monz B.

BMC Neurol. 2009 Feb 10;9:6.

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Early symptom change prediction of remission in depression treatment.

Katz MM, Meyers AL, Prakash A, Gaynor PJ, Houston JP.

Psychopharmacol Bull. 2009;42(1):94-107.

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An 8-week, open-label trial of duloxetine for comorbid major depressive disorder and chronic headache.

Volpe FM.

J Clin Psychiatry. 2008 Sep;69(9):1449-54.

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A randomized, double-blind study of increasing or maintaining duloxetine dose in patients without remission of major depressive disorder after initial duloxetine therapy.

Kornstein SG, Dunner DL, Meyers AL, Whitmyer VG, Mallinckrodt CH, Wohlreich MM, Detke MJ, Hollandbeck MS, Greist JH.

J Clin Psychiatry. 2008 Sep;69(9):1383-92.

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Solid-phase microextraction using poly(pyrrole) film and liquid chromatography with UV detection for analysis of antidepressants in plasma samples.

Chaves AR, Chiericato Júnior G, Queiroz ME.

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Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis.

Cipriani A, Furukawa TA, Salanti G, Geddes JR, Higgins JP, Churchill R, Watanabe N, Nakagawa A, Omori IM, McGuire H, Tansella M, Barbui C.

Lancet. 2009 Feb 28;373(9665):746-58. Review.

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[Is medical therapy useful in the management of stress urinary incontinence?]

Oelke M, Seidler M, Uckert S, Gabuev A.

Urologe A. 2009 Mar;48(3):228-32. German.

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The role of duloxetine in the treatment of anxiety disorders.

De Berardis D, Serroni N, Carano A, Scali M, Valchera A, Campanella D, D'Albenzio A, Di Giuseppe B, Moschetta FS, Salerno RM, Ferro FM.

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Current considerations in the treatment of generalized anxiety disorder.

Katzman MA.

CNS Drugs. 2009;23(2):103-20. doi: 10.2165/00023210-200923020-00002. Review.

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Pharmacological assessment of the rat formalin test utilizing the clinically used analgesic drugs gabapentin, lamotrigine, morphine, duloxetine, tramadol and ibuprofen: influence of low and high formalin concentrations.

Munro G.

Eur J Pharmacol. 2009 Mar 1;605(1-3):95-102. Epub 2009 Jan 11.

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Furuta A, Asano K, Egawa S, de Groat WC, Chancellor MB, Yoshimura N.

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Mease PJ, Russell IJ, Kajdasz DK, Wiltse CG, Detke MJ, Wohlreich MM, Walker DJ, Chappell AS.

Semin Arthritis Rheum. 2009 Jan 17. [Epub ahead of print]

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Wasan AD, Ossanna MJ, Raskin J, Wernicke JF, Robinson MJ, Hall JA, Edwards SE, Lipsius S, Meyers AL, McCarberg BH.

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A continuous responder analysis from a long-term trial of duloxetine treatment for generalized anxiety disorder: implications for the randomized withdrawal relapse prevention study design.

Llorca PM, Bodkin JA, Spann M, Ball SG, Russell JM, Ball SG.

J Clin Psychopharmacol. 2009 Feb;29(1):96-7. No abstract available.

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Voznesenskaia TG.

Zh Nevrol Psikhiatr Im S S Korsakova. 2008;108(11):98-101. Russian. No abstract available.

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Acuna C.

Drugs Today (Barc). 2008 Oct;44(10):725-34. Review.

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Herrera-Guzmán I, Gudayol-Ferré E, Herrera-Guzmán D, Guàrdia-Olmos J, Hinojosa-Calvo E, Herrera-Abarca JE.

J Psychiatr Res. 2009 Jun;43(9):855-63. Epub 2009 Jan 6.

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de Tommaso M, Sardaro M, Vecchio E, Serpino C, Stasi M, Ranieri M.

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Sipkoff M.

Manag Care. 2008 Dec;17(12):9-10. No abstract available.

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Melo LP, Nogueira AM, Lanças FM, Queiroz ME.

Anal Chim Acta. 2009 Feb 2;633(1):57-64. Epub 2008 Nov 25.

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Perlis RH, Fijal B, Adams DH, Sutton VK, Trivedi MH, Houston JP.

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Preskorn SH, Nichols AI, Paul J, Patroneva AL, Helzner EC, Guico-Pabia CJ.

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Gartlehner G, Gaynes BN, Hansen RA, Thieda P, DeVeaugh-Geiss A, Krebs EE, Moore CG, Morgan L, Lohr KN.

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Qaseem A, Snow V, Denberg TD, Forciea MA, Owens DK; Clinical Efficacy Assessment Subcommittee of American College of Physicians.

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Antidepressant-induced sweating alleviated by aripiprazole.

Lu BY, Cullen CE, Eide CE, Williams CC, Apfeldorf WJ.

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Bernardi S, Pallanti S.

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Rane VP, Shinde DB.

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Boomershine CS.

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Sullivan MD, Bentley S, Fan MY, Gardner G.

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Pereira P, Gianesini J, da Silva Barbosa C, Cassol GF, Von Borowski RG, Kahl VF, Cappelari SE, Picada JN.

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Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

Holman AJ.

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Soni P, Mariappan TT, Banerjee UC.

Talanta. 2005 Oct 31;67(5):975-8.

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Postprostatectomy Incontinence: All About Diagnosis and Management.

Bauer RM, Bastian PJ, Gozzi C, Stief CG.

Eur Urol. 2008 Oct 23. [Epub ahead of print]

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[Dermatological side effects during therapy with serotonin noradrenaline reuptake inhibitors]

Gross CM, Klöcker M, Jakob T, Klecha D.

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Wade AG, Schlaepfer TE, Andersen HF, Kilts CD.

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Rudel A, Hubert C, Juckel G, Edel MA.

Psychiatr Prax. 2008 Oct 15. [Epub ahead of print] German.

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Is duloxetine effective treatment for depression with atypical features?

Stewart JW, Deliyannides DA, McGrath PJ.

Int Clin Psychopharmacol. 2008 Nov;23(6):333-6.

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Brecht S, Kajdasz D, Ball S, Thase ME.

Int Clin Psychopharmacol. 2008 Nov;23(6):317-24.

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Serra E.

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Wade AG, Fernández JL, François C, Hansen K, Danchenko N, Despiegel N.

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Wise TN.

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Differences in medication adherence and healthcare resource utilization patterns: older versus newer antidepressant agents in patients with depression and/or anxiety disorders.

Sheehan DV, Keene MS, Eaddy M, Krulewicz S, Kraus JE, Carpenter DJ.

CNS Drugs. 2008;22(11):963-73.

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Englisch S, Fritzinger M, Zink M.

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Hansen R, Gaynes B, Thieda P, Gartlehner G, Deveaugh-Geiss A, Krebs E, Lohr K.

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Uçeyler N, Offenbächer M, Petzke F, Häuser W, Sommer C.

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Fishbain DA, Detke MJ, Wernicke J, Chappell AS, Kajdasz DK.

Curr Med Res Opin. 2008 Sep 30. [Epub ahead of print]

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Hayashida K, Eisenach JC.

Eur J Pharmacol. 2008 Nov 19;598(1-3):21-6. Epub 2008 Sep 17.

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Patroneva A, Connolly SM, Fatato P, Pedersen R, Jiang Q, Paul J, Guico-Pabia C, Isler JA, Burczynski ME, Nichols AI.

Drug Metab Dispos. 2008 Dec;36(12):2484-91. Epub 2008 Sep 22.

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Tomillero A, Moral MA.

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Antidepressants targeting the serotonin reuptake transporter act via a competitive mechanism.

Apparsundaram S, Stockdale DJ, Henningsen RA, Milla ME, Martin RS.

J Pharmacol Exp Ther. 2008 Dec;327(3):982-90. Epub 2008 Sep 18.

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Duloxetine in treatment of refractory chronic tennis elbow: Two case reports.

Wani ZA, Dhar SA, Butt MF, Rather YH, Sheikh S.

J Med Case Reports. 2008 Sep 17;2:305.

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Antidepressant behavioral effects of duloxetine and amitriptyline in the rat forced swimming test.

Menezes HS, Bueno BB, Ciulla L, Schuh A, Luz Fde F, Alves RJ, Abegg MP, Cirino SL.

Acta Cir Bras. 2008 Sep-Oct;23(5):447-50.

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Duloxetine treatment of social anxiety disorder with comorbid major depression.

Lin CC.

J Clin Psychopharmacol. 2008 Oct;28(5):591-2; author reply 592-3. No abstract available.

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Moore RA, Derry S, McQuay HJ.

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Wise TN, Meyers AL, Desaiah D, Mallinckrodt CH, Robinson MJ, Kajdasz DK.

Prim Care Companion J Clin Psychiatry. 2008;10(4):270-5.

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Antidepressant drugs and cardiovascular pathology: a clinical overview of effectiveness and safety.

Taylor D.

Acta Psychiatr Scand. 2008 Dec;118(6):434-42. Epub 2008 Sep 8. Review.

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Duloxetine for neuropathic pain based on recent clinical trials.

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Update on pharmacotherapy guidelines for the treatment of neuropathic pain.

Dobecki DA, Schocket SM, Wallace MS.

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[No authors listed]

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Wernicke JF, Prakash A, Kajdasz DK, Houston J.

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Uçeyler N, Häuser W, Sommer C.

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Muneoka K, Shirayama Y, Takigawa M, Shioda S.

Neurochem Res. 2009 Mar;34(3):542-55. Epub 2008 Aug 27.

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Stevens DL.

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Bellino S, Paradiso E, Bozzatello P, Bogetto F.

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Dekeyne A, Millan MJ.

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Perahia DG, Quail D, Desaiah D, Montejo AL, Schatzberg AF.

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Molteni R, Calabrese F, Mancini M, Racagni G, Riva MA.

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Wells KA, Losin WG.

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Spina E, Santoro V, D'Arrigo C.

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Strombom I, Wernicke JF, Seeger J, D'Souza DN, Acharya N.

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Wernicke J, Acharya N, Strombom I, Gahimer JL, D'Souza DN, Dipietro N, Uetrecht JP.

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Pharmacokinetics

  CYMBALTA has an elimination half-life of about 12 hours (range 8 to 17 hours) and its pharmacokinetics are dose proportional over the therapeutic range. Steady-state plasma concentrations are typically achieved after 3 days of dosing. Elimination of CYMBALTA is mainly through hepatic metabolism involving two P450 isozymes, CYP2D6 and CYP1A2.

  Absorption and Distribution – Orally administered CYMBALTA is well absorbed. There is a median 2-hour lag until absorption begins (T lag), with maximal plasma concentrations C max) of CYMBALTA occurring 6 hours post dose. Food does not affect the Cmax of CYMBALTA, but delays the time to reach peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (AUC) by about 10%. There is a 3-hour delay in absorption and a one-third increase in apparent clearance of CYMBALTA after an evening dose as compared to a morning dose.

  The apparent volume of distribution averages about 1640 L. CYMBALTA is highly bound (>90%) to proteins in human plasma, binding primarily to albumin and ą1-acid glycoptrotein. Plasma protein binding of CYMBALTA is not affected by renal or hepatic impairment.

  Metabolism and Elimination – Biotransformation and disposition of CYMBALTA in humans have been determined following oral administration of 14C-labeled CYMBALTA. CYMBALTA comprises about 3% of the total radiolabeled material in the plasma, indication that it undergoes extensive metabolism to numerous metabolites. The major biotransformation pathways for CYMBALTA involve oxidation of the naphthyl ring followed by conjugation and further oxidation. Both CYP2D6 and CYP1A2 catalyze the oxidation of the naphthyl ring in vitro.   Metabolites found in plasma include 4 –hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate. Many additional metabolites have been identified in urine, some representing only minor pathways of elimination. Only trace (1% of the dose) amounts of unchanged CYMBALTA are present in the urine. Most (about 70%) of the CYMBALTA dose appears I the urine as metabolites of CYMBALTA; about 20% is excreted in the feces.

  Smoking Status – CYMBALTA bioavailability (AUC) appears to be reduced by about one-third in smokers. Dosage modifications are not recommended for smokers. Back to top of page

  Race – No specific pharmacokinetic study was conducted to investigate the effects of race.

  Renal Insufficiency – Limited data are available on the effects of CYMBALTA in patients with end stage renal disease (ESRD). After a single 60-mg dose of CYMBALTA, Cmax and AUC values were approximately 100% greater inpatients with end stage renal disease receiving chronic intermittent hemodialysis than in subjects with normal renal fuction. The elimination half-life, however, was similar in both groups. The AUC’s of the major circulation metabolites, 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate, largely excreted in urine, were approximately 7 – to 9 – fold higher and would be expected to increase further with multiple dosing. For this reason, CYMBALTA is not recommended for patients with ESRD (see DOSAGE AND ADMINISTATION). Studies have not been conducted in patients with a moderate degree of renal dysfunction, but population PK analyses suggest that mild renal dysfunction has no significant effect on CYMBALTA apparent clearance.

Hepatic Insufficiency – Patients with clinically evident hepatic insufficiency have decreased CYMBALTA metabolism and elimination. After a single 20-mg dose of CYMBALTA 6 cirrhotic patients with moderate liver impairment (Child-Pugh Class B) had a mean plasma CYMBALTA clearance about 15% that of age- and gender-matched healthy subjects, with a 5-fold increase in mean exposure (AUC). Although Cmax was similar to normals in the cirrhotic patients, the half-life was about 3 times longer (see PRECAUTIONS). It is recommended that CYMBALTA no be administered to patients with any hepatic insufficiency (see DOSAGE AND ADMINISTRATION).   Back to top of page

Drug-Drug Interactions (also see PRECAUTIONS, Drug Interactions)

Potential for Other Drugs to Affect CYMBALTA.

  Both CYP1A2 and CYP2D6 are responsible for CYMBALTA metabolism.

INDICATIONS AND USAGE

CYMBALTA is indicated for the treatment of major depressive disorder (MDD).

CONTRAINDICATIONS

Hypersensitivity

CYMBALTA is contraindicated in patients with a known hypersensitivity to the product.

WARNINGS Back to top of page

  Clinical Worsening and Suicide Risk – Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there was been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases of decreases.  Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or whose emergent suicidality is severe, abrupt in onset, or was not part of the patient’s presenting symptoms.

  Because of the possibility of co-morbidity between major depressive disorder and other psychiatric and nonpsychiatric disorders, the same precautions observed when treating patients with major depressive disorder should be observed when treating patients with other psychiatric and nonpsychiatric disorders.

  The following symptoms – anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania – have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medications, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

  Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of suicidality, and to report such symptoms immediately to health care providers. Prescriptions for CYMBALTA should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.

  If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION, Discontinuing CYMBALTA (duloxetine hydrochloride), for a description  of the risks of discontinuation of CYMBALTA).

Information of Patients Back to top of page

  Physicians are advised to discuss the following issues with patients for whom they prescribe CYMBALTA.

  Patients and their families should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania, worsening of depression, and suicidal ideation, especially early during antidepressant treatment. Such symptoms should be reported to the patient’s physician, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

  Any psychoactive drug may impair judgment, thinking, or motor skills.

Drug Interactions (also see CLINICAL PHARMACOLOGY, Drug – Drug

Interactions)

  Inhibitors of CYP2D6 – Because CYP2D6 is involved in CYMBALTA metabolism, concomitant use of CYMBALTA with potent inhibitors of CYP2D6 may result in higher concentrations of CYMBALTA. Paroxetine (20 mg QD) increased the concentration of CYMBALTA (40 mg QD) by about 60%, and greater degrees of inhibition are expected with higher doses of Paroxetine. Similar effect would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine).

 ADVERSE REACTIONS Back to top of page

  CYMBALTA has been evaluated for safety in 2418 patients diagnosed with major depressive disorder who participated in multiple-dose premarketing trials, representing 1099 patient-years of exposure. Among these 2418 CYMBALTA treated patients, 1139 patients participated in eight 8- or 9- week, placebo-controlled trials at doses ranging from 40 to 120 mg/day, while the remaining 1279 patients were followed for up to 1 year in an open-label safety study using flexible doses from 80 to 120 mg/day. Two placebo-controlled studies with doses of 80 to 120 mg/day had 6- month maintenance extensions. Of these 2418 patients, 993 CYMBALTA-treated patients were exposed for at least 180 days and 445 CYMBALTA-treated patients were exposed for at least 1 year. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

  Clinical investigators recorded adverse events using descriptive terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing adverse events, grouping similar types of events into a smaller number of standardized event categories is necessary. In the tables and tabulations that follow, MedDRA terminology has been used to classify reported adverse events.

  The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Events reported during the studies were not necessarily caused by the therapy, and the frequencies do not reflect investigator impression (assessment) of causality.

  The cited figures provide the prescriber with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied. The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.

Adverse Events Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials

  Approximately 10% of the 1139 patients who received CYMBALTA in the placebo-controlled trials discontinued treatment due to an adverse event, compared with 4% of the 777 patients receiving placebo. Nausea (CYMBALTA 1.4%, placebo 0.1%) was the only common adverse event reported as reason for discontinuation and considered to be drug-related (i.e., discontinuation occurring in at least 1% of the CYMBALTA-treated patients and at a rate of at least twice that of placebo).

Adverse Events Occurring at an Incidence of 2% or More Among CYMBALTA-Treated Patients in Placebo-Controlled Trials Back to top of page

  Table 1 gives the incidence of treatment-emergent adverse events that occurred in 2% or more of patients treated with CYMBALTA in the acute phase of MDD placebo-controlled trials and with an incidence greater than placebo. The most commonly observed adverse events in CYMBALTA-treated MDD patients (incidence of 5% or greater and at least twice the incidence in placebo patients) were nausea; dry mouth; constipation; decreased appetite; fatigue; somnolence; and increased sweating.

Effects on Male and Female Sexual Function

  Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.

Other Adverse Events Observed During the Premarketing Evaluation of CYMBALTA

  Following is a list of modified MedDRA terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with CYMBALTA at multiple doses throughout the dose range studied during any phase of a trial within the premarketing database. The events included are those not already listed elsewhere in ADVERSE REACTIONS and not considered in the WARNINGS and PRECAUTIONS sections, that were reported with an incidence of greater than or equal to 0.05%, are not common as background events and were considered possibly drug related (e.g., because of the drug’s pharmacology) or potentially important. Back to top of page

  It is important to emphasize that, although the events reported occurred during treatment with CYMBALTA, they were not necessarily caused by it. Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

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

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

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

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

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

  Vascular DisordersInfrequent: peripheral edema and phlebitis.

Discontinuing CYMBALTA (duloxetine hydrochloride) Back to top of page

  Symptoms associated with discontinuation of CYMBALTA and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

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