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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 Side Effects
This site gives basic information about Cymbalta and other psychoactive medication.
If you are looking for information or assistance regarding:
What can you do to eliminate withdrawal side effects or general side effects caused by Cymbalta?
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The book offers step-by-step solutions and much more.
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“I am now more than halfway off my antidepressant, using the program. I was able to reduce a little bit of the medication with my naturopath, but we reached a standstill after the second reduction. The side effects started and we could not get rid of them. The Omega 3 got rid of the brain zaps within a few hours and they never came back. The Body Calm has been amazing at helping me stay calm during the day and with my sleep. And that barley did just what you said it would do for my energy and complete feelings. I can’t thank you enough.”
J.S.
New YorkBelow is a list of Cymbalta withdrawal side effects. These Cymbalta side effects can occur while taking the Cymbalta before withdrawal or may become apparent once Cymbalta withdrawal begins. It is imperative you use a Cymbalta withdrawal plan designed to eliminate or reduce Cymbalta withdrawal side effects. Once Cymbalta withdrawal side effects begin, they are more difficult to get rid of.
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.
- Cymbalta withdrawal - Anorexia – No longer having a desire to eat.
- Cymbalta withdrawal - Apothous Stomatitis – Painful red and swollen
open sores on a mucus membrane of the mouth commonly called a canker sore.
- Cymbalta withdrawal - Ataxia – Loss of the ability to move the body
with coordination.
- 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.
- 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.
- 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.
- 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.
- Cymbalta withdrawal - Cardiac Failure – A heart disorder where the
heart does not function as usual and may completely stop working.
- 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.
- 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.
- Cymbalta withdrawal - Colitis – A condition where the large intestine
becomes irritated from the use of the drug.
- 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.
- 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.
- 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.
- 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.
- Cymbalta withdrawal - Dysarthria – The inability to control the mouth
muscles when forming words so the words are not clearly spoken and heard.
- Cymbalta withdrawal - Dyslipidemia – The normal fat metabolism in the
blood is interfered with.
- Cymbalta withdrawal - Dysphagia – Trouble swallowing or the inability
to swallow.
- Cymbalta withdrawal - Ecchymosis – When a blood vessel breaks and
creates a purple discoloration of the skin.
- Cymbalta withdrawal - Edema – An abnormal build up of excess fluids
in the cells, tissues, and the spaces between the tissues creating swelling.
- 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.
- 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.
- 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.
- 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.
- Cymbalta withdrawal - Erythema – a skin redness caused by the
swelling with blood of the tiny blood vessels of the skin as in burns.
- 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).
- Cymbalta withdrawal - Esophageal Stenosis Acquired – The tube that
moves food from the mouth to the stomach narrows.
- Cymbalta withdrawal - Exfoliative Dermatitis – The unusual and not
normal condition of scaling and shedding of the skin cells. The skin is
usually red colored.
- Cymbalta withdrawal - Face Edema – The tissues of the face become
swollen.
- Cymbalta withdrawal - Feeling Jittery – A physical sensation of
nervous unease.
- Cymbalta withdrawal - Gastric Irritation – An inflamed and sore
stomach.
- Cymbalta withdrawal - Gastric Ulcer – An open, irritated, and
infected sore in the wall of the stomach.
- Cymbalta withdrawal - Gingivitis – Sore, swollen and red gums in the
mouth that bleed easily.
- 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.
- Cymbalta withdrawal - Hepatic Steatosis – Excessive amounts of fat in
the liver.
- 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.
- Cymbalta withdrawal - Hyperkeratosis – An abnormal enlargement of the
skin tissues causing the skin cells to increase in size.
- Cymbalta withdrawal - Hyperlipidemia – An abnormally high number of
fat cells in the blood.
- 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.
- Cymbalta withdrawal - Hypoesthesia – A partial loss of sensation or
general loss of awareness.
- 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.
- 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.
- 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.
- 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.
- 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.
- Cymbalta withdrawal - Leukopenia – An unnaturally low number of white
blood cells circulating in the blood.
- Cymbalta withdrawal - Loose Stools – The bowel movement is runny
instead of formed.
- 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.
- 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.
- Cymbalta withdrawal - Macular Degeneration – The gradual loss of
central vision, which is the sharpest vision while peripheral eyesight, is
unaffected.
- 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.
- Cymbalta withdrawal - Mania – Unusually irrational, excessive and/or
exaggerated behavior or moods ranging from enthusiasm, sexuality, gaiety,
impulsiveness and irritability to violence.
- 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.
- Cymbalta withdrawal - Micturition Urgency – A sudden desire to
urinate usually followed by leakage.
- Cymbalta withdrawal - Mood Swings – An emotional shifting as from a
state of happiness to a state of depression for a period of time.
- Cymbalta withdrawal - Myocardial Infarction – The blood going to the
heart is delayed or stopped causing middle muscle tissue in the heart wall
to die.
- 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.
- Cymbalta withdrawal - Nephropathy – An abnormally functioning or
diseased kidney.
- Cymbalta withdrawal - Nervousness – Jumpy, jittery, anxious, and
troubled with an irritable temperament.
- 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.
- Cymbalta withdrawal - Nightmare – Dreams that make you afraid or
leave feelings of fear, terror, and upset long after waking up.
- Cymbalta withdrawal - Orgasm Abnormal – Unable to have an orgasm with
normal sexual stimulation.
- 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.
- Cymbalta withdrawal - Pain in Extremity – A painful feeling in the
legs, arms, hands, and feet.
- 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.
- Cymbalta withdrawal - Photopsia – A condition where a person see
lights, sparks or colors in front of your eyes.
- Cymbalta withdrawal - Photosensitivity Reaction – An exaggerated
sunburn reaction that is not normal in proportion to the amount of exposure
to the light.
- Cymbalta withdrawal - Pollakiuria – Urinating much more frequently
than normal – as often as once every five to fifteen minutes.
- 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.
- Cymbalta withdrawal - Pruritic Rash – Extremely itchy, red, swollen
bumps on the skin.
- Cymbalta withdrawal - Pyrexia – Fever or the increase in body
temperature that is usually a sign of infection.
- 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.
- Cymbalta withdrawal - Rigors – Shivering or shaking of the body as if
chilled, preventing normal responses.
- Cymbalta withdrawal - Skin Ulcer – An open sore or infected skin
eruption with swelling, redness, pus, and irritation.
- 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.
- Cymbalta withdrawal - Suicide, Completed – An attempted attack on
oneself that is life threatening results in death.
- 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.
- Cymbalta withdrawal - Urinary Hesitation – Hard to start or hard to
continue emptying one’s bladder.
- 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.
- 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.
- Cymbalta withdrawal - Urine Flow Decreased – Dehydration of the body
causing a lesser flow of urine than normal with the body reabsorbing the
waste.
- Cymbalta withdrawal - Urine Output Decreased – A condition where the
output of urine produced in a 24-hour period is less than 500 ml.
- Cymbalta withdrawal - Weight Decreased – Unintentional weight loss.
- Cymbalta withdrawal – Weight Increased – An unusual, usually rapid weight increase.
Cymbalta Clinical Trials
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dysphoric disorder: a single-blind trial.
Ramos MG, Hara C, Rocha FL.
Int J Neuropsychopharmacol. 2009 Feb 27:1-8. [Epub
ahead of print]
PMID: 19250561 [PubMed - as supplied
by publisher]
When worlds collide: urinary incontinence and female
sexuality.
Katz A.
Am J Nurs. 2009 Mar;109(3):59-63. Review. No
abstract available.
PMID: 19240500 [PubMed - indexed for
MEDLINE]
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.
PMID: 19229839 [PubMed - in process]
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.
PMID: 19228176 [PubMed - indexed for
MEDLINE]
Fibromyalgia: presentation and management with a
focus on pharmacological treatment.
Sumpton JE, Moulin DE.
Pain Res Manag. 2008 Nov-Dec;13(6):477-83. Review.
PMID: 19225604 [PubMed - indexed for
MEDLINE]
A validated stability indicating rapid LC method for
duloxetine HCl.
Srinivasulu P, Srinivas KS, Reddy RS, Mukkanti K,
Buchireddy R.
Pharmazie. 2009 Jan;64(1):10-3.
PMID: 19216224 [PubMed - indexed for
MEDLINE]
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.
PMID: 19210951 [PubMed - indexed for
MEDLINE]
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.
PMID: 19210191 [PubMed - indexed for
MEDLINE]
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.
PMID: 19210149 [PubMed - indexed for
MEDLINE]
Serious suicide attempt with duloxetine treatment.
Reeves RR, Brister JC.
South Med J. 2008 Jul;101(7):769. No abstract
available.
PMID: 19209119 [PubMed - indexed for
MEDLINE]
Quilici S, Chancellor J, Löthgren M, Simon D, Said
G, Le TK, Garcia-Cebrian A, Monz B.
BMC Neurol. 2009 Feb 10;9:6.
PMID: 19208243 [PubMed - indexed for
MEDLINE]
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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.
PMID: 19204654 [PubMed - in process]
Volpe FM.
J Clin Psychiatry. 2008 Sep;69(9):1449-54.
PMID: 19193344 [PubMed - indexed for
MEDLINE]
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.
PMID: 19193339 [PubMed - indexed for
MEDLINE]
Chaves AR, Chiericato Júnior G, Queiroz ME.
J Chromatogr B Analyt Technol Biomed Life Sci. 2009
Mar 1;877(7):587-93. Epub 2009 Jan 16.
PMID: 19185550 [PubMed - indexed for
MEDLINE]
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.
PMID: 19185342 [PubMed - indexed for
MEDLINE]
[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.
PMID: 19183930 [PubMed - in process]
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.
Neuropsychiatr Dis Treat. 2008 Oct;4(5):929-35.
PMID: 19183783 [PubMed - in process]
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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.
PMID: 19173371 [PubMed - indexed for
MEDLINE]
Munro G.
Eur J Pharmacol. 2009 Mar 1;605(1-3):95-102. Epub
2009 Jan 11.
PMID: 19168051 [PubMed - in process]
Furuta A, Asano K, Egawa S, de Groat WC, Chancellor
MB, Yoshimura N.
J Urol. 2009 Mar;181(3):1467-73. Epub 2009 Jan 20.
PMID: 19157445 [PubMed - indexed for
MEDLINE]
Long-Term Safety, Tolerability, and Efficacy of
Duloxetine in the Treatment of Fibromyalgia.
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]
PMID: 19152958 [PubMed - as supplied
by publisher]
Wasan AD, Ossanna MJ, Raskin J, Wernicke JF,
Robinson MJ, Hall JA, Edwards SE, Lipsius S, Meyers AL, McCarberg BH.
Curr Drug Saf. 2009 Jan;4(1):22-9.
PMID: 19149522 [PubMed - indexed for
MEDLINE]
Llorca PM, Bodkin JA, Spann M, Ball SG, Russell JM,
Ball SG.
J Clin Psychopharmacol. 2009 Feb;29(1):96-7. No
abstract available.
PMID: 19142122 [PubMed - indexed for
MEDLINE]
Voznesenskaia TG.
Zh Nevrol Psikhiatr Im S S Korsakova.
2008;108(11):98-101. Russian. No abstract available.
PMID: 19137666 [PubMed - indexed for
MEDLINE]
Duloxetine for the treatment of fibromyalgia.
Acuna C.
Drugs Today (Barc). 2008 Oct;44(10):725-34. Review.
PMID: 19137126 [PubMed - indexed for
MEDLINE]
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.
PMID: 19128810 [PubMed - in process]
Central sensitisation phenomena in primary
headaches: overview of a preventive therapeutic approach.
de Tommaso M, Sardaro M, Vecchio E, Serpino C,
Stasi M, Ranieri M.
CNS Neurol Disord Drug Targets. 2008
Dec;7(6):524-35.
PMID: 19128209 [PubMed - in process]
Fibromyalgia coverage uneven despite recent drug
approvals.
Sipkoff M.
Manag Care. 2008 Dec;17(12):9-10. No abstract
available.
PMID: 19127758 [PubMed - indexed for
MEDLINE]
Melo LP, Nogueira AM, Lanças FM, Queiroz ME.
Anal Chim Acta. 2009 Feb 2;633(1):57-64. Epub 2008
Nov 25.
PMID: 19110116 [PubMed - indexed for
MEDLINE]
Perlis RH, Fijal B, Adams DH, Sutton VK, Trivedi
MH, Houston JP.
Biol Psychiatry. 2009 May 1;65(9):785-91. Epub 2008
Dec 18.
PMID: 19095219 [PubMed - in process]
Tomillero A, Moral MA.
Methods Find Exp Clin Pharmacol. 2008
Oct;30(8):643-72.
PMID: 19088949 [PubMed - indexed for
MEDLINE]
Effect of desvenlafaxine on the cytochrome P450 2D6
enzyme system.
Preskorn SH, Nichols AI, Paul J, Patroneva AL,
Helzner EC, Guico-Pabia CJ.
J Psychiatr Pract. 2008 Nov;14(6):368-78. Review.
PMID: 19057238 [PubMed - indexed for
MEDLINE]
Howland RH, Wilson MG, Kornstein SG, Clayton AH,
Trivedi MH, Wohlreich MM, Fava M.
Ann Clin Psychiatry. 2008 Oct-Dec;20(4):209-18.
PMID: 19034753 [PubMed - indexed for
MEDLINE]
The effect of pain on outcomes in a trial of
duloxetine treatment of major depressive disorder.
Arnold LM, Meyers AL, Sunderajan P, Montano CB,
Kass E, Trivedi M, Wohlreich MM.
Ann Clin Psychiatry. 2008 Oct-Dec;20(4):187-93.
PMID: 19034749 [PubMed - indexed for
MEDLINE]
Prioritizing future research on off-label
prescribing: results of a quantitative evaluation.
Walton SM, Schumock GT, Lee KV, Alexander GC,
Meltzer D, Stafford RS.
Pharmacotherapy. 2008 Dec;28(12):1443-52.
PMID: 19025425 [PubMed - indexed for
MEDLINE]
Molteni R, Calabrese F, Cattaneo A, Mancini M,
Gennarelli M, Racagni G, Riva MA.
Neuropsychopharmacology. 2009 May;34(6):1523-32.
Epub 2008 Nov 19.
PMID: 19020498 [PubMed - in process]
Gartlehner G, Gaynes BN, Hansen RA, Thieda P,
DeVeaugh-Geiss A, Krebs EE, Moore CG, Morgan L, Lohr KN.
Ann Intern Med. 2008 Nov 18;149(10):734-50. Review.
PMID: 19017592 [PubMed - indexed for
MEDLINE]
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Qaseem A, Snow V, Denberg TD, Forciea MA, Owens DK;
Clinical Efficacy Assessment Subcommittee of American College of Physicians.
Ann Intern Med. 2008 Nov 18;149(10):725-33. Erratum
in: Ann Intern Med. 2009 Jan 20;150(2):148.
PMID: 19017591 [PubMed - indexed for
MEDLINE]
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A cost-utility comparison of four first-line
medications in painful diabetic neuropathy.
O'Connor AB, Noyes K, Holloway RG.
Pharmacoeconomics. 2008;26(12):1045-64. doi:
10.2165/0019053-200826120-00007.
PMID: 19014205 [PubMed - indexed for
MEDLINE]
Antidepressant-induced sweating alleviated by
aripiprazole.
Lu BY, Cullen CE, Eide CE, Williams CC, Apfeldorf
WJ.
J Clin Psychopharmacol. 2008 Dec;28(6):710-1. No
abstract available.
PMID: 19011447 [PubMed - indexed for
MEDLINE]
Successful duloxetine treatment of a binge eating
disorder: a case report.
Bernardi S, Pallanti S.
J Psychopharmacol. 2008 Nov 14. [Epub ahead of
print]
PMID: 19010975 [PubMed - as supplied
by publisher]
Rane VP, Shinde DB.
J Chromatogr Sci. 2008 Oct;46(9):772-6.
PMID: 19007477 [PubMed - indexed for
MEDLINE]
Tomillero A, Moral MA.
Methods Find Exp Clin Pharmacol. 2008
Sep;30(7):543-88.
PMID: 18985183 [PubMed - indexed for
MEDLINE]
First pregabalin and now duloxetine for fibromyalgia
syndrome: closer to a brave new world?
Boomershine CS.
Nat Clin Pract Rheumatol. 2008 Dec;4(12):636-7.
Epub 2008 Nov 4. No abstract available.
PMID: 18982001 [PubMed]
A single-blind, placebo run-in study of duloxetine
for activity-limiting osteoarthritis pain.
Sullivan MD, Bentley S, Fan MY, Gardner G.
J Pain. 2009 Feb;10(2):208-13. Epub 2008 Oct 31.
PMID: 18976962 [PubMed - indexed for
MEDLINE]
Pereira P, Gianesini J, da Silva Barbosa C, Cassol
GF, Von Borowski RG, Kahl VF, Cappelari SE, Picada JN.
Pharmacol Res. 2009 Jan;59(1):57-61. Epub 2008 Oct
5.
PMID: 18973814 [PubMed - indexed for
MEDLINE]
Holman AJ.
Curr Pain Headache Rep. 2008 Dec;12(6):393-8.
Review.
PMID: 18973730 [PubMed - indexed for
MEDLINE]
Soni P, Mariappan TT, Banerjee UC.
Talanta. 2005 Oct 31;67(5):975-8.
PMID: 18970267 [PubMed - in process]
Postprostatectomy Incontinence: All About Diagnosis
and Management.
Bauer RM, Bastian PJ, Gozzi C, Stief CG.
Eur Urol. 2008 Oct 23. [Epub ahead of print]
PMID: 18963418 [PubMed - as supplied
by publisher]
[Dermatological side effects during therapy with
serotonin noradrenaline reuptake inhibitors]
Gross CM, Klöcker M, Jakob T, Klecha D.
Nervenarzt. 2008 Nov;79(11):1304, 1307-9. German.
PMID: 18958440 [PubMed - indexed for
MEDLINE]
Wade AG, Schlaepfer TE, Andersen HF, Kilts CD.
J Psychiatr Res. 2009 Feb;43(5):568-75. Epub 2008
Oct 26.
PMID: 18954875 [PubMed - indexed for
MEDLINE]
[Combination of Dialectical Behavioral Therapy (DBT)
and Duloxetin in Kleptomania.]
Rudel A, Hubert C, Juckel G, Edel MA.
Psychiatr Prax. 2008 Oct 15. [Epub ahead of print]
German.
PMID: 18924062 [PubMed - as supplied
by publisher]
Is duloxetine effective treatment for depression
with atypical features?
Stewart JW, Deliyannides DA, McGrath PJ.
Int Clin Psychopharmacol. 2008 Nov;23(6):333-6.
PMID: 18854721 [PubMed - indexed for
MEDLINE]
Clinical impact of duloxetine treatment on sleep in
patients with major depressive disorder.
Brecht S, Kajdasz D, Ball S, Thase ME.
Int Clin Psychopharmacol. 2008 Nov;23(6):317-24.
PMID: 18854719 [PubMed - indexed for
MEDLINE]
Duloxetine and pregabalin: safe and effective for
the long-term treatment of fibromyalgia?
Serra E.
Nat Clin Pract Neurol. 2008 Nov;4(11):594-5. Epub
2008 Oct 14.
PMID: 18852724 [PubMed]
Wade AG, Fernández JL, François C, Hansen K,
Danchenko N, Despiegel N.
Pharmacoeconomics. 2008;26(11):969-81.
PMID: 18850765 [PubMed - indexed for
MEDLINE]
Efficacy, tolerability, and safety of duloxetine.
Wise TN.
CNS Spectr. 2005 Dec;10(12 Suppl 19):10-1. Review.
No abstract available.
PMID: 18841598 [PubMed - indexed for
MEDLINE]
Sheehan DV, Keene MS, Eaddy M, Krulewicz S, Kraus
JE, Carpenter DJ.
CNS Drugs. 2008;22(11):963-73.
PMID: 18840035 [PubMed - indexed for
MEDLINE]
Englisch S, Fritzinger M, Zink M.
Clin Neuropharmacol. 2008 Sep-Oct;31(5):307-9.
PMID: 18836353 [PubMed - indexed for
MEDLINE]
Hansen R, Gaynes B, Thieda P, Gartlehner G,
Deveaugh-Geiss A, Krebs E, Lohr K.
Psychiatr Serv. 2008 Oct;59(10):1121-30.
PMID: 18832497 [PubMed - indexed for
MEDLINE]
New treatment options for fibromyalgia: critical
appraisal of duloxetine.
Uçeyler N, Offenbächer M, Petzke F, Häuser W,
Sommer C.
Neuropsychiatr Dis Treat. 2008 Jun;4(3):525-9.
PMID: 18830399 [PubMed - in process]
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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]
PMID: 18828958 [PubMed - as supplied
by publisher]
Multiplicative interactions to enhance gabapentin to
treat neuropathic pain.
Hayashida K, Eisenach JC.
Eur J Pharmacol. 2008 Nov 19;598(1-3):21-6. Epub
2008 Sep 17.
PMID: 18822281 [PubMed - indexed for
MEDLINE]
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.
PMID: 18809731 [PubMed - in process]
Tomillero A, Moral MA.
Methods Find Exp Clin Pharmacol. 2008
Jun;30(5):383-408.
PMID: 18806898 [PubMed - indexed for
MEDLINE]
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.
PMID: 18801947 [PubMed - indexed for
MEDLINE]
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.
PMID: 18798992 [PubMed - in process]
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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.
PMID: 18797690 [PubMed - in process]
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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.
PMID: 18794669 [PubMed - indexed for
MEDLINE]
Moore RA, Derry S, McQuay HJ.
Pain. 2008 Oct 15;139(2):477-9; author reply
479-80. Epub 2008 Sep 13. No abstract available.
PMID: 18790568 [PubMed - indexed for
MEDLINE]
Wise TN, Meyers AL, Desaiah D, Mallinckrodt CH,
Robinson MJ, Kajdasz DK.
Prim Care Companion J Clin Psychiatry.
2008;10(4):270-5.
PMID: 18787676 [PubMed - in process]
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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.
PMID: 18785947 [PubMed - indexed for
MEDLINE]
Duloxetine for neuropathic pain based on recent
clinical trials.
Fishbain D, Berman K, Kajdasz DK.
Curr Pain Headache Rep. 2006 Jun;10(3):199-204.
Review.
PMID: 18778574 [PubMed - indexed for
MEDLINE]
Update on pharmacotherapy guidelines for the
treatment of neuropathic pain.
Dobecki DA, Schocket SM, Wallace MS.
Curr Pain Headache Rep. 2006 Jun;10(3):185-90.
Review.
PMID: 18778572 [PubMed - indexed for
MEDLINE]
[No authors listed]
APMIS Suppl. 2008;(124):66-9.
PMID: 18771102 [PubMed - indexed for
MEDLINE]
Wernicke JF, Prakash A, Kajdasz DK, Houston J.
J Diabetes Complications. 2008 Sep 1. [Epub ahead
of print]
PMID: 18768332 [PubMed - as supplied
by publisher]
A systematic review on the effectiveness of
treatment with antidepressants in fibromyalgia syndrome.
Uçeyler N, Häuser W, Sommer C.
Arthritis Rheum. 2008 Sep 15;59(9):1279-98. Review.
PMID: 18759260 [PubMed - indexed for
MEDLINE]
Muneoka K, Shirayama Y, Takigawa M, Shioda S.
Neurochem Res. 2009 Mar;34(3):542-55. Epub 2008 Aug
27.
PMID: 18751896 [PubMed - indexed for
MEDLINE]
Duloxetine-associated tachycardia.
Stevens DL.
Ann Pharmacother. 2008 Oct;42(10):1511-3. Epub 2008
Aug 26.
PMID: 18728105 [PubMed - indexed for
MEDLINE]
Bellino S, Paradiso E, Bozzatello P, Bogetto F.
J Psychopharmacol. 2008 Nov 21. [Epub ahead of
print]
PMID: 18719047 [PubMed - as supplied
by publisher]
Dekeyne A, Millan MJ.
Psychopharmacology (Berl). 2009 Apr;203(2):329-41.
Epub 2008 Aug 16.
PMID: 18709360 [PubMed - in process]
Perahia DG, Quail D, Desaiah D, Montejo AL,
Schatzberg AF.
J Psychiatr Res. 2009 Feb;43(5):512-8. Epub 2008
Aug 15.
PMID: 18707693 [PubMed - indexed for
MEDLINE]
Molteni R, Calabrese F, Mancini M, Racagni G, Riva
MA.
Psychopharmacology (Berl). 2008 Dec;201(2):285-92.
Epub 2008 Aug 14.
PMID: 18704370 [PubMed - indexed for
MEDLINE]
Wells KA, Losin WG.
Clin Ther. 2008 Jul;30(7):1300-8.
PMID: 18691989 [PubMed - indexed for
MEDLINE]
Spina E, Santoro V, D'Arrigo C.
Clin Ther. 2008 Jul;30(7):1206-27. Review.
PMID: 18691982 [PubMed - indexed for
MEDLINE]
Hepatic Effects of Duloxetine-III: Analysis of
Hepatic Events Using External Data Sources.
Strombom I, Wernicke JF, Seeger J, D'Souza DN,
Acharya N.
Curr Drug Saf. 2008 May;3(2):154-62.
PMID: 18690993 [PubMed - in process]
Hepatic Effects of Duloxetine-II: Spontaneous
Reports and Epidemiology of Hepatic Events.
Wernicke J, Acharya N, Strombom I, Gahimer JL,
D'Souza DN, Dipietro N, Uetrecht JP.
Curr Drug Saf. 2008 May;3(2):143-53.
PMID: 18690992 [PubMed - in process]
Hepatic effects of duloxetine-I: non-clinical and
clinical trial data.
Wernicke J, Pangallo B, Wang F, Murray I, Henck JW,
Knadler MP, D'Souza DN, Uetrecht JP.
Curr Drug Saf. 2008 May;3(2):132-42.
PMID: 18690991 [PubMed - in process]
Tolerability of amine uptake inhibitors in urologic
diseases.
Michel MC, Ruhe HG, de Groot AA, Castro R, Oelke M.
Curr Drug Saf. 2006 Jan;1(1):73-85. Review.
PMID: 18690917 [PubMed - indexed for
MEDLINE]
Fibromyalgia syndrome: a relevant recent
construction of an ancient condition?
Perrot S.
Curr Opin Support Palliat Care. 2008
Jun;2(2):122-7. Review.
PMID: 18685409 [PubMed - indexed for
MEDLINE]
Measurement of pain and medication effect in a study
of duloxetine.
Griffith JM, Hasley JP, Severn DG.
J Clin Psychiatry. 2008 Jun;69(6):1022. No abstract
available.
PMID: 18684005 [PubMed - indexed for
MEDLINE]
A case of apical ballooning cardiomyopathy
associated with duloxetine.
Bergman BR, Reynolds HR, Skolnick AH, Castillo D.
Ann Intern Med. 2008 Aug 5;149(3):218-9. No
abstract available.
PMID: 18678857 [PubMed - indexed for
MEDLINE]
Sultan A, Gaskell H, Derry S, Moore RA.
BMC Neurol. 2008 Aug 1;8:29. Review.
PMID: 18673529 [PubMed - indexed for
MEDLINE]
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Are SNRIs More Effective than SSRIs? A Review of the
Current State of the Controversy.
Thase ME.
Psychopharmacol Bull. 2008;41(2):58-85.
PMID: 18668017 [PubMed - in process]
Sheehan DV, Meyers AL, Prakash A, Robinson MJ,
Swindle RW, Russell JM, Mallinckrodt CH.
Curr Med Res Opin. 2008 Sep;24(9):2457-66. Epub
2008 Jul 24.
PMID: 18662492 [PubMed - indexed for
MEDLINE]
Duloxetine (cymbalta) for fibromyalgia.
[No authors listed]
Med Lett Drugs Ther. 2008 Jul 28;50(1291):57-8. No
abstract available.
PMID: 18654110 [PubMed - indexed for
MEDLINE]
Answers to the most common questions about the
hepatic safety profile of duloxetine.
Wohlreich MM, Acharya N, Strombom I, Kuritzky L,
Robinson M, Heinloth AN, Regev A, Wernicke JF.
Postgrad Med. 2008 Jul;120(2):111-8. Review.
PMID: 18654076 [PubMed - indexed for
MEDLINE]
Duloxetine: a new psychopharmacologic treatment
option for fibromyalgia?
Pae CU, Masand P.
Curr Psychiatry Rep. 2008 Jun;10(3):237-9. No
abstract available.
PMID: 18652792 [PubMed]
The influence of smoking on the serum level of
duloxetine.
Fric M, Pfuhlmann B, Laux G, Riederer P, Distler G,
Artmann S, Wohlschläger M, Liebmann M, Deckert J.
Pharmacopsychiatry. 2008 Jul;41(4):151-5.
PMID: 18651344 [PubMed - indexed for
MEDLINE]
Kornstein SG, Dunner DL, Meyers AL, Whitmyer VG,
Mallinckrodt CH, Wohlreich MM, Detke MJ, Hollandbeck MS, Greist JH.
J Clin Psychiatry. 2008 Jul 15:e1-e10. [Epub ahead
of print]
PMID: 18642978 [PubMed - as supplied
by publisher]
Volpe FM.
J Clin Psychiatry. 2008 Jul 15:e1-e6. [Epub ahead
of print]
PMID: 18642977 [PubMed - as supplied
by publisher]
Allgulander C, Nutt D, Detke M, Erickson J, Spann
M, Walker D, Ball SG, Russell JM.
J Psychopharmacol. 2008 Jun;22(4):417-25.
PMID: 18635722 [PubMed - indexed for
MEDLINE]
Nutt D, Allgulander C, Lecrubier Y, Peters T,
Wittchen U.
J Psychopharmacol. 2008 Jun;22(4):409-16.
PMID: 18635721 [PubMed - indexed for
MEDLINE]
Wine and drug evaluations: lessons on making
comparisons of noninferiority.
Allgulander C, Nutt DJ.
J Psychopharmacol. 2008 Jun;22(4):341-2. No
abstract available.
PMID: 18635714 [PubMed - indexed for
MEDLINE]
Shock-like sensations associated with duloxetine
discontinuation.
Pitchot W, Ansseau M.
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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 Disorders – Frequent: 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 Disorders – Frequent: 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 Disorders – Infrequent: 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.