In the first four months of 2013, Cymbalta sales amounted to $1.3 billion. This relatively new antidepressant is now the third most prescribed drug in the United States with about 25 million bottles of it sold a year.[i]
The big pharmacy companies that make Cymbalta and similar drugs use careful language when they describe them in their brochures. They are clear that Cymbalta is not addictive. Animals don’t beat down their cage doors to get it — the way they do to get cocaine. People don’t take Cymbalta to get high — the way they take LSD or marijuana. They don’t keep taking more to get the same effects — the way they do when they are addicted to heroin or alcohol.[ii]
In the strict sense of the definition, Cymbalta is therefore not addictive.
But what Big Pharma won’t tell you about this drug and similar anti-depressants is that many people who take them for any length of time develop a terrible “discontinuation” syndrome. The Internet is full of stories posted by people who “Went through months of hell,” “Lost my job and family,” and “Tried to end my own life” when they stopped taking Cymbalta. For some of them, symptoms of terrible anxiety, panic, brain “zaps,” insomnia, rages, and crying spells last for months, making them question their own sanity or causing them to attempt suicide. Other give up trying to get off these drugs because they are losing too much time from work or ruining their relationships with others. Those who suffered through “discontinuation syndromes” argue that no one adequately warned either them or their doctors that this could occur.
Heroin, alcohol, cocaine and other addictive substances produce withdrawal syndromes when you stop using them, and withdrawal is one component of any addiction. Over 50% of those who stop using Cymbalta develop symptoms, but let’s be clear that it is called “discontinuation syndrome.” Withdrawal sounds too much like addiction.
What is Cymbalta?
Cymbalta is the trademarked name of an anti-depressant drug called duloxetine. It is considered a “dual inhibitor” or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). SNRIs are probably more effective for most people than Selective Serotonin Reuptake Inhibitors (SSRIs) in that they increase the levels of both serotonin and norepinephrine in the brain and central nervous system. SSRIs only increase serotonin. Some common ones are Prozac, Paxil, Celexa and Zoloft. Besides Cymbalta, common SNRIs are Effexor and Pristiq.[iii]
Cymbalta probably increases not only the levels of serotonin and norepinephrine, but also noradrenalin and dopamine. These chemicals are naturally released during times of pleasure, relaxation, and joy. The chemical name for duloxetine is (+)-(S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine
The usual dose is 40mg to 60mg a day. People take up to 120mg daily, although there is no evidence that that a higher dosage is more effective than 60mg.[iv] Cymbalta comes as time-released capsules.
What are the Medical Uses of Cymbalta?
In 2001 the United States Food and Drug Administration found problems in approving Cymbalta because it can cause liver damage. The FDA finally approved Cymbalta in 2004 for use in the treatment of major depressive disorder and nerve pain from diabetes as long as its manufacturer, Eli Lilly, agreed to put a label warning patients about the danger of liver toxicity on the product. A year later the FDA approved Cymbalta for fibromyalgia but not for pain from arthritis. Cymbalta is not a pain reliever but an antidepressant, and it has not been approved for chronic pain,[v] although Eli Lilly will probably press to have it approved for all kinds of pain, so it could someday compete with aspirin, Tylenol and opioids.[vi]
In 2010 FDA officials wrote to the CEO of Eli Lilly, warning him that Cymbalta’s advertising appears false and misleading in that the drug is not a pain killer, and that Cymbalta ads understate the risks of taking this drug.[vii] Advertising for Cymbalta approaches $150 million a year.[viii]
Doctors also prescribe Cymbalta for general anxiety disorders, back pain, and chronic muscle and joint pain.[ix]
Cymbalta was approved for diabetic pain even though it increases fasting serum glucose, and some anecdotal evidence suggests it causes diabetes.[x]
One study found that between 40% and 45% of diabetics taking Cymbalta received a 50% reduction in pain compared to 20% taking a placebo. Since five to twenty percent of those in various Cymbalta trials drop out because of side effects, Cymbalta does not usually work much better than a placebo for the majority of patients. Some authorities, including Harvard professor Dr. Irving Kirsch, have done mega-analyses of all the various trials of antidepressants and have concluded that none of these drugs are very effective.[xi]
What are the Side Effects of Cymbalta?
The most common side effects are dizziness, sleepiness, nausea, dry mouth, fatigue, constipation, headache, decreased appetite and sweating.[xii] You should call your doctor if you develop certain serious side effects such as suicidal thoughts, aggression, worsening or new depression, insomnia, irritability or restlessness, unusual changes in mood or behavior,[xiii] unusual bleeding or bruising, hallucinations, fever, overactive reflexes, stiff muscles, confusion, tremors, or a feeling that you are about to pass out.[xiv]
Signs of liver damage from Cymbalta can be itching, pain in the right upper belly, dark urine, yellow skin and eyes, and flu-like symptoms. Consult your doctor right away if you have any of these symptoms.[xv]
Some people are allergic to Cymbalta and enter a life-threatening syndrome called anaphylactic shock when they take it. Symptoms can be severe skin reactions, sore throat, swelling in the face or tongue, burning eyes, rashes, and trouble breathing.[xvi] Allergic reactions require immediate medical attention.
What Drugs Interact with Cymbalta?
Cymbalta can cause life-threatening interactions with a variety of drugs. You increase your risk for overdose if you take Cymbalta with alcohol. Long-term use of this combination will cause severe liver damage.
Cymbalta plus the anti-psychotic drug Thioridazine can cause death.[xvii]
You should wait 14 days after you stop taking an MAO Inhibitor before taking Cymbalta because the combination can be deadly. Some names of these drugs are furazolidine, isocarboxazid, linezolid, phenelzine, rasagiline, seligiline, and tranylcypromine. Wait five days after you take a MAO Inhibitor to use Cymbalta.[xviii]
Common over-the-counter painkillers that affect bleeding such as aspirin, Aleve, and ibuprofen react with Cymbalta, as well as prescription painkillers like celecoxib, diclofenac, indomethacin, piroxicam, etodolac, and nabumetone.
Do not take Cymbalta with anything that depresses the central nervous system. In general, these are drugs that make you sleepy like sleeping pills, narcotics and muscle relaxants.[xix]
Do not take Cymbalta with blood thinners, certain antibiotics, medications for migraines, diuretics, lithium, St. John’s Wort, tramadol, other antidepressants, cimetidine, and buspirone. Cymbalta also interacts with many stimulants like phentermine, methamphetamine and cocaine.[xx]
What are the Dangers of Taking Cymbalta?
One of the main dangers of taking Cymbalta is liver damage, especially if you use it with alcohol or acetaminophen (Tylenol), or if you have an undiagnosed liver problem.
When people quit taking Cymbalta, over half develop “discontinuation syndromes,” and ten percent have severe symptoms that last weeks or even months.
A study from Duke University found that people with coronary heart disease were twice as likely to die within three years if they took antidepressants similar to Cymbalta.[xxi]
Although routinely prescribed for diabetic pain, Cymbalta may worsen diabetes in some patients.[xxii]
Does Cymbalta Show up on Urine Tests?
Routine urine tests at school and work do not detect Cymbalta, and it probably does not produce false positives for other drugs, despite anecdotal evidence.
Who Should Not Take Cymbalta?
People with glaucoma, liver and kidney diseases, seizures, blood clots or other bleeding diseases, high blood pressure, bipolar disorder, or histories of drug abuse and alcoholism should not take Cymbalta.[xxiii] People who are taking certain drugs, especially MAO Inhibitors, should not take Cymbalta. The manufacturer of this drug says that people with low sodium disorders and delayed stomach emptying should not take it.[xxiv]
Cymbalta is not prescribed to pregnant women because studies of its effects are inadequate. Similar drugs cause birth defects. Cymbalta will pass into the breast milk of nursing mothers.[xxv]
What is Cymbalta Overdose?
People have had serious problems after taking doses of just 1000mg of Cymbalta. However, the more common scenario is that the person being treated for overdose has ingested Cymbalta along with alcohol or other central nervous system depressants.[xxvi]
Symptoms of a Cymbalta overdose can be extreme sleepiness, vomiting, coma, too high or too low blood pressure, fainting, and seizures. Doctors will open the patient’s airways, administer oxygen and activated charcoal, and “pump” the stomach.[xxvii]
A patient may develop “serotonin syndrome,” a serious and life-threatening condition that occurs when the brain is flooded with the chemical serotonin. Symptoms can be serious and life-threatening, including hallucinations, fever, shivering, tremors, sweating, nausea, changes in blood pressure, and more. Treatment usually consists of benzodiazepines such as diazepam (Valium) or lorazepam (Ativan) to control agitation, seizure-like movements, and muscle stiffness, IV fluids, and/or Cyproheptadine (Periactin), a drug that blocks serotonin production.[xxviii]
What is Cymbalta Discontinuation Syndrome?
In one study done by Cymbalta’s manufacturer Eli Lilly, people who had been taking Cymbalta for eight or nine weeks were switched without their knowledge to an inactive placebo. About 44% developed “discontinuation syndrome,” and ten percent had severe symptoms. Half still had symptoms two weeks later, when the researchers stopped monitoring them.[xxix] Subsequent studies indicate that you are more likely to develop the syndrome if you stay on Cymbalta on a long-term basis, instead of just for the few months that were the norm in the study. For example, one study found that 60% of those who have been on it for two years or more developed symptoms, and some authorities put the rate at over 80%.[xxx]
Discontinuation syndrome most likely occurs because the cell receptors in the brain have to adjust to lower levels of serotonin and other chemicals.[xxxi] The Cymbalta discontinuation syndrome is more severe than most antidepressants because it leaves the bloodstream quickly. The longer-acting antidepressants naturally leave the body more slowly and therefore naturally cause fewer side effects.[xxxii]
The manufacturer of Cymbalta advises patients that “Stopping Cymbalta suddenly or reducing your dose may result in symptoms including dizziness, headache, or nausea (this is not a complete list). Your healthcare provider may want to decrease the dose slowly.”[xxxiii] Lawyers arguing for the plaintiffs in a lawsuit against Cymbalta are saying that this was an inadequate description of what really happens.[xxxiv] People have experienced such severe “dizziness” that they could not get out of bed. The majority also get “lightning bolt syndrome” or “brain zaps,” painful feelings like “electric shocks” that occur in the brain.[xxxv] Other symptoms reported to researchers are hallucinations, seizures, personality changes, sweating, nausea, blackouts, suicidal thoughts, tremors, irritability, agitation, extreme mood swings, emotional lability, ringing in the ears, hypomania, insomnia, and lethargy.[xxxvi]
What Treatment is Available for Cymbalta Discontinuation Syndrome?
The Institute for Safe Medication Practices, a non-profit organization that serves as a watchdog for consumers, reported in 2013 that Cymbalta ranked eighth among all drugs in the number of “alerts” and adverse events reported by patients. The Institute interprets these alerts as a “signal” that something should be done about helping patients who develop Cymbalta discontinuation syndromes.[xxxvii] Their researchers concluded that patients and their doctors do not get adequate information about what occurs during discontinuation, how to deal with it, and how you can tell if discontinuation symptoms are a return of depression or merely symptoms of discontinuing the drug.[xxxviii] They wrote that there is a “serious lapse in the system that ought to be providing complete information and clear warnings to patients and healthcare professionals about the extensive withdrawal effects of duloxetine.”[xxxix]
Eli Lilly warned doctors and patients that Cymbalta increased the risk for suicide but provided no clear warning for discontinuation syndrome. It told doctors that “patients experience withdrawal at a rate greater or equal to one percent,” even though its own studies showed a rate of over 50%.[xl] The FDA Safety Review of Cymbalta likewise downplayed Cymbalta discontinuation syndrome when it concluded, “It appears that symptoms are relatively mild and predictable for a significant minority of patients. Tapering duloxetine appears to be advisable for optimal patient comfort but not tapering does not appear to pose a serious risk.”[xli]
Cymbalta’s literature tells doctors to “decrease the dose slowly”[xlii] but does not tell them how.
It is hard for anyone to “taper off” Cymbalta because it comes as time-released capsules. You have to break apart the capsules, even though the manufacturer tells you not to, and divide up the tiny granules into smaller doses. It may take six to eight weeks of “tapering” to achieve discontinuation.[xliii]
Eli Lilly offers an 800-number for people in Cymbalta discontinuation syndromes but users of the service are reporting that their concerns are being brushed off or trivialized when they phone, leaving them more distressed. Lilly does not offer a help center or email system.[xliv] As a last resort, people withdrawing from Cymbalta have formed their own self-help communities on the Internet and are sharing information with one another.
How Can I Tell If I Need to Keep Taking Cymbalta?
Cymbalta is prescribed for major depressive disorder, which has a strict medical definition that is different from the way ordinary people define depression. Dr. Kirsch’s work and that of others indicates that people with major depressive disorders probably do have a chemical imbalance in their brains and can benefit from antidepressants like Cymbalta.[xlv] However, today most people obtain prescriptions for antidepressants from their family doctors without undergoing psychiatric evaluations from a mental health specialist, and they may not have major depressive disorders.[xlvi] Dr. Kirsch’s and other research indicates that Cymbalta and similar antidepressant drugs only work for the small minority of people with major depressive disorders, and not for a “case of the blues,” or the kind of depression that occurs after a major life event like losing your job, the death of a loved one, etc.[xlvii]
When you stop taking Cymbalta, you may experience difficult symptoms that mimic mental illness. Only a mental health specialist can evaluate whether you need to keep taking Cymbalta or whether you would be okay without drugs. The latest studies of “talk therapy” indicate that most people who are depressed benefit from a combination of both psychotherapy and drugs, and that psychotherapy can cause measurable biological changes in the brain that help cure the condition,[xlviii] yet most people on Cymbalta have never talked with a therapist.
Because it is so hard to tamper off from Cymbalta, you may want to consult an addiction specialist or phone any residential treatment center for help. Keep in mind that your “tapering off” schedule may take months, and that depending on individual factors such as how you have been taking Cymbalta, you may be unable to work or need hospitalization.
A minority of people are abusing Cymbalta by snorting it or taking large amounts at once. It is readily available without prescription through illegal Internet pharmacies. If this describes your behavior, it may be time to examine your drug abuse problems and enter a rehabilitation program.
Ask yourself the following questions. If you can answer yes to any of them, you may want to consult an addiction specialist about withdrawing from Cymbalta.
- Are you using Cymbalta without a prescription?
- Do you take Cymbalta as prescribed, or do you use it to cope with stress or other emotions?
- When you stop taking Cymbalta, do you experience severe withdrawal symptoms?
- Are the side effects of Cymbalta interfering with your everyday life and functioning at work or home?
- Have you tried unsuccessfully to stop taking Cymbalta?
- When you express concerns about Cymbalta, does your doctor ignore you?
- Have you been taking Cymbalta for over a year for depression or anxiety?
- Do you think you would benefit from “talk therapy”?
- Does Cymbalta seem to be working less for you now than when you first started taking it?
[i] Cymbalta Sales Data, May 2013, see http://www.drugs.com/stats/cymbalta
[ii]Duenwald, Mary. “How to Stop Anti-Depressant Medications,” The New York Times, May 25, 2004.
[iii] “Depression: Treatment and Drugs,” The Mayo Clinic, see http://www.mayoclinic.com/health/depression/DS00175/DSECTION=treatments-and-drugs
[iv] “Cymbalta,” Official Information from the United States Food and Drug Administration, Drugs.com, see http://www.drugs.com/mtm/cymbalta.html
[v] “Another Weapon Against Pain,” The Mayo Clinic, see http://www.mayoclinic.com/health/pain-medications/PN00044
[vi] Wilson, Duff. “Lilly Moves Closer to Approval to Market Cymbalta for Chronic Pain,” The New York Times, August 20, 2010.
[vii] “FDA Letter to Eli Lilly Regarding Cymbalta Advertising,” January 2010, see http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197257.pdf
[viii] Staton, Traci. “Lilly Takes the Lead in Ad Spending,” August 2012, see http://www.fiercepharma.com/story/lilly-takes-lead-dtc-ad-spending-surpassing-pfizer/2012-08-16
[ix] “Cymbalta,” Official Information from the United States Food and Drug Administration, Drugs.com, see http://www.drugs.com/mtm/cymbalta.html
[x] Josefberg H (2004-09-03). “Application number 21-733. Medical review(s).” (PDF). FDA. Retrieved 2009-04-14
[xi] Kirsch, Irving (MD). The Emperor’s New Drugs. New York: Basic Books, 2010.
[xii] “Cymbalta Medication Guide,” Ely Lilly Company, see http://pi.lilly.com/us/Cymbalta-Medguide.pdf
[xiv] “Cymbalta,” Official Information from the United States Food and Drug Administration, Drugs.com, see http://www.drugs.com/mtm/cymbalta.html
[xv] “Important Safety Information about Cymbalta,” Information from Eli Lilly, its manufacturer, see http://www.cymbalta.com/Pages/important-safety-information.aspx
[xvi] “Cymbalta,” Official Information from the United States Food and Drug Administration, Drugs.com, see http://www.drugs.com/mtm/cymbalta.html
[xvii] “Cymbalta Medication Guide,” Ely Lilly Company, see http://pi.lilly.com/us/Cymbalta-Medguide.pdf
[xviii] “Cymbalta,” Official Information from the United States Food and Drug Administration, Drugs.com, see http://www.drugs.com/mtm/cymbalta.html
[xxi] “Antidepressant, Heart Risk Association Needs Further Study,” Duke University News, February 22, 2010, see http://www.dukehealth.org/health_library/news/9535
[xxii] “Cymbalta,” Information from Eli Lilly, its manufacturer, see http://www.cymbalta.com
[xxiii] “Cymbalta,” Official Information from the United States Food and Drug Administration, Drugs.com, see http://www.drugs.com/mtm/cymbalta.html
[xxiv] “Cymbalta,” Information from Eli Lilly, its manufacturer, see http://www.cymbalta.com
[xxv] “Cymbalta,” Official Information from the United States Food and Drug Administration, Drugs.com, see http://www.drugs.com/mtm/cymbalta.html
[xxvi] “Management of Cymbalta overdose,” The RX List, see http://www.rxlist.com/cymbalta-drug/overdosage-contraindications.htm
[xxviii] “Serotonin Syndrome,” PubMed, the National Library of Medicine, see http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004531/
[xxix] “Quarterly Report, The Institute for Safe Medication Practices,” see sections on Cymbalta, http://www.ismp.org/QuarterWatch/pdfs/2012Q1.pdf
[xxx] Ibid, page 15.
[xxxi] Duenwald, Mary. “How to Stop Anti-Depressant Medications,” The New York Times, May 25, 2004.
[xxxii] Harris, Gardiner. “Student, 19, in Trial of New Antidepressant Commits Suicide,” The New York Times, February 12, 2004
[xxxiii] “Frequently Asked Questions about Cymbalta,” Eli Lilly, see http://www.cymbalta.com/Pages/frequently-asked-questions-about-cymbalta.aspx#al8
[xxxiv] “Eli Lilly and Company named in class action over deceptive and unlawful marketing of Cymbalta,” November 15, 2012, see http://gotaclassaction.com/eli-lilly-and-company-named-in-class-action-over-deceptive-and-unlawful-marketing-of-cymbalta/
[xxxv] Duenwald, Mary. “How to Stop Anti-Depressant Medications,” The New York Times, May 25, 2004.
[xxxvi] Ibid, and “Quarterly Report, The Institute for Safe Medication Practices,” see sections on Cymbalta, http://www.ismp.org/QuarterWatch/pdfs/2012Q1.pdf pg. 15.
[xxxvii] “Quarterly Report, The Institute for Safe Medication Practices,” see sections on Cymbalta, http://www.ismp.org/QuarterWatch/pdfs/2012Q1.pdf
[xxxviii] Ibid, pg. 13.
[xl] “Eli Lilly and Company named in class action over deceptive and unlawful marketing of Cymbalta,” November 15, 2012, see http://gotaclassaction.com/eli-lilly-and-company-named-in-class-action-over-deceptive-and-unlawful-marketing-of-cymbalta/
[xli] Andreason PJ. (2002) Clinical Review: NDA 21-247 Cymbalta (duloxetine). Silver Spring, MD: Center for Drug Evaluation and Research, Food and Drug Administration.
[xlii] “Frequently Asked Questions about Cymbalta,” Eli Lilly, see http://www.cymbalta.com/Pages/frequently-asked-questions-about-cymbalta.aspx#al8
[xliii] “Quarterly Report, The Institute for Safe Medication Practices,” see sections on Cymbalta, http://www.ismp.org/QuarterWatch/pdfs/2012Q1.pdf pg. 14
[xliv] “Cymbalta Discontinuation Syndrome,” The U.S. Food and Drug Administration, June 2009, see http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM172866.pdf
[xlv] Kirsch, Irving (MD). The Emperor’s New Drugs. New York: Basic Books, 2010.
[xlvi] Gilbert, Susan. “For Depression, Family Physician May Be First Choice, but Not the Best,” The New York Times, June 24, 2003.
[xlvii] “Cymbalta Discontinuation Syndrome,” The U.S. Food and Drug Administration, June 2009, see http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM172866.pdf
[xlviii] “The Benefits of Talk Therapy,” The New York Times, May 21, 2013.