What is Cymbalta? What does Cymbalta do?

Cymbalta is the brand name of Duloxetine, approved by the FDA to treat Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Diabetic Peripheral Neuropathic Pain, Fibromyalgia and Chronic Musculoskeletal Pain.

Cymbalta is sold in the United States by Lilly USA, LLC.

Does Cymbalta work?

Cymbalta has been reported to reduce some pain in some patients in studies of its effects on fibromyalgia patients, but the FDA found that Lilly exaggerated the degree to which Cymbalta actually helped patients by reducing their pain.

In 2010, the FDA sent Lilly a warning concerning their direct-to-consumer ads for Cymbalta, which targeted fibromyalgia patients and others suffering from chronic and intense pain. According to the FDA, the ads made unsupported claims of effectiveness and minimized or omitted required safety and side effects warnings.

In addition to obscuring or hiding the safety and side effects information, all of the ads in question made exaggerated claims of how well Cymbalta works and what it would do. The claim that Cymbalta reduced pain in more than half of patients omitted 35% of the study participants, who dropped out of the studies because they either experienced side effects or adverse events or Cymbalta did nothing for them at all. An accurate calculation of the total number of patients who found that they had reduced pain from the use of Cymbalta was actually slightly more than half of the remaining 65% of the patients, or about 33% of the patients in the study.

This number-juggling by Lilly was considered “misleading” by the FDA.

Sadly, Lilly’s marketing to physicians was also noted by the FDA to be misleading, so your doctor may not have received all necessary information. The FDA noted that Lilly sales representatives and marketing materials “do not adequately inform physicians about the likelihood and severity of discontinuation syndrome.” Additionally, the text used in the safety and warning sections of Cymbalta advertising material downplayed the severity of side effects in discontinuing Cymbalta, how long the withdrawal period might be, how much it could impact the patient’s life and the complexity of the process of tapering off Cymbalta.

The FDA panel also determined that the Lilly help system for Cymbalta patients was so ineffective as to be an “evasion of accountability.” That system consisted only of an 800 number, with staff that refused to disclose their names or the names of their supervisors. Although calls to the number were recorded, Lilly would not provide notes or transcripts taken during calls to the FDA inquiry.

What should I ask my doctor about before I decide to take Cymbalta for fibromyalgia pain?

In clinical studies, Cymbalta has only been shown to work for approximately one third of the patients taking it to reduce pain. And whether or not it works to reduce your pain, it has many side effects, including severe withdrawal symptoms. Trying it might be easy. Getting off of it might not.

Please don’t just stop taking Cymbalta on your own. You should always talk to your doctor before stopping any prescription medication, especially Cymbalta. Cymbalta can cause withdrawal symptoms, or “discontinuation syndrome.” Patients have reported extreme mood swings, physical and neurological problems, physical and psychological disturbances which affected their job function and family and social relationships. Additionally, they experienced a phenomenon called “brain zaps,” which some people have described as feeling like an electrical pulse in the brain.

Learn everything you can about Cymbalta before you start taking it.

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¹ Food and Drug Administration, “Highlights of Prescribing Information” (retrieved 14 August 2012),
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s039lbl.
²http://www.cymbalta.com/
³ Food and Drug Administration, Warning Letter (7 January 2010), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197257.pdf
⁴ Ibid.
⁵ Food and Drug Administration, “Cymbalta (Duloxetine) Discontinuation Syndrome,” (9 June 2009), http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM172866.pdf
⁶ Ibid.
⁷ Food and Drug Administration, “Cymbalta (Duloxetine) Discontinuation Syndrome,” (9 June 2009), http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM172866.pdf