The prominent consumer group Public Citizen indicates that the antidepressant Cymbalta should not be taken for any of the approved uses, as there no evidence that the benefits outweigh the risk of serious and potentially life-threatening side effects associated with the medication.
In the June 2012 issue of the group’s Worst Pills, Best Pills Newsletter, Public Citizen classified Cymbalta as a “Do Not Use” medication.
While the group previously concluded that Cymbalta should not be used for major depressive disorder (MDD), it now indicates that it should not be used for treatment of any form of depression, as well as all other uses for which it has been approved by the FDA, such as generalized anxiety or any form of pain, including fibromyalgia.
Cymbalta (duloxetine) was introduced by Eli Lilly in 2004, and has grown to become a widely used antidepressant. In 2010, more than 14.5 million prescriptions for Cymbalta were written, generating sales in excess of $2.6 billion.
Public Citizen indicates that the success of the medication can not attributed to any solid evidence that Cymbalta is better than other antidepressants, but rather was caused by agressive marketing strategies by the drug maker.
Side effects of Cymbalta have been linked to a number of serious adverse events, including a risk of suicide, suicidal thoughts, dangerous drug interactions, increased risk of bleeding, liver failure and serotonin syndrome, which is a potentially life-threatening condition that may cause changes in mental status, motor abnormalities, cardiovascular changes and gastrointestinal problems.
In 2004, the FDA forced the manufacturers of Cymbalta and other antidepressants to add a “black box” warning about the increased risk of suicidal thoughts or tendencies associated with use of the medication, which is the strongest warning that can be placed on a prescription medication.
In their report, Public Citizen raises questions about the effectiveness of Cymbalta and other medications used to treat depression, pointing to research that has found the differences in behavior between individuals using antidepressants and those taking placebos to be minimal or nonexistent.
“Research is beginning to reveal that there may be effective alternatives to antidepressant drugs,” wrote Public Citizen in the newsletter, pointing to studies that have concluded that exercise training and other activities may be equally effective as medication in reducing depression.
Public Citizen has recommended that their readers not use Cymbalta, but indicates that no medication should be discontinued without consulting the prescribing physician. The group recommends gradual discontinuation of Cymbalta under medical supervision, and urges users to seek immediate medical treatment if they experience symptoms of Cymbalta side effects, such as liver toxicity, serotonin syndrome or neuroleptic malignant syndrome (NMS).