Cymbalta Problems Reported For Withdrawal, Psychological Side Effects

An increasing number of patients are reporting problems with Cymbalta, including harsh withdrawal symptoms and psychological side effects when they try to stop taking the antidepressant, according to an analysis of adverse event reports submitted to the FDA. 

During the first quarter of 2012, at least 48 reports of Cymbalta withdrawal problems were received by the FDA, according to the latest edition of the Institute for Safe Medication Practices (ISMP) QuarterWatch report (PDF).

Reported side effects of Cymbalta included thoughts of suicide, anger, dizziness and paresthesia (unexplained itching, burning and tickling of the skin) when users tried to wean themselves off of the drug.

Early clinical studies have shown that about half of patients who abruptly discontinued use of Cymbalta suffered withdrawal symptoms, according to the ISMP report. About 10% of those cases involved severe problems and more than half of the cases involving side effects that lasted longer than a week or two.

The ISMP indicates that the FDA and the drug’s manufacturer, Eli Lilly, dropped the ball on providing adequate warnings for consumers and doctors about the withdrawal side effects of Cymbalta.

Cymbalta (duloxetine) was approved by the FDA in 2004 for the treatment of depression. It is part of a family of drugs known as selective serotonin reuptake inhibitors (SSRIs), which have been linked to symptoms of withdrawal since at least 2001.

Instead of providing clear information about the risk of serious and potentially severe withdrawal symptoms with Cymbalta, the medication guide and label provided with the drug only indicates:

“Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.”

ISMP called the warning “materially deficient,” pointing out that it does not tell patients what to be concerned about, how many patients could be affected, how severe the symptoms could be, and does not tell them the best way of quitting Cymbalta.

Eli Lilly told the ISMP that they referred patients to their doctors and pharmacists, but the independent group noted that the information given to doctors did not include withdrawal problems as something to discuss with their patients.

The report also raises issues regarding the long-term use of Cymbalta. Clinical trials only looked at the effects of six to nine weeks of use, but the ISMP points out that users may be on Cymbalta for more than two years, especially if they tried to quit, suffered withdrawal symptoms, and decided to stay on the medication.