Dozens of lawsuits accuse Eli Lilly & Co. of misleading consumers about the risk of withdrawal from stopping Cymbalta. At least 50% of people who stop Cymbalta experience withdrawal and 10% of cases are “severe,” but the label misleadingly states that the risk is “greater than or equal to 1%.”
Cymbalta and Withdrawal
Since at least 2001, experts have known that antidepressants like Cymbalta (duloxetine) may cause withdrawal. Severe withdrawal symptoms have been associated with many psychiatric medications, including antidepressants, benzodiazepines, amphetamines, and opioids.
Studies of Cymbalta Withdrawal
When Cymbalta was approved in 2004, the FDA required Eli Lilly & Co. to conduct clinical trials to investigate withdrawal symptoms. Researchers gave patients Cymbalta for 8-9 weeks, abruptly switched the patients to a placebo, and monitored them for another 2 weeks.
During the monitoring period, withdrawal occurred in 40-50% of patients, including 10% that were severe. Patients on higher doses (120-mg/day or more) reported more severe symptoms of withdrawal.
The study was published in January 2005 in the Journal of Affective Disorders. The most common side effects were dizziness (12.4%), nausea (5.9%), headache (5.3%), paresthesia that might include “brain zaps” (2.9%), vomiting (2.4%), irritability (2.4%), and nightmares (2.0%).
What is the problem?
These studies may not accurately reflect real-world statistics. Most people use Cymbalta for months or years, but the clinical trial lasted only two months. Lawsuits have been filed by people who were unable to stop taking Cymbalta because withdrawal symptoms were so debilitating when they tried to quit.
How Long Do Withdrawal Symptoms Last?
No one knows how long symptoms last. During clinical trials, about 54% of the patients with withdrawal did not recover after the 1-2 week monitoring period was over. Researchers did not follow up to see how long they persisted.
Warning Label for Cymbalta Withdrawal Symptoms
The warning label on Cymbalta says that withdrawal “occurred at a rate greater than or equal to 1%” — technically true, but 1% is significantly less than the 50% seen in clinical trials. Many lawsuits accuse Eli Lilly of misleading patients and doctors about the rate of withdrawal and completely omitting information about severe withdrawal.
The label on Cymbalta also warns:
“Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.”
This label does not describe how often “other symptoms” occur, how severe the symptoms may be, or what patients/doctors can do to reduce the risk. Instructions for how to gradually taper off the dosage are not included. In fact, the Prescribing Information warns against breaking, opening, or chewing the capsule — but opening the capsule is required to taper.
What is a “Brain Zap” from Cymbalta?
“Brain zaps” or “brain shocks” are described by patients as sudden, “electric-like” headaches that only occur for a few seconds and may occur repeatedly. Some people report that they feel like millions of tiny pinpricks, zapping, fizzing, or pounding in the head. They may be accompanied by dizziness. Some experts believe they are a form of paresthesia.
How Many People Have Been Injured?
According to the QuarterWatch (PDF) report for October 2012, there were 48 case reports of withdrawal during the first three months of the year. Because millions of people have taken Cymbalta, it is possible that thousands of people have developed withdrawal.
Symptoms of Withdrawal
Side effects of stopping Cymbalta “cold turkey” may include:
- Brain zaps
- Paresthesia (tingling, burning, itching, etc.)
- Psychiatric problems
- Suicidal ideation
- Personality changes
- Changes in appetite or weight gain
- And more