Cymbalta Discontinuation Syndrome / Symptoms Include "Brain Zaps", Extreme Mood Swings (anger, irritability), And Neurological Or Physical Problems
(Posted by Tom Lamb at DrugInjuryWatch.com)
While generally thought of as an antidepressant drug, Cymbalta (duloxetine) from Eli Lilly and Company has been approved by the FDA for use by patients diagnosed with:
Major Depressive Disorder;
Generalized Anxiety Disorder;
Diabetic Peripheral Neuropathic Pain;
Fibromyalgia; and,
Chronic Musculoskeletal Pain
Based on prescriptions for these several medical conditions and others — by means of so-called "off-label" prescribing — Cymbalta became a blockbuster drug for Lilly after being approved by the FDA in 2004. The first generic versions of Cymbalta were approved by the FDA on December 11, 2013.
The Prescribing Information, or drug label, for Cymbalta (duloxetine) (accessed 10/27/14) indicates that stopping this drug is no more problematic than other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors). From this section of the label, 5.7 Discontinuation of Treatment with Cymbalta:
Discontinuation symptoms have been systematically evaluated in patients taking duloxetine. Following abrupt or tapered discontinuation in placebo-controlled clinical trials, the following symptoms occurred at 1% or greater and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue.
During marketing of other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. Although these events are generally self-limiting, some have been reported to be severe.
But then there are allegations made by patients and their advocates that the effects of Cymbalta withdrawal can be severe, and extend for weeks or even months. According to this item found on the FDA's website, "Cymbalta (Duloxetine) Discontinuation Syndrome — Issues of Scope, Severity, Duration & Management", these conditions include:
• Extreme mood swings (anger, irritability)
• Debilitating “Brain Zaps”
• Physical and neurological problems
And, as regards these negative withdrawal "side effects" which patients have allegedly suffered when they stopped taking the antidepressant Cymbalta, there are claims of possible misconduct by Eli Lilly set forth in that same item:
1) Cymbalta discontinuation syndrome is more severe and much more widespread than acknowledged by Eli-Lilly
2) Lilly sales representatives and marketing materials do not adequately inform physicians about the likelihood and severity of discontinuation syndrome
3) Lilly Direct-to-Consumer (DTC) advertizing [sic] is misleading related to the probability, severity and complexity of Cymbalta discontinuation
4) Lilly has not developed and fielded a clinically proven protocol for safely discontinuing Cymbalta
Significantly, in a report published by the Institute for Safe Medical Practices (ISMP) in the October 2012 of edition of QuarterWatch we find apparent support for some of those claims. From a preview in the front of this QuarterWatch publication concerning that "Duloxetine (CYMBALTA) and Serious Withdrawal Symptoms" report by ISMP:
We investigated a signal for duloxetine (CYMBALTA) and serious withdrawal symptoms. In the first quarter of 2012, 48 case reports of withdrawal described an array of problems that included neurological effects such as paresthesia and dizziness, psychiatric problems such as crying, suicidal ideation, and anger, and other symptoms including effects on appetite and weight gain. Early clinical studies of abrupt discontinuation showed that withdrawal effects occurred in 40 to 50% of patients, that 10% of those were severe, and that approximately half had not resolved when side effects monitoring ended after one or two weeks….
In the full report we document a serious lapse in the system that ought to be providing complete information and clear warnings for patients and health professionals about the extensive withdrawal effects of the antidepressant duloxetine. The Medication Guide for patients gives no hint that withdrawal symptoms can affect half of those discontinuing duloxetine, and that many cases may be severe, persistent, or both. The prescribing information for physicians and pharmacists does not provide realistic schedules for dose tapering or a clear picture of the likely incidence of these reactions….
As a result of this situation, lawsuits have been filed against Eli Lilly by some patients alleging Cymbalta caused withdrawal reactions and injuries when they discontinued or attempted to stop using Cymbalta. These drug injury lawsuits also claim that Lilly failed to adequately warn doctors and patients about the withdrawal risks associated with Cymbalta.
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