The U.S. Food and Drug Administration prepared a presentation about Cymbalta “discontinuation syndrome,” popularly called withdrawl, as early as 2009.

Cymbalta is an antidepressant, a drug designed to help patients suffering from depression. However, concerns have grown that patients who stop taking the drug may experience a constellation of Cymbalta withdrawal symptoms.

The FDA’s presentation shows that at the time most of the evidence for serious Cymbalta withdrawal was anecdotal. However, subsequent research studies have indicated that Cymbalta withdrawal is more common than Eli Lilly, the drug’s manufacturer, indicated, and may be a very serious problem for many people at the end of their course of treatment.

The presentation included a number of serious complications reported from Cymbalta withdrawal. Patients who stopped taking Cymbalta described symptoms such as paranoia, mood swings, irritability, and other psychiatric problems. Additionally, many patients reported “brain zaps,” a disorienting sensation of shocks in the brain that come without warning. Some of the anecdotes collected by the FDA indicated that patients nearly went to jail over behavioral symptoms from Cymbalta withdrawal, and that many patients’ relationships with their physicians had become strained due to Cymbalta withdrawal symptoms neither was aware of.

The FDA also stated that the situation surrounding Cymbalta withdrawal can impact doctor-patient relationships. The agency stated that Cymbalta’s drug safety inserts did not describe the complexity or severity of the syndrome, and that the situation unfairly places the burden of explaining the situation on the physician. Since many physicians were unaware of Cymbalta withdrawal complications, the FDA states that that “the Doctor/patient relationship is wrecked,” according to many reports. Additionally, the situation could promote a distrust of doctors, antidepressants, or cause doctors or patients to refuse to see each other due to distrust. One of the slides in the FDA’s presentation concludes that “this is a process flaw – there is no excuse for it” [emphasis in original].

The FDA’s presentation indicates that Eli Lilly’s drug design and how the company deals with users exacerbates the situation. First, the drug maker does not provide smaller doses to help patients taper off. Instead, patients have to crack open tablets and count out drug beads from the capsule. Alternatively, patients may have to seek out compounding pharmacy services out-of-pocket, for the duration of tapering, which could take months.

Additionally, Eli Lilly’s website does not provide an email complaint line for Cymbalta problems. Instead, patients are required to call a help line, with no electronic paper trail. The FDA alleges that the help line staff were “minimizing” the Cymbalta withdrawal symptoms, which could further distress a patient suffering from Cymbalta withdrawal. Additionally, call center workers would not provide their name or that of their supervisors, which the FDA characterized as an “evasion of accountability.”

Dozens of Cymbalta withdrawal lawsuits have been filed by patients suffering from Cymbalta withdrawal symptoms. These lawsuits allege that Eli Lilly did not do enough to warn and protect the public from the risks allegedly associated with its drug. These lawsuits typically seek to recoup medical costs, lost wages, and other expenses allegedly related to Cymbalta withdrawal.