There has always been concern about discontinuing antidepressants and withdrawal symptoms. But a new analysis finds that anywhere from 44 percent to 50 percent of Cymbalta patients experienced withdrawal symptoms after clinical trials, and more than half were resolved within two weeks. Moreover, there was a “serious breakdown” at both the FDA and Eli Lilly in providing adequate warnings and instructions. The analysis was conducted after the Institute for Safe Medicine Practices, after reviewing adverse events reported to in the first quarter of 2012 and found 48 case reports of drug withdrawal for Cymbalta. These included blackouts, suicidal thoughts, tremor, and nausea, and several cases involved hospitalization. This contrasted with an FDA safety review conducted in 2001 for the Cymbalta new drug application.
“It appears that symptoms are relatively mild and reliably predictable for a significant minority of patients. Tapering duloxetine at discontinuation appears to be advisable for optimal patient comfort, but not tapering does not appear to pose any serious risk,” the FDA wrote, according to ISMP, which cites the 2001 document [here is the ISMP report]. Meanwhile, Lilly studied withdrawal effects in nine early clinical trials for depression. “As the trials reached the end of the treatment at eight or nine weeks, patients were switched to an inactive placebo and then monitored for an additional one or two weeks. Patients who volunteered new symptoms or more severe symptoms were counted as experiencing withdrawal effects,” ISMP writes in its analysis.
Lilly, subsequently, reported symptoms in 44 percent of patients who discontinuing Cymbalta after nine weeks or less, and 50 percent in longer trials. “About 10 percent of withdrawal symptoms in short-term trials were rated as severe and nearly 54 percent had not resolved after up to two weeks. What happened to these patients after two weeks is unknown. The outcomes of severe and persistent cases remain poorly studied,” ISMP writes…
The upshot: ISMP concludes by writing that “a major lapse has occurred in the FDA-approved information for patients about the risks of stopping duloxetine. The information for prescribing physicians is somewhat better, but still inadequate about counseling patients; instructions for an adequate taper regime are omitted entirely. Furthermore, a major gap exists in our scientific understanding of the incidence and management of withdrawal syndrome cases that are severe and persistent.”
I’ve got a few cases where people are finding they cannot go off Cymbalta at all. It’s in the same league as Pristiq and Effexor for withdrawal problems.
Some people are going through hell going off these drugs, when is medicine going to recognize this?
Alto,
Thanks for responding. I hoped you would. Any advice about how the reduce doses with this encapsulated medication? I hadn’t realized that the half-life of Cymbalta is short, like Paxil and Effexor, like 5-7 hours!
Also, Thanks for the Healy Link!.
A couple more links: David Healy’s RxISK.org has a story up about a strange but not uncommon Cymbalta withdrawal symptom: gruesome nightmares:
http://wp.rxisk.org/night-of-the-living-cymbalta-bs-story/
And at http://www.cymbaltawithdrawal.com you can find a large community of sufferers trying to puzzle this out for themselves. I would say at least half of them were put on Cymbalta for back pain, fibromyalgia pain, arthritis pain … something other than depression.
Two more links: David Healy’s RxISK site has a story up on a weird but all too common Cymbalta withdrawal syndrome
http://wp.rxisk.org/night-of-the-living-cymbalta-bs-story/
And at this discussion board a lot of Cymbalta survivors are trying to piece together the answers themselves:
http://www.cymbaltawithdrawal.com
Most who have been there advise taking at LEAST a month to withdraw. Trouble is, Eli Lilly has made it hard, putting out only 60 mg and 30 mg capsules (60 mg being the standard dose). You have to pull the capsule open and shake out the little beads a dozen or so at a time, and hope for the best …
Mickey, apologies, I just saw this!
To taper, people are opening the Cymbalta capsules and counting out beads, like they do with Effexor XR.
Do this at a rate that minimizes withdrawal symptoms. “Micro-tapering” seems to work well: Reduce by one bead at a time, per day or per week, depending on the individual’s tolerance. Hold on micro-taper if withdrawal symptoms appear, restart only when symptoms go away completely.