Cymbalta® Warning Label

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Does the Cymbalta Warning Label Warn of Withdrawal Risks?

The Cymbalta warning label, during much of the time it has been on the market, states:

Discontinuation symptoms have been systematically evaluated in patients taking duloxetine [Cymbalta]. Following abrupt or tapered discontinuation in placebo-controlled clinical trials, the following symptoms occurred at rate greater than or equal to 1% and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo: dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis, and vertigo.

Although the language has changed slightly over the years, the warning about discontinuation has remained the same.

The Cymbalta warning label is misleading. The phrase “greater than or equal to 1%” suggests to patients and their doctors that the risk is low. While both 2% and 99% are greater than 1%, a drug that has a 2% withdrawal risk is very different than a drug with a 99% risk.


In fact, according to Cymbalta manufacturer Eli Lilly and Company’s own research, at least 44% to 50% of patients who stop taking Cymbalta experience withdrawal. And, over 25% experience moderate or severe symptoms—some even requiring hospitalization. These numbers are based on an analysis of six short term (8-9 weeks) trials and three longer term (34-52 weeks) trials. The article documenting these withdrawal risks can be found here.

The risk rates set forth in Lilly’s analysis are only the tip of the iceberg. The manner in which Lilly evaluated withdrawal in these studies of Cymbalta would not have captured all of the patients experiencing withdrawal. In fact, based on Cymbalta’s comparatively short half-life, the withdrawal rate is more likely to be in the range of 66% to 78%.

A 2009 Google search of “Cymbalta” and “withdrawal” supports this conclusion—the search resulted in nearly 1.5 million hits. See slide 4 of Cymbalta Discontinuation Syndrome PowerPoint presented to the FDA in 2009.

What does all this mean? We believe that the Cymbalta warning label which states that the risk of withdrawal is greater than or equal to 1% is grossly misleading.

Before stopping any medication you must first consult with your healtcare provider.