I got my reply, it was so helpful and informative, they are sticking to the story only 1% of us are crazy and that this small percentage does not constitute a problem, though I may be reading too much into this..... BTW FDA, I don't have a twitter account!
Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.
I am very sorry to learn about the withdrawal symptoms you have experienced with Cymbalta, and the impact that this has had on your quality of life. As you know, some patients reported withdrawal symptoms association with discontinuation of Cymbalta. The prescribing information (also known as the product labeling or package insert) is the most complete source of information about an FDA approved drug product.
The prescribing information discusses discontinuation of Cymbalta under "Warnings and Precautions" and states,
"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. Patients should be monitored for these symptoms when discontinuing treatment with Cymbalta. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate."
You may find additional information on possible adverse events in the product labeling at: http://www.accessdat...s040s041lbl.pdf (see page 7, section 5.7 Warnings and Precautions for discontinuation information).
We can take regulatory actions that improve the safety of products like Cymbalta by assessing voluntary reports from patients, submitted to MedWatch. We carefully evaluate and analyze all reports that are available to us and make recommendations for possible actions if the science-based risk evaluation warrants the actions. Possible actions that the FDA can take include: requiring the drug’s manufacturer to conduct additional studies, requiring changes in the drug’s FDA-prescribing information, requiring a REMS (Risk Evaluation and Mitigation Strategy) for the drug, sending letters to health professionals advising them of new potential risks, and in rare cases, removing a drug from the market. Please express your desire for a lower dose of Cymbalta to be marketed in your MedWatch report. I have also shared your email with the Review Division to ensure they are aware of your desire for a lower dose of Cymbalta to be marketed for discontinuation.
You can report the serious adverse effects of Cymbalta that you have experienced to the FDA through the MedWatch reporting program. It is a voluntary system of reporting to FDA any adverse events and/or product problems such as the ones you have experienced. You may submit your voluntary report via the following methods.
You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/S...tch/default.htm), clicking on "Reporting Serious Problems to FDA", then "Reporting by Consumers". In the "Resources for You" box on the left you can choose to:
1. Complete the voluntary form 3500 online at: https://www.accessda...atch-online.htm.
2. Download a copy of the form and either fax it to us at 1-800-FDA-0178 or mail it back using the postage-paid addressed form. Form available at: http://www.fda.gov/d...s/ucm082725.pdf, instructions at: http://www.fda.gov/S...s/ucm149236.htm.
You will be personally contacted by an FDA staff member only if we need additional information. With the volume of reports on all issues, the Center does not have the resources to provide direct feedback to each reporter, or to confirm whether a report was received for a particular individual/incident, or the status or outcome of a report.
We rely on our website to offer new safety information on drugs as a means to convey the results of investigations from MedWatch reports. Information about emerging safety signals and issues related to drug packaging are posted on the CDER Internet page at http://www.fda.gov/D...s/ucm111085.htm.
It is important to note that the FDA’s role is to determine whether the benefits of a drug outweigh its possible risks for the United States population as a whole. Not every drug is appropriate for every situation and only you and your health care provider can decide if the potential benefits of Cymbalta outweigh its potential risks for you. Consequently, many products that are FDA-approved have associated risks, but remain on the market because of their potential to bring benefit to many patients. I encourage you to continue working with your physician or other healthcare provider to ensure your discontinuation is using a gradual reduction, as recommended in the prescribing information. As noted above, if intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Please talk with your doctor about what you are experiencing. I wish you all the best and I thank you again for taking the time to write to us.
Drug Information Specialist | Division of Drug Information Center for Drug Evaluation and Research | Food and Drug Administration
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This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.