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Let's Flood The Fda


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#1 LindaVandy

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Posted 16 April 2013 - 09:11 AM

I've done some research over the last 12 hours and read a lot of interesting material. Someone on this forum should take a whack at wikipedia info on SSRI Discontinuation Syndrome as well as the page re: Cymbalta. 

 

Anyhow, you can send a complaint to the FDA with this lengthy form either online or printout:

https://www.accessda...atch-online.htm

http://www.fda.gov/d...s/UCM082725.pdf

or this little one: http://www.accessdat...der/comment.cfm

 

Now to find a printer that works.....


#2 lady2882Nancy

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Posted 16 April 2013 - 11:50 AM

That is a good idea. If more people did this it would as least get them to take another look at what is really happening.


#3 LindaVandy

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Posted 17 April 2013 - 01:24 PM

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!

 

 

Dear Linda,

 

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.

 

Best Regards,

 

L.E.

Drug Information Specialist | Division of Drug Information Center for Drug Evaluation and Research | Food and Drug Administration

 

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter @FDA_Drug_Info

 

CDER has made it easier for small business to interact with the Agency via Small Business Assistance available by email at CDERSmallBusiness@fda.hhs.gov, by phone at 1-866-405-5367 or (301) 796-6707, or on the web at http://www.fda.gov/smallbusinessdrugs. Download the Small Business widget for your website at http://www.fda.gov/Drugs/ucm153379.htm

 

Take the CDER Small Business survey at https://www.surveymo...ersmallbusiness.

 

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.

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#4 LindaVandy

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Posted 17 April 2013 - 01:28 PM

That medwatch form is way to complicated and obtuse for my fractured brain, can we find someone to help us?


#5 lady2882Nancy

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Posted 17 April 2013 - 04:41 PM

I would say that we need to get some help with this unless we wait until we are further along in recovery to be able to fill out the forms needed.

 

Anyone have any ideas of how we could get these forms submitted?

 

I think if enough people reported the severity and how long the symptoms last that they would at least notify prescribers and pharmacists as to the problem with discontinuing. The information (even the updated info) is still too vague and I have not seen any updated warnings on med inserts for the patient other than the standard.

"Do not stop Cymbalta or change your dose without talking to your healthcare provider, as you could have side effects."

Somehow "you could have side effects" just doesn't cut it with me.


#6 fishinghat

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Posted 17 April 2013 - 05:11 PM

I am sure that someone has posted this already BUT here is the statement that is sent out with each package of cymbalta to be upplied to the patients. (my prescriptions did have this info attached).

 

 

 

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.

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 maybe considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate [see Dosage

and Administration (2.4)].


#7 Kirksd55

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Posted 17 April 2013 - 05:41 PM

I just wanted to say I hope hitting that checkmark is a good thing I tried it on one of my responses and it said I couldn't vote for myself so I'm thinking that it means you like the article or the post. I'll try to research that but if anybody can help (most likely Nancy) ha ha will be able to tell me just what it means. 😳

#8 lady2882Nancy

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Posted 17 April 2013 - 05:52 PM

Do you mean the little check mark on the right? I see a little bluish box on the right with a check in it and it says Like This in it but there isn't one in my own postings.

Is this the one that you mean?

If it is that is yes that is how you show you like a posting.

 

LOL of course I am in and out of here all day.


#9 lady2882Nancy

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Posted 17 April 2013 - 05:56 PM

fishinghat - none of the pills I got had that info in them.

All they had was the general "Do not stop Cymbalta or change your dose without talking to your healthcare provider, as you could have side effects."

Sucks to be me lol


#10 Kirksd55

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Posted 17 April 2013 - 06:05 PM

Yeah on the same page with you Nancy thanks.

#11 fishinghat

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Posted 17 April 2013 - 06:08 PM

Lady2882Nancy, I don't know the Canadian rules but here in the states one of those full medication profiles will be placed in the bag with your medicine UNLESS you sign a release stating you don't want one.


#12 lady2882Nancy

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Posted 17 April 2013 - 06:38 PM

fishinghat

Here there is a big difference between the prescribing info and the patient info, but it is advised to contact your pharmacy for more information concerning any med. Here in Saskatchewan, the pharmacist is allowed to advise on how you should take your meds, on how to discontinue meds and is allowed to give you a temporary refill if you run out of refills on an existing Rx. There are even meds that they can dispense as needed. That varies by province (I guess that would be states for you US peeps).

 

kirksd55

I would need to figure out how to post my pic upside down or between upside down and sideways at an angle might be better lol


#13 Kirksd55

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Posted 17 April 2013 - 06:41 PM

I think this is a good idea too. I was just thinking the other day "I wish there was a way to get the word out". when I see the commercial on crapbalta. I think that I would like to see a warning about it after it. Like a link to this forum !


#14 lady2882Nancy

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Posted 17 April 2013 - 06:45 PM

When I see the commercial I have to resist the extremely strong urge to smash the TV.


#15 Kirksd55

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Posted 17 April 2013 - 07:11 PM

Yeah I heard that good thing I don't have a gun !

#16 Kirksd55

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Posted 17 April 2013 - 07:16 PM

After trying to fix my picture with my really really sick computer I found another picture On my iPhone to put up I think it best represents how I will be feeling sooner or later. Now after all the frustration I have been through the past few minutes I built up the anxiety worse than it already was time for the Klonopin !!😖

#17 praying

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Posted 22 April 2013 - 03:32 PM

Thank you, Linda, for the suggestion and the FDA weblink. I just submitted my complaint regarding Cymbalta withdrawal syndrome (7 weeks of nausea and diarrhea, ever decreasing energy & motivation, increasing depression, hopelessness, helplessness, tearfulness, sobbing).  After 4 weeks my psychiatrist said i should be through Cymbalta withdrawal and the nausea and diarrhea were probably due to the prozac I'd started to taper off Cymbalta, so he had me stop that as well.  I've fallen down a dark rabbit hole the past week.  After reading fellow Cymbalta withdrawal sufferers comments, I started Prozac just now again.  I called my doctor last night saying I couldn't go on another 2 weeks, per our plan, like this and his office called and made me an appointment for Thursday -- four days away!  I was just going to stay in bed and try to sleep my life/this pain away, but a friend emailed me that I need to take action, so I went on this website and am so glad I did.  I had heard discontinuation could go on for 2 or 3 months, but when my psychiatrist said what he did, I trusted him.  Bless you all.  May be all be at peace, may we all be healthy, may we all be happy.


#18 lady2882Nancy

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Posted 22 April 2013 - 03:37 PM

Hello praying and welcome

Don't worry about still having side effects from discontinuing, lots of us do. I'm really hoping that I will improve by the 6 week point but it could continue to 12 weeks as well, which is what the newest info on withdrawals say.

The Prozac should help alot.

Let us know how you are doing.

Take care of you

Nancy


#19 Kirksd55

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Posted 22 April 2013 - 03:58 PM

I'm a little confused and I can't think straight. What Link should I go for this class action suit Or to file a complaint about Cymbalta ?

#20 LindaVandy

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Posted 25 April 2013 - 06:54 AM

File a complaint with the FDA for now, I've yet to find a viable class action suit (CAS), perhaps someone has to die first..... has you or a loved one suffered or died as a result of crapalta use..... Can't wait to hear that commercial! of course, i have no TV

 

Come on everyone, let the fda know we are REAL!

 

 

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


#21 lady2882Nancy

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Posted 25 April 2013 - 09:47 AM

For those of us in Canada we can report adverse reactions here:

http://www.hc-sc.gc....n/index-eng.php

 

Reporting by Consumers

There are links for

printing out the form and mailing

reporting online

 

Since this is Canada and things have to be reported in a certain way then I advise reading

Adverse Reaction Reporting Information





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