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Altostrata

Report your withdrawal symptoms to the US FDA and other government agencies

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Altostrata

The US Food and Drug Administration gathers aftermarket reports of adverse drug reactions from consumers. (Under the Obama administration, this reporting system was recently improved.)

 

To report your adverse reactions and withdrawal symptoms, complete the FDA MedWatch Online Voluntary Reporting Form (3500) online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or by phone 1-800-332-1088

 

(Citizens of countries other than the US may also report to the FDA's MedWatch system.)

 

In the US, you can also file a complaint about your doctor with your state medical board.

 

Here are links to the state medical boards:

http://www.ama-assn.org/ama/pub/education-careers/becoming-physician/medical-licensure/state-medical-boards.page

Edited by Altostrata
updated information

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Altostrata

Recently, the FDA sent out a warning to doctors not to prescribe Celexa at dosages greater than 40mg because higher dosages cause potentially dangerous disruption of heart rhythm. (By the way, all antidepressants prolong the cardiac QT interval.)

 

http://psychcentral.com/news/2011/08/24/celexa-linked-to-heart-damage-when-taken-at-high-doses/28914.html

 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm

 

The FDA issued this warning because of post-marketing reports. This indicates someone is reading some of these reports.

 

File a post-marketing report with the FDA here.

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Altostrata

Go to https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm to enter an adverse event report in the FDA database or

phone 1-800-332-1088

 

(Citizens of countries other than the US may also report to the FDA's MedWatch system.)

 

Now, the FDA has been collecting these adverse reports for many years, but has been crippled by no system to analyze the information in its database.

 

A private company, AdverseEvents.com, has been formed to create and sell reports based on the data in the FDA adverse events database. They say they update them real-time, meaning directly from the FDA database.

 

Some basic statistics are available free from this company. Go to http://www.adverseevents.com/ and click on the Patients button to get access to this information.

 

For example, if you search on "paxil" and click on "drug withdrawal syndrome," ( http://www.adverseevents.com/drugevent.php?AEDrugID=681&reac=Drug+Withdrawal+Syndrome ), you'll find

 

adverseevents.com_paxilwithdrawal.png

Report your withdrawal problems to the FDA here. Eventually, this will end up in AdverseEvents.com reports, we will be able to retrieve it, and it will add to our ammunition to get medicine to recognize the severity of this problem.

Edited by Altostrata
updated information

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Altostrata

It's true the FDA has been incompetent to do the data mining itself. As ever, it's working on systems http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm274442.htm

 

Conceivably, a patient or patient groups could commission a special report from AdverseEvents.com. But the data has to be in the FDA's Adverse Events database first!!!!!!

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Barbarannamated

How to circumvent the FDA altogether? Or, is there any method to collect data retrospectively (retroactively?) from the massive numbers of events that were never reported and just medicated or attributed to the original 'disease state/disorder'? The magnitude is incomprehensible. To me.

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Altostrata

David Healy has raised money for another adverse events system, http://Rxisk.org

 

Like AdverseEvents.com, one of its sources is the FDA Adverse Events Reporting System (AERS) database.

 

Report your adverse event with psychiatric drugs to the FDA now

-- it will end up in a report Dr. Healy can use to limit the use of these drugs.

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Altostrata

The UK's National Institute for Health and Clinical Excellence (NICE) publishes practice guidelines for National Health Service doctors in the UK. See NICE antidepressant discontinuation guidelines for UK doctors

 

UK residents, you may wish tell NICE of your experience with your doctor and point out gaps in these guidelines -- write nice@nice.org.uk

 

and submit a Yellow Card adverse event report here http://yellowcard.mhra.gov.uk/

Edited by Altostrata
updated information

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meistersinger

Recently, the FDA sent out a warning to doctors not to prescribe Celexa at dosages greater than 40mg because higher dosages cause potentially dangerous disruption of heart rhythm. (By the way, all antidepressants prolong the cardiac QT interval.)

 

http://psychcentral.com/news/2011/08/24/celexa-linked-to-heart-damage-when-taken-at-high-doses/28914.html

 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm

 

The FDA issued this warning because of post-marketing reports. This indicates someone is reading some of these reports.

 

File a post-marketing report with the FDA here.

 

However, I saw another advisory recently that the Qt interval while on Celexa is now not as serious as first thought. Any takers on this?

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Altostrata

Bumping to remind all to report adverse drug reactions to the FDA!

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Skyler

David Healy has raised money for another adverse events system, http://Rxisk.org

 

Like AdverseEvents.com, one of its sources is the FDA Adverse Events Reporting System (AERS) database.

 

Report your adverse event with psychiatric drugs to the FDA now

-- it will end up in a report Dr. Healy can use to limit the use of these drugs.

 

Alto.. is plain old withdrawal considered an adverse event?

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Altostrata

Yes, "plain old" withdrawal is an adverse event!!!!

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alexjuice

I wish I knew precisely what to attribute to what.

 

Once I figured I'd taken 20 or so medications over 14 years. By year 2, I was never on just one medication at any one time, except right now (if one concedes a benzo is a benzo is a benzo).

 

I'm pretty sure it was my SSRI which induced alcohol cravings, but I was never drinking alcohol and taking just an antidepressant.

 

The only adverse reaction I can ascribe to any med with certainty is a minor one. In 1998 I trialed Paxil. I quickly developed a skin rash on my chest and Dr. removed the Pacil for Celexa.

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starlitegirlx

I just tried filling out the form and as it is structured with certain boxes you have to check, it is difficult to find ones that are suitable for withdrawal from ADs.

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Altostrata

Dr. Healy has started a withdrawal syndrome survey to gather data for Rxisk.org, go to http://RxISK.org/SoS and enter your information.

 

(If anything seems confusing, send the Rxisk folks a note, they want to know how well this is working.)

 

Our discussion of Rxisk.org is here http://survivingantidepressants.org/index.php?/topic/2866-david-healys-rxiskorg-wants-withdrawal-stories/

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Carrie215

I understand community members and moderators have written threads about the importance of submitting adverse event reports to the FDA and I want to let you all know about a mobile app that’s been developed to make the reporting process much easier, called MedWatcher (http://www.medwatcher.org). 

 

We have simplified the FDA report form into four quick steps that typically take about 5-10 minutes to complete. When users submit a report via MedWatcher, we format the information and send it to the FDA. We then de-identify and publish the report on MedWatcher so that other users can read about these experiences — somewhat like a “consumer reports” page for medical products. We've combined both data from reports that have been submitted to us directly and data from FDA’s published adverse event reports in order to provide as much adverse event information as possible for each drug.

 

The FDA hasn’t published any adverse event reports since its last quarterly report, which came out at the end of 2012, and MedWatcher hasn’t received many reports for antidepressants since it went “live” last summer. This means that there is very little formally-documented adverse event data for antidepressants from the past year that is currently available to the public.


We are trying to encourage people to report their side effects and withdrawal symptoms using the MedWatcher app or website instead of directly to the FDA for this very reason. We share each report with other users as soon as we can format it, instead of just waiting for a summary of reports every few months from the FDA. In the interest of drug transparency and raising awareness for the problems that antidepressants cause, I really believe if we can document everyone’s withdrawal symptoms, we could make some serious changes. MedWatcher is fundamentally driven by the public health mission of making drugs, devices, and vaccines safer and we don’t get any money for each additional report that is submitted.

I’m won’t be posting much in the forum but I am happy to answer any questions anyone might have about the MedWatcher reporting process.

 

Thanks very much!

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btdt

How is this any different than the Med watch of years ago and what happened to all the reports about antidepressants that were already there...???

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Carrie215

Hi btdt,

 

Thanks for your questions. MedWatcher is different from MedWatch:

1. MedWatcher is run by Epidemico, not by the FDA. We're a small public health analytics team with different products that enable the sharing of public health information and promote patient safety. We are collaborating with the FDA on this project to help them improve the existing AE reporting process and increase drug transparency.

2. MedWatcher is a mobile app, enabling people to submit AEs on their mobile phone at the time they experience them, wherever they are

3. the data from MedWatch is published on a quarterly basis, in bulk reports; MedWatcher publishes reports to its page in real-time (essentially as soon as we can format them)

 

The antidepressant reports that have been submitted directly to the FDA through its MedWatch system are not missing, they just aren't made public on a regular basis nor in a user-friendly way. The quarterly reports that FDA puts are out are large files in formats (XML) that are pretty cumbersome to navigate if you don't have the right software (which many people don't). If you go to our MedWatcher reports page (

 

Hope that answers your questions!

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Altostrata

Those FDA Medwatch reports are analyzed to some extent by Rxisk.org http://rxisk.org

and AdverseEvents.com http://www.adverseevents.com/

 

Rxisk.org is also collecting reports to be relayed to the FDA database.

 

The FDA's own ability to analyze adverse event reports is an embarrassment. Because virtually nothing comes of adverse events reported to the FDA, U.S. doctors don't take making these reports seriously.

 

Carrie, while we truly appreciate your company's interest in adverse events -- something that's certainly missing in psychiatry, to the detriment of patient health -- it seems to me that DOCTORS should using your app, rather than patients.

 

An individual patient would rarely use the app, needing to report an adverse event only once (even though it might last for years, as antidepressant withdrawal syndrome sometimes does) while, in the best of all worlds, a doctor would use the app daily to report an adverse event every time he or she sees a patient suffering from one.

 

Perhaps your company could facilitate doctors reporting adverse events to the FDA more frequently. (I say this knowing that most doctors are incapable of recognizing adverse events, but if reporting were taken more seriously, they might pay more attention.)

 

Or is your app intended to collect ongoing symptoms from patients over time?

 

What happens when you sign up on medwatcher.org?

 

(By the way, medwatcher.org is optimized for phone or tablet -- I find it difficult to navigate on a computer.)

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Carrie215

An individual patient would rarely use the app, needing to report an adverse event only once (even though it might last for years, as antidepressant withdrawal syndrome sometimes does) while, in the best of all worlds, a doctor would use the app daily to report an adverse event every time he or she sees a patient suffering from one.

 

Perhaps your company could facilitate doctors reporting adverse events to the FDA more frequently. (I say this knowing that most doctors are incapable of recognizing adverse events, but if reporting were taken more seriously, they might pay more attention.)

That is a really great point, Altostrata. We are still learning about who might use the app the most, and I agree with you that it could be a useful tool for physicians. There are plenty of healthcare professionals that use our app to report now, but not nearly enough as there could be. I think too they might take it more seriously if it were easy to report, rather than it just being another long form to fill out -- which is where our app could come in. We do want the tool to be one that empowers patients, though. They are the ones that best know their own bodies and how they are feeling, and they might experience quite a few, non serious side effects that might not warrant a doctor's visit but could be reported using their own phone.

 

I'll pass along your feedback to our developers. We're in the midst of improving the usability of the desktop version of the app, so hopefully whatever issues you're experiencing on the computer will improve. If you have any specific complaints, that would be helpful too.

 

When you sign up on Medwatcher, you can create a profile by adding products to a Watch List. This triggers a News Feed and you'll receive notifications (if you elect to do so) when there is news, a reported adverse event, or an FDA update related to that product. We are still discussing the addition of other features such as a journal that could track side effects over time -- which, I agree, would be useful to patient users!

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btdt

Using a phone to report as a patient identifies the patient to whom?  With the Snowdon issues of late and patients fear of the system some are afraid... I could see this being an issue.  Doctors have always had access to the the FDA if they wanted to report a drug and since it all goes to the FDA in the end ... who you say yourself did nothing with all the other reports they have why bother.... I don't see a huge upside of this and a real risk to privacy ... as in who is going to be mining your site and taking names.  

Go ahead call my paranoid but I could see how pharma would be interested in this information. Anything done thru a cell phone is identifiable trackable ect. 

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Altostrata

Phone the FDA 1-800-332-1088 and press #4 to speak to a representative and make a complaint.

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Muddles

Thanks alto - is FDA only based in America?

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Altostrata

The FDA is an agency of the US government. However, its database is referred to by other countries.

 

You can also post a report on Rxisk.org, David Healy's site based in the UK, to add to the FDA database.

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Tilly

Dr. Healy has started a withdrawal syndrome survey to gather data for Rxisk.org, go to http://RxISK.org/SoS and enter your information.

 

(If anything seems confusing, send the Rxisk folks a note, they want to know how well this is working.)

 

Our discussion of Rxisk.org is here http://survivingantidepressants.org/index.php?/topic/2866-david-healys-rxiskorg-wants-withdrawal-stories/

Done

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purcy51

Just tried the adverseevents.com link. Seems it is now a company,Advera Health, that helps pharmaceuticals mitigate adverse event reporting. "Spinning" the information so it doesn't looks so bad. Just my impression, I could be wrong.

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samanthaelizabeth
On 6/3/2012 at 4:45 PM, Altostrata said:

David Healy has raised money for another adverse events system, http://Rxisk.org

 

Like AdverseEvents.com, one of its sources is the FDA Adverse Events Reporting System (AERS) database.

 

Report your adverse event with psychiatric drugs to the FDA now

-- it will end up in a report Dr. Healy can use to limit the use of these drugs.

I just shared my story with RXrisk.org

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YammySteph
On 10/16/2011 at 5:32 PM, Altostrata said:

Recently, the FDA sent out a warning to doctors not to prescribe Celexa at dosages greater than 40mg because higher dosages cause potentially dangerous disruption of heart rhythm. (By the way, all antidepressants prolong the cardiac QT interval.)

 

http://psychcentral.com/news/2011/08/24/celexa-linked-to-heart-damage-when-taken-at-high-doses/28914.html

 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm

 

The FDA issued this warning because of post-marketing reports. This indicates someone is reading some of these reports.

 

File a post-marketing report with the FDA here.

This was written in 2011. I was on Celexa 60mg in 2016...

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