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Consumer Voluntary Reporting Form 

Rx psych drug side effects, injury, allergic reactions, and interactions are not rare. What is rare are patients and doctors who write to formally report their experiences, and problems with Rx drugs, and the prescribers who fail to properly warn their patients. 

DOWNLOAD DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

MEDWATCH Consumer Voluntary Reporting (FORM FDA 3500B) Scroll Down for more details. 

Form Letter:
Use to report side effects of Rx drugs  to your doctor

I was so injured by Rx psych drugs and doctors in denial that it took me months to prepare my written reports.
I'm sharing some tips to help a lot faster. These tips will help you if you are not having problems and especially if you are having problems reporting the drugs to prescribers in denial, and other uses.

Most people say, they would never had tried Rx psych drugs if they were properly warned, and or the doctor didn't deny the risks and reports of their patient's side effects. 

The drug's warning leaflets / legal disclaimer instruct to "report side effects to your doctor and the FDA. 

While this may now appear to help, most doctors are not documenting problems with Rx psych drugs. 

Write your report letter using a letter template you can edit to fit your situation, and be sure to include the best evidence provided, as reference. You don't have to print out the entire leaflets. All you need is the online reference, so we are collecting the evidence. 

Copy the letter and Mail to your doctor, pharmacy, authorities, and use in litigation as applicable. I am not aware of a current drug lawsuit be we are always interested to know the results and your insight. See more here. 

Download Report Form Letter

Download Cymbalta Duloxetine Warning Leaflet / Legal Disclaimer

Form Letter to Doctors / Nurse Practitioners and Authorities
(Edit to report your experiences and concerns)

We need to force a chain of formal written documentation. Records which will be saved and not lost, misunderstood, forgotten or ignored.
 

Make sure to use formal methods of communication when creating important reports and statements, especially when responding to government funded services and reports.
 

Step 4 of the 10 Step method is to order copies of your medical records. In some countries there may be a charge. Some doctor’s offices / surgeries may be obstructive. Please research your legal rights.

HOW TO WRITE A REPORT:
Select copy paste text and source URL links, and include in your reports.
Keep Copies and Mail by Certified Proof of Delivery to create legally binding documentation. 

 

Keep copies of your documentation, correctly dated, and use certified proof of posting and delivery to create legally binding documentation. This is regardless of any plans you may have but especially if you plan to sue, or report to any medical authorities. 

Use the evidence provided 
 

We suggest you use this format to give specialists all the appropriate information about you.
 

List the names and addresses of officials you wish to contact now and may wish to contact in the future:

- your doctor, nurse practitioner, local health authority, health board, FDA, NHS etc.

- List your own details: name, date of birth, home address

- Find and list the best sources of reference and evidence:

- the link to the drug's warnings leaflets
- as many links from drugs.com that you think are relevant
 

- Find and list the reasons you refuse to try or take any further psych drugs by category:

- antidepressants
- benzodiazepines
- anticonvulsants or any other drugs

Be as detailed as you possibly can.
 

Example: "Risks of all Rx psych drugs far outweigh the small, short-lasting benefits as claimed by the drug's leaflets / legal disclaimers and they require a slow taper for months and years."
 

- List the side effects and interactions you've experienced, (if any), as listed in your sources. Word-process everything and use Copy and Paste everything, so you can edit and then add to the information until you are completely happy with it. You will then have the same document to send to everyone.

-Keep copies of everything.
 

Ask for help if you need it. Drugs can give us brain fog. They can make us simply unable to act or function.
It's not you, you are not crazy. It's probably the adverse affects of Rx drugs.
Document everything. So make it official - start writing formally . Don’t just rely on telling

doctors or handing them a letter or a list.
 

Check that you have included absolutely everything mentioned in the detailed instructions. It's important to write to create documentation, regardless of any plans to sue. This is good professional practice - to use and require formal written methods of communication. You will have better results.
 

Drug manufacturers and government warning leaflets tell us to "REPORT ALL SIDE EFFECTS TO YOUR DOCTOR AND FDA". It is much more successful to detail everything in a digital document than just talk about it. Conversations are not recorded but letters and forms almost certainly have to be copied and filed.

FDA MEDWATCH
Consumer Voluntary Reporting
(FORM FDA 3500B) Cover page of 5 page report from.
Print form or Download from the government source:
FDA-3500B_Eng_Stat_Sec_Ext_11-10-2022.pdf

How to report problems with vaccines to the US Governement: 
https://vaers.hhs.gov/reportevent.html

Report to MedWatch 
 

Medwatch the reporting tool for drugs for the FDA. You might want to download and add to our files resources as this is the form that needs to be filled out to report harm to the FDA. It has specifics needed off of the prescription and for example if generic Duloxetine it will ask for manufacturer name.

I don’t know about the medical board. They are about licensing & not a reporting agency for drugs. Think of them as administrators of licensing.
https://medwatch.com/

FDA: What We Know about Marijuana 
Learn about the latest on marijuana legalization and the health effects and potential health benefits of cannabis. https://www.cdc.gov/marijuana/featured-topics/what-we-know-about-marijuana.html 

See More on our CBD page here: 

FDA 


DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration


MEDWATCH

Consumer Voluntary Reporting

(FORM FDA 3500B)

DOWNLOAD DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

MEDWATCH Consumer Voluntary Reporting (FORM FDA 3500B)

FDA MEDWATCH Consumer Voluntary Reporting (FORM FDA 3500B) 1 0f 5.png

DISCLAIMER: THIS IS NOT MEDICAL ADVICE! We do not employ doctors or licensed medical professionals, so we do not provide medical advice.
Nothing presented here is a substitute for the advice of a DOCTOR or other licensed health care provider.
Never stop, start or add medications or supplements to your health or mental health care regime without first checking for interactions or other problems, and thoroughly researching the substance. Before you employ any information here, consult your health care professional. No information here is the result of valid clinical trials.
Doctors and pharmacies are not obligated to warn. 
The responsibility to research prescription drugs lies solely on the consumer, or careprovider. 

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