FDA REPORTING PROGRAM

REPORTING HARM OUTSIDE OF THE USA?

For all other countries, download the World Health Organization’s Collaborating Centre for International Drug Monitoring list of pharmacovigilance agencies (be sure to scroll down to the world map at the bottom of the page).

WHO ARE WE ASKING TO REPORT TO THE FDA’S MEDWATCH PROGRAM?

  • Injured patients (the ones who took benzodiazepines as prescribed) who are located in the United States
  • Family members (if the patient taking the benzodiazepine died – e.g., from suicide or abrupt cessation)
  • Your doctor who is aware of your BZ adverse event/injury (you will have to ask them to do it on your behalf, as most don’t self-report even though they are supposed to)

Things to focus on in the reporting (if you had them):

  • Tolerance withdrawal
  • Akathisia
  • Protracted withdrawal
  • Suicidal ideation
  • Psychosis
  • Rage/Violent thoughts/Behaviors
  • Nerve pain or other physical manifestations of harm
  • Cognitive and mental manifestations of harm
  • Any documentable harm (e.g., some people have brain scans showing injury, etc).
  • Dosage you were on (the FDA incorrectly believes certain dosing is safe) and time period (as we can indicate that the dependence/withdrawal/injury occurs quickly in some.
  • That the dosages the benzodiazepines currently come in are too challenging to taper from. Smaller doses are needed.
  • Antibiotic interactions/antibiotic induced withdrawal (ie: fluoroquinolones). Should make a report on both prescriptions, if relevant.

PLEASE FORWARD YOUR EMAIL CONFIRMATION TO FDA@BENZOINFO.COM SO WE MAY TRACK THE NUMBER OF SUBMISSIONS.

HOW TO FILL OUT THE MEDWATCH ONLINE VOLUNTARY REPORTING FORM:

The form may be accessed at:

FDA Report

Important points:

  1. This form is relatively easy to fill out and self explanatory but detailed instructions are provided below
  2. There are 4 pages that need to be filled out online (page 1,3,4,5). Please push “next” after completing a page to move on to the next one (located at bottom of page)
  3. Page 6 is to review your information and edit if needed. If everything looks good, click on “submit” and you are done!
  4. Please report on benzodiazepines or Z-drugs only
  5. Items with a red star by them are required, the rest are optional
  6. Please provide as much detailed information as possible
  7. Confidentiality: FDA recognizes that confidentiality is an important concern in the context of adverse event reporting. The patient’s identity is held in strict confidence by FDA and protected to the fullest extent of the law. However, to allow for timely follow-up in serious cases, the reporter’s identity may be shared with the manufacturer unless specifically requested otherwise. The FDA will not disclose the reporter’s identity in response to a request from the public, pursuant to the Freedom of Information Act.

1. Click on Consumer/Patient

2. About the problem

What kind of problem was it?
check the first box (were hurt or had a bad side effect)

Did any of the following happen?

Check all that apply including hospitalization, disability or health problem, life-threatening, and/or death

Date of occurrence Use approximate date you first noted problems related to your medication

3. Tell us what happened and how it happened.

It can be helpful to write this out separately, and copy and paste it into the complaint. You may wish to save that file for the future. Remember there is a 4000 character limit.

Include all relevant details such as:

  1. Benzodiazepine drug you were taking and dose, please note if you took it as prescribed
  2. How long you were on the drug
  3. Method of discontinuation (long taper, rapid taper, cold turkey, detox)
  4. Reason you were started on the drug
  5. List all symptoms you noticed while taking or discontinuing the drug (make sure to include severe symptoms such as suicidal ideation, attempted suicide, seizures, profound disability, bedridden, etc)
  6. The length of time you have been experiencing symptoms
  7. Any hospitalizations related to the drug or withdrawal process
  8. Death related to the drug
  9. Please avoid emotional language. Just the facts please.
  10. Please focus on benzodiazepines, not other medications.

4. List any relevant tests or laboratory data (include normal results to show that symptoms were not due to some other process), examples include:

  1. Brain MRI
  2. Lumbar puncture
  3. Electromyelogram/nerve conduction study
  4. Formal cognitive testing
  5. Cardiac testing
  6. Chest X-ray or CT
  7. Routine blood work
  8. Anything else you had done that proves disability from the BZ drug or withdrawal

5. Additional Info

Check the first box (for a problem with a product)
Do you still have the product? Check yes or no
This page has been filled in for example purposes only. Please provide your own answers.
Click the blue question mark if you need more detail about the question.
Lot number can be obtained from your pharmacy but is not necessary. NDC number is on your prescription label. You do not need to enter these numbers if currently off the medication (unless you still have a prescription bottle).
If not currently on benzos, enter the maximum dose you were on previously.
If you took more than one benzo, click on add another product.
Enter patient information

Add reporter (your) information. Check the yellow box at the bottom if you do not want your identity disclosed to the manufacturer.

Review and edit your information. Press submit when you are done.

Forward your confirmation email to fda@benzoinfo.com so we know how many have filed a complaint!