REPORT YOUR ADVERSE DRUG REACTION

Anyone suffering from persistent benzodiazepine or Z-drug adverse drug reactions is encouraged to report them to the appropriate agency.

  • IF YOU RESIDE IN THE UNITED STATES, REPORT TO FDA’S MEDWATCH: (click below for detailed instructions)

Instructions for Reporting to the FDA

Please note the FDA’s Privacy and Confidentiality information in regards to the MedWatch Voluntary Report.

Who should 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 CT)
  • 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)

How to fill out the MedWatch Online Voluntary Reporting Form:

The form may be accessed at:

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

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
  6. Please provide as much detailed information as possible

Page 1

Click on Consumer/Patient 

2. About the problem 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

Tell us what happened and how it happened:

Include all relevant details such as:

  • Benzodiazepine drug you were taking and dose, please note if you took it as prescribed
  • How long you were on the drug
  • Method of discontinuation (long taper, rapid taper, cold turkey, detox)
  • Reason you were started on the drug
  • 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)
  • The length of time you have been experiencing symptoms
  • Any hospitalizations related to the drug or withdrawal process
  • Death related to the drug

Avoid emotional language and stick to the facts.

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

  • Brain MRI
  • Lumbar puncture
  • Electromyelogram/nerve conduction study
  • Formal cognitive testing
  • Cardiac testing
  • Chest X-ray or CT
  • Routine blood work
  • Anything else you had done that proves disability from the BZ drug or withdrawal

Please select the cause of the problem that applies below:

  • Check the first box (for a problem with a product)
  • Do you still have the product? Check yes or no

Page 3

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.

Page 4

Enter patient information.

Page 5

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

Page 6

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

 

In addition to agencies like the U.S. Food and Drug Administration and World Health Organization, PFS patients are encouraged to report their persistent side effects to RxISK.org, a global, independent pharmacovigilance organization whose database is used by patients, doctors and pharmacists to research prescription drugs and their side effects, ideally to identify problems early on in the life of a drug.