We recently contacted a non-profit, public-interest organization called Public Citizen to discuss how we can further warnings on benzodiazepine drugs and Z Drugs. The reason we reached out to this organization is because they had a hand in getting the black box warning on fluoroquinolone antibiotics (FQs). The first petition to the FDA for the black box warnings (which is the FDA’s strongest warning) on FQs was denied, but the second one was approved because there was more compelling evidence for doing so. They also accomplished getting a “Dear Doctor” letter sent out warning about the dangers of FQs.

In speaking with Public Citizen, they also pointed us to an ovarian device called Essure which harmed a large number of women. Due to the organizing of these women, largely on social media, and their reports to the FDA’s Medwatch Program, the device received a black box warning. This case even prompted the FDA to go online and find 20,000 complaints from women who shared stories on Facebook and Twitter (which is where many BZ victims share their accounts of harm as well). To read more about the Essure case and the legislation that resulted from it, go here.

We informed Public Citizen that a 2010 petition to the FDA regarding benzodiazepines was denied. They encouraged us to re-petition but said that we can only do so with new compelling evidence that the benzodiazepine class of drugs is causing harm. Public Citizen pointed out that almost no one reports their adverse event to the FDA’s MedWatch Program, which is what the FDA uses to determine if they will act and put stricter warnings on drugs and that the place to start is to have all injured parties reporting their adverse events/injury. Once there is compelling evidence of harm (which will only happen if the people harmed come forward and report it), we can use that to re-petition the FDA for stronger warnings on benzodiazepine drugs. At that point, we will contact Public Citizen again in an attempt to garner their help and/or support with the re-petition efforts. Please note that benzodiazepines are on Public Citizen’s Worst Pills, Best Pills list as drugs to never take, so the organization is fully aware of their dangers.

For a more detailed explanation go here.

 

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 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)

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

  • Tolerance withdrawal

  • 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 challenging to taper from.  Smaller doses are needed.

DIRECT LINK TO FDA FORM: HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/MEDWATCH/INDEX.CFM?ACTION=REPORTING.HOME

 

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:

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

  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:

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. 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

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!

VIDEO WALKTHROUGH