Dr. Bennet and SONAR Submits New Citizen Petition Regarding FQAD

Dr. Bennett and Southern Network For Adverse Reactions (SONAR) have submitted another Citizen Petition to the FDA requesting the following:Dr Bennett

(1) Add Fluoroquinolone-Associated Disability (FQAD) to the Levaquin Black Box Warning

It is requested that the following language regarding FQAD be added to the current Black Box Warning on the Levaquin label:

Fluoroquinolones, including LEVAQUIN®, have been associated with disabling and potentially irreversible serious adverse events, including a constellation of disabling symptoms known as Fluoroquinolone-Associated Disability (FQAD) which may result in a substantial disruption of a person’s ability to conduct normal life functions; which may be permanent; and which may affect multiple body systems, including musculoskeletal, neuropsychiatric, peripheral nervous system, vision, hearing, skin, and cardiovascular.

(2) Add Psychiatric Adverse Events to the Levaquin Black Box Warning

It is requested that the following language regarding Psychiatric Adverse Events be added to the current Black Box Warning on the Levaquin label:

Fluoroquinolones, including LEVAQUIN®, have been associated with disabling and potentially irreversible serious adverse events, including psychiatric adverse reactions, which include suicide and suicide-related adverse effects.

(3) Require a Risk Evaluation and Mitigation strategy (REMS) for Levaquin

 

You can read the petition here.

Share

Admin

...damaged by fluoroquinolones in 2007 at age 46. Prior to, a healthy law enforcement official. Now an amateur FQ researcher, author, and blogger.

7 Responses

  1. Diane Willams says:

    My health and life have been ruined by Levaquin. Floxed in 2015, and it gets worse every day.

  2. Cc says:

    I don’t nderstand why this position paper does not state all Fluoroquinolone antibiotics. In addition, Levaquin is not being manufactured in its brand name form any longer, would you know why?

    • Jackie Bragdon says:

      I agree 100%, Cc! All FQ black box warnings should have the same info. I believe the patent ran out on Levaquin, combined with class action lawsuits, were the prompt for taking it off the market. It is still available in generic form. Cipro and Levaquin turned my life upside down

    • Admin says:

      There are many reasons (legal, science, etc…) why the researchers target specific pharmaceuticals as opposed to the entire class. It is hard enough to get a black box warning for a single drug let alone an entire class. One of the main reasons is research. They have to back up everything they claim to the FDA for each drug. Many of the FQ researchers have limited or shoestring budgets and do not have the fund to focus on the task of taking on the entire class of pharmaceuticals. The FDA will then scrutinize the petition to the extreme. The researchers have to play by strict rules and regulations set forth by the FDA. I don’t defend the process, just try to explain it. The warning, if enacted will apply to the generic as well.

  3. Darlene says:

    I think their guard will be down since the Levaquin is not in production. Therefore it will be easier to pull this off. Then the rest will have to follow. One step at a time. This will be a foot in the door.

  4. Dr. Gorski says:

    Thank you Dr. Bennett. As an esteemed colleague I admire your tenacity to stand up and advocate for these drugs.

Leave a Reply

Your email address will not be published. Required fields are marked *

WordPress Anti Spam by WP-SpamShield