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Fluoroquinolone Associated Disability (FQAD) and the FDA

November 6, 2015

It is disturbing to me that the FDA’s Antimicrobial Drug Advisory Commitee is focusing FQAD on people who were healthy prior to the exposure to FQs and and received it for a “minor” infection … They are basically saying that if you were “already sick” you don’t have FQAD. Their criteria:

  • Patients who were previously healthy
  • Patients who took a fluoroquinolone to treat a urinary tract infections, bronchitis, or sinusitis
  • Patients who experiences adverse events in two or more body systems, including peripheral neuropathy, neuropsychiatric, musculoskeletal, senses, cardiovascular, and skin.
  • Patients who had a substantial disruption of their normal life functions.

Unfortunately, the first two criteria don’t preclude having the last two criteria. In my spouse’s (Joe M Johnson) case, his diabetes was well controlled and he was not experiencing symptoms such as PN. The instant the massive dose of Cipro hit his system via IV he began to experience pain. He told his nurse, his doctor and the associated people floating in and out of his hospital room that he was in severe total body pain. They told him that “cellulitis hurts” even though the cellulitis was located in his lower left leg ONLY. Then they upped his morphine. Since that fateful day in 2009, he has had a cascade of symptoms including PN tendon tightening over his entire body, exacerbated cardiovascular problems, exacerbated diabetes problems, skin problems, and neuropsychiatric problems that essentially peaked within three months of his exposure and have not gone away. The pain syndrome he experiences daily has not abated in any way and most likely has not peaked. There has been, indeed a “substantial disruption” of his normal life… going from a man who in the course of his job walked 2-4 miles a day, operated heavy machinery, welded, cut metal with hand shears, to name but a few of the physically taxing activities of his daily work.

Today, he mostly sits with his legs raised, waiting for the next time he can medically take another pain pill. I’d say his normal life was substantially disrupted.

For the FDA to suggest that only people who were previously healthy prior to their exposure to this poison could possibly be affected by adverse events and thus have FQAD is outright mendacity.

His daughter, nephew and father also all had immediate reactions to these drugs, but because of Joe’s experience, they stopped taking them and got better. The fact that they all had a reaction to the drug seems to indicate a genetic component to the sensitivity and predisposition to damage.

These drugs need to be removed from the market immediately and new testing started with the REAL groups the drugs are used to treat… MOST people are not “completely healthy” and have some kind of underlying health issue that these drugs have an ability to “switch on” … their ability to work at the genetic level is a large part, I believe, of the damage potential. The manufacturers and the FDA have absolutely NO IDEA how a drug that operates on a genetic level works in someone with a genetic anomaly that might predispose the individual to the potential array of adverse reactions these drugs can cause.

References:

News Report of the meeting

Federal Register Announcement of the Committee Meeting

November 2015

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