Change the Warning Labels: Why it Matters

The warning label for Cipro/ciprofloxacin is already 43 pages long. It includes warnings about devastating adverse effects including irreversible peripheral neuropathy, destruction of weight-bearing joints, prolongation of the QT interval, seizures, severe hepatotoxicity, Stevens-Johnson syndrome, “psychotic reactions (that) have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide,” and more. Most of the symptoms of fluoroquinolone toxicity are already listed on the warning label. But when patients go to their doctors with symptoms of fluoroquinolone toxicity, they are often told that their reaction couldn’t be from the Cipro, Levaquin, Floxin or Avelox they took. To say that it’s frustrating that many doctors aren’t aware of the side-effects that ARE LISTED ON THE WARNING LABELS, is an understatement. It is shameful that the adverse effects listed on the warning labels aren’t known and quickly acknowledged by all medical professionals. It’s bad enough that many of those practicing medicine don’t know how to help people heal from fluoroquinolone toxicity, the fact that the symptoms that are listed on the warning labels aren’t often acknowledged, is horrible.

What’s the Point of the Warning Label?

It begs the question, if adverse-effects that are listed on the warning label aren’t being acknowledged, what is the point of the warning label?

One could argue that the only purpose of the warning label is to protect the pharmaceutical companies from being sued. After all, if you are hurt by a drug in a way that is listed on the warning label, most lawyers won’t take your case, and suing the drug companies for damage done is difficult to impossible.

Since patients are rarely given complete warning labels with their prescriptions for fluoroquinolones, and because the lengthy warning labels are still inadequate, and because the Learned Intermediary Doctrine makes it so that there are no requirements that patients even be informed about the consequences of taking prescription drugs, one could certainly argue that drug warning labels don’t protect consumers at all.

Citizen’s Petitions for Changing Fluoroquinolone Warning Labels

There are two citizen’s petitions that have been filed with the FDA asking for additional warnings to be added to the warning labels for Levaquin/levofloxacin (that would likely carry over to the other fluoroquinolones too). One of the petitions is for adding additional warnings of psychiatric adverse events, and the other is for adding “Possible Mitochondrial Toxicity” to the warning labels.

Since the existing warning labels are so inadequate for actually warning doctors or patients, and are actually counterproductive for patients seeking justice for the harm done to them, many people have asked, “What’s the point in adding anything to the warning label?” and they have asserted that adding more warnings to the labels isn’t what we should be aiming for.

In many ways, I agree with their assertions. If warning labels aren’t adequate or heeded, and if they actually get in the way of justice, we should be fighting for something other than more additions to the warning labels. We should be fighting for severe restrictions of these drugs, as well as true informed consent where all possible adverse effects are gone over with patients prior to administration of fluoroquinolones, similar to the restrictions put on Warfarin and Coumadin. We should fight for awareness of fluoroquinolone toxicity, so that doctors know about the possible harm they can do to patients with these drugs, so they can avoid doing that harm. We should fight for more research into fluoroquinolones so that the damage done by them can be more fully understood. We should fight for cures and assistance for those who have been hurt by fluoroquinolones. We should fight for justice, and more.

Many people and organizations ARE fighting for these things. Media outreach efforts are raising awareness and the doctors who are reached by these media reports are using fluoroquinolones more prudently. For example, it was reported that prescriptions for Levaquin/Levofloxacin dropped significantly after “Local woman says popular antibiotic killed her husband” aired and was shared more than 135k times on social media. The Quinolone Vigilance Foundation (QVF) works with scientists researching fluoroquinolones. Many people have written letters to their Representatives, the FDA and the AMA asking that stronger restrictions be put on fluoroquinolones. Several law firms are suing Bayer and Johnson & Johnson on behalf of fluoroquinolone victims. These things are all moves in the right direction.

Throwing a Punch at the Drug Companies

Receiving a positive response from the FDA to the Citizens’ Petitions is also a move in the right direction. Adding psychiatric adverse events and mitochondrial toxicity to the warning labels is actually a huge weapon for floxie advocates. Warning labels themselves may be useless, but during the time when a warning label has things added to it, they can be a great tool, and a big gun we can use against the pharmaceutical companies. The ONLY times lawyers are willing to take cases to sue the drug companies are when warning labels change. For example, when the fluoroquinolone warning labels were adjusted in August, 2013 to note that permanent peripheral neuropathy is a possible effect of fluoroquinolones, several law firms took cases of those who are suffering from peripheral neuropathy after taking fluoroquinolones. Before the warning label changed, they wouldn’t take the cases, because, appallingly, you can’t sue drug companies for hurting you, you can only sue them for “failure to warn” of the harm they’ll do. It’s a really stupid situation and stupid system. BUT, the time when warning labels change is the brief period of time in which you can sue the drug companies for “failure to warn” and it’s the brief period of time when we have the chance to fight the pharmaceutical companies. Opening this window is a good thing, and I support the Citizen’s Petitions because they are wonderful “window openers.” I hope that the FDA responds positively to them, and adds both psychiatric adverse events and “Possible Mitochondrial Toxicity” to the warning labels for all fluoroquinolones.

If the window for justice can be opened by the Citizen’s Petitions, we may be able to throw a big punch that actually hurts Bayer and/or J&J. If psychiatric adverse events are added to the warning labels, ANYONE who has suffered from a psychiatric illness who had previously taken Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin or Floxin/ofloxacin can sue the drug companies that produce fluoroquinolones. That’s a lot of people who can, potentially, take a chunk of change out of Bayer’s and J&J’s pockets.

Mitochondrial toxicity is linked to many diseases, including all autoimmune diseases, neurodegenerative diseases, fibromyalgia, autism, CFS/ME, cancer, psychiatric illness, obesity, etc. Adding mitochondrial toxicity to fluoroquinolone warning labels opens the possibility for a HUGE punch to the pharmaceutical companies. If it is fully acknowledged that fluoroquinolones cause mitochondrial toxicity, anyone who comes down with a disease that is linked to mitochondrial toxicity can sue the manufacturer of the drug that hurt them. If everyone who got sick with a chronic disease who had previously taken a fluoroquinolone was able to sue Bayer or J&J, the drug companies would take note, and change may even occur.

It will be difficult for the FDA to claim that “possible mitochondrial toxicity” shouldn’t be added to fluoroquinolone warning labels. After all, it is stated IN THEIR DOCUMENT entitled, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure,” that:

“Ciprofloxacin has been found to affect mammalian topoisomerase II, especially in mitochondria. In vitro studies in drug-treated mammalian cells found that nalidixic acid and ciprofloxacin cause a loss of motichondrial DNA (mtDNA), resulting in a decrease of mitochondrial respiration and an arrest in cell growth. Further analysis found protein-linked double-stranded DNA breaks in the mtDNA from ciprofloxacin-treated cells, suggesting that ciprofloxacin was targeting topoisomerase II activity in the mitochondria.”

THEY acknowledge that fluoroquinolones deleteriously affect mitochondrial DNA. The least they could do is put that information on the warning labels.

Movement…. Hopefully in the Right Direction

I obviously have a lot of conflicting feelings about changing the fluoroquinolone warning labels. I wish that we, as citizens who have been hurt by these drugs, had more opportunities for enacting change. I also wish that the warning labels were meaningful documents that were heeded by doctors and patients alike, and that they didn’t primarily serve the pharmaceutical companies. I also wish that more victims of fluoroquinolones were able to gain justice BECAUSE THEY WERE WRONGLY HURT BY A PRESCRIPTION DRUG, rather than making them jump through legal loop-holes about “failure to warn.” Until those things change though, we need to use the tools and opportunities we have. If enacted, the Citizen’s Petitions give us an opportunity to throw a big punch.

I hope that the FDA changes the warning labels to reflect what is known about fluoroquinolones causing mitochondrial toxicity and psychiatric adverse events.  If the warning labels change, and the punch behind the mitochondrial toxicity and psychiatric adverse events is big enough, maybe real change will occur. We can hope.