Change the Warning Labels: Why it Matters

Change the Fluoroquinolone 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.

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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.

 

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4 thoughts on “Change the Warning Labels: Why it Matters

  1. Linda Livingston September 10, 2015 at 10:32 am Reply

    Another great piece. I sadly agree with “One could argue that the only purpose of the warning label is to protect the pharmaceutical companies from being sued.”
    Regarding the learned intermediary doctrine, as I understand it, I do not think it means “there are no requirements that patients even be informed about the consequences of taking prescription drugs” altogether, but rather shifts the burden. The learned intermediary doctrine has basically let the pharmaceutical manufacturers (and the prescribing pharmacies) off the hook, placing the onus on the physician to warn. Recently, that has been changing in the courts, as far as pharmacies that dispense the drugs.
    And I could not agree more with “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…” I also agree re more research, most especially so we can learn how to UNDO the damage that has been done.
    I am not sure I am as hopeful as you are regarding attorneys taking cases more often when warnings are added, because no matter how many warnings are listed, it is still difficult to prove causation, which is what the doctor/pharmacy/ manufacturer will argue. It’s absurd of course, that you would have a slew of side effects occur while taking or just after finishing one of these drugs, but they will always want to say it wasn’t caused by the drug (and I think this is especially true of psychiatric disorders.) I have now contacted dozens of attorneys (for medical malpractice and against the pharmacy) and my case is a bit different because I also was given prednisone at the same time–and the problems I see are twofold: first, in the state of CA “pain and suffering” is limited to $250,000 so most attorneys won’t take it unless you had a lucrative job that you can no longer do, so they can also figure in lost earnings. Second, and this relates to the above, is the problem of having ANY other physician that you have seen corroborate that the cause of all your problems was the FLQ. That is why I still believe that rather than more warnings, these drugs need to be either removed or at the very least restricted to only last line of defense (which they initially were, until the manufacturers realized how much money they could make off of them.) This would also have the same effect as far as enlisting an attorney, I believe, because they could point to the fact that they are being restricted because they are so dangerous.
    Finally, as you, I hope the FDA will takes steps in the right direction, but I again do not hold out great hope, since they have known for decades about the deleterious effects of the FLQs and still allow them to be used for simple infections, and because the FDA is riddled with big pharma people. The new commissioner had most of his salary, while at Duke University, underwritten by Merck, Novo Nortis, etc.

  2. Debs September 10, 2015 at 4:25 pm Reply

    In my opinion, they will not stop …. period, they are right now developing more sinister ways of administering them, also hybrids etc, & we also have many more, some much more potent FQs in clinical trials as we speak. Unfortunately there is a longer term agenda here , which the FQs are a very useful part of, triggering symptoms which cause & can be mistaken for conditions where the drugs they want people on for life can be prescribed which taken long enough will cause ADRs resulting in the desired outcome .

    True FULL informed consent on ANY drug let alone FQs, is just NOT possible as the raw data on ADRs, what actually happened in those clinical trials, is ONLY known to Big Pharma.

    The FDA IS Big Pharma.

    They have no intention of taking them off the market & imo, will NOT take them off the market unless they are forced in some way to develop something else to replace them

    Even if we ARE successful with these new black box warnings , do you really think they are also going to add these black box warnings to the ear & eye drops ? seeing they do not even yet admit they are damaging people … I think not.

    Perhaps I am just tired & rather cynical , but I have seen a lot change in respect to recent development of these drugs, as our voice is getting louder, & personally, I do not now think just adding more black box warnings to the FQs is the answer here. I believe they should be legally restricted to literally last line of defence, there should be something to sign when prescribed in respect to consent, & they should be forced in some way to develop something else to replace them, & THEN they should be removed from the market entirely.

    • Linda Livingston September 10, 2015 at 5:52 pm Reply

      My jaded self is in total agreement with your jaded self. I believe the ONLY way this will resolve on the side of consumers is if big pharma and the FDA (and yes they are grossly intertwined) are brought to justice in the legal system. Again, I urge everyone to write to Attorney General Loretta Lynch, write the White House, write members of congress. Just today the DOJ announced it will hold more individuals accountable for white collar crime, as opposed to just the corporations themselves. On the face this is more in response to wall street and the banks, but it would be welcome in the area of big pharma. Big tobacco ended up in court and took a beating, although they are finding new ways to peddle their poisons—but if it could happen to big tobacco, it could happen to big pharma. There have been a slew of FLQ reports lately on network affiliates, but the people who NEED to have this information are probably not seeing them. That is why I again urge you to WRITE! Let them know side effects are horrendous and may be permanent. Let them know side effects are NOT rare, according to a freedom of information request. Write!

  3. […] taken off the market once they are approved. Rather than removing dangerous drugs from the market, the FDA prefers to simply increase the size of drug warning labels (which doesn’t actually make drugs any […]

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