Florical drug information

I take Florical and do not notice any negative effects from it. I do notice that when I run out and don’t take it for a while, my tinnitis gets worse. Then when I start taking it again the tinnitis quiets down again. Dr Lippy of Warren Ohio did my stepedectomy in 1999. He did a wonderful job which improved my hearing significantly. Since then I’ve lost some hearing in that ear but it is still much better than it was. I’m now losing hearing in my other ear and may someday need surgery in that ear too. As a patient I would highly recommend Dr Lippy and his practice.

Regarding long-term effects of flouride, the national academy of sciences (NAS) has a report from 2006 which gives a comprehensive interpretation of the scientific literature. The NAS was tasked by the EPA with doing the review to evaluate safety of flouride supplementation of drinking water.


http://www.fluoridealert.org/health/epa/nrc/index.html

The report costs $50-$80 (on-line versus print).

For adults concerned about taking flouride supplements (like me), the report is inconclusive. Here is a summary as I understand it.

My recommended dose is about 10mg flouride (3 florical tablets) daily. The report recommends that the daily dose in water should not exceed about 1-2mg/liter (giving a typical person a maximum flouride dose of 2-3mg daily). Above 4mg/liter the report warns of adverse health consequences (summarized below).

The adverse health consequences discussed are mostly for developing kids or for people exposed to 4mg/L or more for decades. Most people considering flouride supplements are not in this category. So the report is not conclusive regarding supplements. Still, after reading the report, I am pretty sure I don’t want to take 10mg flouride per day for an extended period. A year makes me a little nervous.

The kinds of problems discussed in the report are:

  • bones, muscles, teeth
  • reproduction and development
  • neurotoxicity (brain) and behavior
  • endocrine (hormones)

The studies cited by the report are only suggestive, not conclusive. Existing studies done on humans are only epidemiological (studying population data, not doing experiments), and these seem to focus on children. The remaining studies are mainly on rats. These studies seem to show clear biological effects on bones and brains (and perhaps other organs, I didn’t read the full report) at daily dosages less than the rat-equivalent of 10mg. Whether these effects cause health problems is unclear.

Furthermore, the risks seem complicated. For example, some of the problems show up only if low levels of aluminum are also in the diet, and the level of aluminum matters – higher levels, or very low levels, lower the risk.

My summary conclusion is that there are probably some risks of taking 10mg/day flouride, although the degree of risk is not clear.

(continued from previous post)

On the other hand, I’ve been able to find a few studies (via pubmed) that suggest that flouride supplements can help slow down hearing loss.

note: 25 mg of sodium flouride = 11.3 mg of flouride (actually, florine)

  • [Otospongiosis and sodium fluoride. A clinical double-blind, placebo-controlled study on sodium fluoride treatment in otospongiosis.](http://www.ncbi.nlm.nih.gov/pubmed/2655462)
  • Am J Otol. 1989 Jan;10(1):20-2.Links

    (positive results on ~ 20 mg flouride/day)

    “The effect of sodium fluoride treatment in patients with otospongiosis has been evaluated in a prospective clinical double-blind, placebo-controlled study of 95 patients. The results showed a statistically significant greater deterioration of hearing loss in the placebo group than in the group actively treated with 40 mg of sodium fluoride daily. These results support the view that sodium fluoride can change otospongiotic, active lesions to more dense, inactive otosclerotic lesions.”

  • [Fluoride Therapy for Cochlear Otosclerosis? An Audiometric and Computerized Tomography Evaluation.](http://scholar.google.com/scholar?hl=en&lr=&cluster=2615447961535151138)
  • Acta Otolaryngol 2001; 121: 174 – 177

    (positive results on ~ 11mg flouride/day; 1-2 years suffice; sample size ~ 20)

    “The progress of sensorineural hearing loss (SNHL) in patients with cochlear otosclerosis was compared for 19 patients treated with fluoride for 1-5 years and 22 untreated controls. CT scans of eight patients before and after fluoride treatment were evaluated visually. Fluoride therapy arrested the progression of SNHL in the low (250, 500 and 1,000 Hz) (p<0.001) and high (2 and 4 kHz) (p=0.008) frequencies. It seemed to be more effective for the higher frequencies in cases with an initial SNHL of <50 dB. Fluoride administration for 4 years did not seem to be superior to a shorter treatment period (1-2 years). For six patients followed up after discontinuing fluoride therapy there was minimal deterioration in SNHL. There was no clear relationship between the size and site of otospongiotic lesions on CT and the severity of SNHL. Follow-up with CT evaluation did not provide reliable information as to the efficacy of fluoride therapy.”

  • [Sodium fluoride: effectiveness of treatment for cochlear otosclerosis.](http://scholar.google.com/scholar?hl=en&lr=&cluster=9915185532078141485)
  • Am J Otol. 1986 Mar;7(2):121-5.

    (positive results on ???/day; lifetime maintenance dose; sample size ~ 100)

    “We examined the effectiveness of sodium fluoride in treatment of cochlear otospongiosis in ninety-four patients with cochlear otosclerosis and ninety-eight patients with stapedial otosclerosis and sensorineural hearing loss. The drug halted or slowed the progression of sensorineural hearing impairment in 63% of the patients with cochlear otosclerosis and 46% of the patients with stapedial otosclerosis. The single factor that best predicted which patients would respond most favorably to treatment was rate of progression before treatment. Sodium fluoride therapy was successful for 79% of the patients losing their hearing at a rate of 5 dB or more per year at one or more of the speech frequencies. The finding that patients with more rapid rates of progression responded most favorably to sodium fluoride therapy suggests that patients with the most active otospongiotic processes will be the most responsive to treatment.”

  • [Sodium fluoride therapy](")
  • The American Journal of Otology. Issue: Volume 14(5), September 1993, p 482–490

    A 1993 summary, encouraging use of sodium flouride.

When I asked my ENT who would be the best guy in the US should I elect to have a revision stapedectomy, that’s who he reccomended.

Maybe this will be able to help

http://www.walgreens.com/library/finddrug/druginfo1.html;jsessionid=8592CD161927CF2692883DD4AD90A5AE.b_01?particularDrug=Florical&id=2068

I am having the Stapedectomy done in two weeks. My Dr is in Warren Ohio and he specializes in doing them. He told me I have a 90% chance of success and I am excited to be able to hear much better. He put me on Florical with vitimin D. If anyone would like info on my dr, please contact me.

I just completed my appointment this past week suspecting Otosclerosis.
I went to Dr Lippy after reading an article in the Plain Dealer newspaper of Cleveland, Ohio. My %'s of success offered, were the same as well as the supplement with Florical.
I am confident of Dr. Lippy’s knowledge and experience; but do have reservations about his age. Although he seemed to keep pace with his full work load of the multitudes within his schedule, I found myself trying to see if his hands were steady enough to be in my head risking what little I had left. His walk was slightly hunched over and kept proclaiming over 17,000 Stapedectomy’s. Pictures on his office wall, of him and family about 20-30 years ago. But is he still sharp.
I am very curious of your thoughts, after having this surgery, of his continued skills.
Please respond. Scheduled in May for my first ear followed by the second shortly thereafter.
Thanks, George

Gee, now I have to contridict myself from my prior post. I had primary and revision stapedectomies from Dr.A Scheer in the late 90s. He was similar in stature and skill as Dr.Lippy is now. Scheer was a pioneer in the procedure, and had completed 21,000 procedures. He was at least 70 year old when he operated on me, but is was clearly still with it, and like you I watched his hands carefully and they were steady as a rock. Since I had revision, it goes without saying that the first surgery was not successful. The revision was also not sucessful. I believe I have an understanding of what happened on both and will not detail it here, but I believe the failure of the primary surgery was ‘operator error’ (with the surgeon being the operator). Likelyhood of success in the revision was slim with due to the nature of the failure of the first and the type of prostheric he uses (this was not known until the revision took place).

Lippy is certainly one of the most experienced to do this procedure, but I think you are wise to have reservations due to his age. I would ask him to give you IN WRITING his sucess rate in the LAST 500 procedures. Good luck whatever you decide.

P.S. My present ent thinks he has been so successful because his prosthetic is much better then Scheers.

My new Otolaryngologist believes that, had I been taking Florical regularly over the years, the nerve damage in my ears would not be as extensive.
I’ve been taking in for nearly 6 months and have not experienced any side effects. My family physician has no objections to this supplement so I’m not worried. I just wish I’d know about it much, much sooner.

I was prescribed Fluotic (sodium flouride) tablets when I was first diagnosed with otosclerosis several years ago. I took it for approximately a year along with a calcium supplement. It’s debatable whether it had any effect on the progression of the disease in my ear. I now have approximately 60dB conductive hearing loss and constant tinnitus.

I everybody, this would be my first post here, although, repeated google searches had me reading this forum many times, especially this thread. I’m from London and have been diagnosed with what they say is an 80% chance of Otosclerosis, whatever that means. I do know that I have lost considerable conductive hearing in a relatively short period. 35dB in my left ear over roughly six months and my right ear is catching up. Best of all, I’m a music producer, so no need to explain my depression.

Anyway, I have been frantically searching for recent information about Florical that contains some statistical hard facts, as did many of you. I found something dated 2006 that explains quite a lot, like what it is, what it does, how it works, the idea behind it, test study results, etc.

Here’s the link; it’s not a web page, it points to a word document and will prompt you to open or save it:
http://www.pharmagel.gr/downloads/CONSERVATIVE_TREATMENT_OF_OTOSCLEROSIS11.doc

Hope it helps clarify matters for some of you.

Awesome find!!!

My MD, who is an internationally recognized ear/hearing surgeon, recommended Fluoride supplementation to minimize otosclerosis progression. My understanding of his opinion is that, while research isn’t definitive on this (mostly done in Sweden?), there is evidence that Fluoride slows otosclerosis progression, it probably doesn’t stop it, and it certainly doesn’t reverse it. Given this, potential benefits far outweigh potential risks.

An aspect that I haven’t seen mentioned here is that otosclerosis not only causes conductive hearing loss, but it also usually contributes to neural hearing loss. So, those of us that have had a stapedectomy (both ears in my case; 2 R & 1 L) and have significant neural loss can still benefit from Fluoride.

I’ve been taking Monocal for approximately seven years. My only confusion pertains to Florical vs. Monocal. It appears that the only difference is that Florical contains Sodium Fluoride (yielding 3.75 mg Fluoride) while Monocal contains Sodium Monofluorophosphate (yielding 3 mg Fluoride). Anybody understand the difference and relative merits?

(Hz) L(dB) R(dB)
250 40 50
500 55 65
1K 55 60
2K 60 60
4K 70 70
8K 90 100
L: 88% SD@80dB
R: 64% SD@85dB
L&R stapedectomy

I was treated for 15-20 years by one of the researchers in medicinal treatment of otosclorosis, Dr.Ken Brookler. He did not make a distinction between flourical or monocal
but getting the right amount vitamin D was an important part of the treatment. He also used biphosphonates (osteoperosis medication). Someone posted an excellent paper on this in the last few months in this forum/topic, I suggest you search it out.

There’s some good evidence about the function of one of the D vitamins (D3 iirc) in relation to calcification/normal bone development.

Given that we all tend to spend so much time inside at this time of year, I’d also read that 1 in 5 had a chronic vitamin D shortage, with the relevant implications.

Sorry I haven’t got any sources, but it would make an interesting statistical study to try and correlate the degree of otosclerosis vs. vitamin D levels in the wider population.

I had a stapedectomy in my left ear in 1996 by world-known doctor in Warren. Results were wonderful. Had the right ear done in 1997 and results were terrible. Have tinnitus bad in right ear, and supposedly nerve damage. Be careful with surgery. I should have not had the second surgery. A red flag was the fact that they tested my hearing 4 times the day before that surgery to get the results they wanted. There is always a risk. Have been on florical ever since. But blood test shows I’m low in Vit. D - why the Dr. didn’t have me tested earlier for vit. D is a mystery. Only ordered the blood test after my last hearing test showed more loss. Now I am not sure about the sodium flouride in florical. New studies are pointing to it being cancer-causing. Do I really want to take a toxic, possibly cancer-causing chemical regularly over the years? Does that risk outweigh the risk of possibly progressive hearing loss? After both stapedectomies 13 and 14 years ago, I’m not sure I wouldn’t still be at this point today if I hadn’t had them. Tinnitus - everyone in my family has it. I wear hearing aids and wouldn’t be able to work without them. Am now experimenting, under the watchful eye of a well-informed ENT, with high quality supplements to reduce the tinnitus: magnesium, zinc, selenium, B-12 shots… 400 iu of vit. D isn’t enough. I am taking 4,000-6,000 D3 daily. If I have great results, will post again.

Because you went to the one of the best guys in the world (William Lippy) for Stapedectomy, not one of the best guys in the world for medicinal treatment of the disease! Dr.Lippy will prescribe florical but his real specialty is stapedectomies (revisions in particular).

As for your assertion that florical being a carcinogen, you can decide for youself:
http://www.health.gov/environment/reviewoffluoride/majfind.htm

There are many references on this site to qualified surgeons. You many have to travel to Ohio, Florida or other places. I am in NY City and I had 4 surgeries/revisions in NY City, but it was a while ago. If I were to have a stapedectomy or revision today it would probably not be here because most of the true specialists in this area are in other places. (There not nearly as many surgeons in NY City that I would trust as there were 15 years ago.)

If you have a 40 db air/bone gap, why are you not a candidate for surgery? Have you discussed surgery with a top specialist in this field?

I took that many years ago when my hearing took a nose dive. For me it stablized my hearing. I can’t remember how long I took it for, maybe a year. If I remember correctly it can waste away bones or something to that effect. I would do research to see if the risks outweigh the benefits. I thought for me it was worth trying. If I didn’t take it would my hearing kept getting worse rather than stable (for 7 yrs) no one can no for sure. Some countries have banned it. Research it.