Please STOP CIPROFLOXACIN DIPS and other antibiotics

[Tony Thompson]

Yes I know. Ilegal prescriptions get written quite frequently. Lots of Doctors will make judgement calls. In this case, it was a vet prescribing for an animal, not a vet prescribing for a human though. Your examples are different scenarios.

I personally find that shocking and extremely un professional practice and one that I would hope to be reported to the regulatory body concerned.

 

[Jay Hemdal]

As I am from the UK , I was very surprised at the apparent ease (within the USA) at which certain controlled medicines can be acquired.

To obtain these products by way of bypassing regulated suppliers may lead to inferior products and incorrect dosage, which could create a major concern, especially with regards unwanted development of anti biotic resistant strains. Zoonotic disease transfer is also a concern that should not be discounted lightly.

For traders within the aquarium trade contemplating or currently offering supply of the medicines detailed below (but not limited to) you may be in contravention of the USA FDA regulations.

My initial concern was there seemed to be a lack of regulation on the part of the FDA, however after further investigation I found this from the FDA website in the USA.


Below is an extract , edited to highlight relevant (to this discussion) statements.








"Issuing Office: Center for Veterinary Medicine
United States

WARNING LETTER

Date: October 6, 2020

RE: Unapproved New Animal Drug Products

RE: [610530]


"The FDA has observed"

"for sale in the United States veterinary products for the use in aquarium species, including Chloroquine Phosphate products. The claims"

"that these products are drugs under Section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act) [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals or because they are intended to affect the structure or function of the body of animals. Based on our review, as discussed below, these products are unapproved new animal drugs. An unapproved new animal drug is unsafe under section 512(a) of the FD&C Act [21 U.S.C. § 360b(a)] and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. Introducing or delivering for introduction into interstate commerce adulterated drugs violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]."

"Statements on your website that establish the intended uses of your products include, but are not limited to, the following:"


"Oxolinic acid"

"Chloroquine Phosphate Powder"

"Doxycycline Hyclate"

"Erythromycin Powder"

"Kanamycin Sulfate"

"Metronidazole Powder"

"Neomycin Sulfate Powder"

"Nitrofurazone Powder"

"Oxytetracycline Hydrochloride Powder"

"Based on our review, your products are for use in ornamental aquarium fish species, which are minor species as defined by sections 201(nn) and (oo) of the FD&C Act [21 U.S.C. §§ 321(nn) and (oo)]. As drugs for minor species, they are considered “new animal drugs” under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are not the subject of a final FDA regulation published through notice and comment rulemaking finding that the drug has been generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (“index listing”) under section 512, 571, or 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, or 360ccc-1]. The animal drugs named above have not been approved, conditionally approved, or index listed. Animal drugs that lack the required approval or index listing are "unsafe" and "adulterated" under sections 512(a) and 501(a)(5) of the FD&C Act [21 U.S.C. §§ 360b(a) and 351(a)(5)]. Introduction of an adulterated animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]."

"This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and injunction. You should notify this office, via e-mail, within the following timeframes, of the steps you are taking to correct any violations: Chloroquine Powder, Chloroquine Flake, and Chloroquine Pellets within two (2) working days of the receipt of this letter, all other products within fifteen (15) working days of the receipt of this letter. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within the above timeframes, state the reason for the delay and the time frame within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, please provide us with your reasoning and any supporting information for our consideration."



"Sincerely,

Mr. Eric M. Nelson
Director, Division of Compliance
Center for Veterinary Medicine
Food and Drug Administration"

Complete un edited letter can be found here https://www.fda.gov/inspections-com...ng-letters/everything-aquatic-610530-10062020

Those letters went out as a response to a news story here in the US where two people took aquarium chloroquine to try and "cure" Covid. One died I think. The FDA was called out for not controlling this, so they sent these letters to a few aquarium medication distributors.

As a side note - I got called into the media frenzy because I had written an online article on Chloroquine, and in it, I said it kills algae. Some reporter then took that and said that I said Chloroquine was an "aquarium cleaning agent". I got some ribbing for that (grin).

Aquarium drugs in the US have long been a gray area. There has been some regulation though. I remember back in the 1980's, using chloramphenicol (can cause aplastic anemia) was well as methyl testosterone on fish at a store I managed.

Jay

 

[Cell]

I personally find that shocking and extremely un professional practice and one that I would hope to be reported to the regulatory body concerned.

Meh, it's a pretty minor transgression compared to all the over prescribed pain killers and other antibiotics for human use.

 

[brandon429]

I don’t think for one second cipro use/guessing with antibiotics having no matched strain of bacteria at hand and short cutting any other reefing effort to regenerate inverts/ is going to stop, it’ll increase exponentially now that mainstream writers on reefbuilders put out a guesstimate dosage to the masses and directly show them that there’s no bother to match a target to an antibiotic, just dump it right in.
Customize the dose and sustain # of days as a whim


the majority of forum posters are happy to apply it, and can without any effort.

Over the next few years we simply watch it unfold, as creative non med techniques die out since laziness and instant gratification will please the masses much faster. They’ll get results alright, right along with diminishing returns and all our stock having been asexually produced for fifty generations with no genetic variation to inherently beat disease, without cheating, makes our stock weaker against disease. Anemone and sps diseases markedly uptick by 2027, prediction logged. It’ll take six metric tons of cipro per county to keep corals and inverts, petco will have flash sales by the 50 pound bag load as synthetic cipro analogs from China fill the demand. It’s orwelle’s missing chapter

 

[Tony Thompson]

Aquarium drugs in the US have long been a gray area. There has been some regulation though. I remember back in the 1980's, using chloramphenicol (can cause aplastic anemia) was well as methyl testosterone on fish at a store I managed.

Jay

Thanks Jay, I appreciate your explanation I was not aware of the other context link.

Personally I feel it shines some light (at least to myself) on the presence of FDA regulation over certain medicines commonly used in aquariums. I see these same medicines for sale on Ebay for importation into the UK, which directly contravenes UK regulations.

Although chloramphenicol in the UK is restricted to distribution through a pharmacist store, we don't need a prescription for this. I have obtained it myself over the counter for treating an eye infection. (Human).

It is very interesting point about the chloroquine based medicines being applicable as an algicide. I read that whilst doing my search, thanks for validating that.

Tony.

 

[MnFish1]

Meh, it's a pretty minor transgression compared to all the over prescribed pain killers and other antibiotics for human use.

Come on. No it's not. You do not understand how bacterial resistance evolves - I would suggest - with all due respect - google how bacterial resistance is transferred. Look - I'm ok with copper, praziquantel. However using other antibiotics not so much

 

[Cell]

Come on. No it's not. You do not understand how bacterial resistance evolves - I would suggest - with all due respect - google how bacterial resistance is transferred. Look - I'm ok with copper, praziquantel. However using other antibiotics not so much

There is a bit more involved than just bacterial resistance when discussing the over use/prescribing of painkillers. I don't see anyone getting addicted to cipro. I would suggest researching the opiate epidemic.

Nor do you know what i do or do not have knowledge of.

 

[Tony Thompson]

There is a bit more involved than just bacterial resistance when discussing the over use/prescribing of painkillers. I don't see anyone getting addicted to cipro. I would suggest researching the opiate epidemic.

Nor do you know what i do or do not have knowledge of.

I think I already mentioned this on this thread or maybe I am getting confused as I am discussing this across multiple platforms.

The series Dopesick is a great example how failure by a regulatory body (in this case through suspected criminal activity) produced a devastating impact on USA communities from oxycotin , all due to the evil greed of pharma companies like Purdue and the Sackler Family. Also interesting point is that the Pharma company in question found it impossible to get regulation in Europe for there drug.

However I feel you have compared two completely different regulations. Prescribing controlled Veterinary or Human medicines without following the legal protocols for such prescription and supply is more directly open to legal action by either the criminal law or medical regulatory board than the much more variable conclusions made from that of dosage or drug selection.

Illegal use (dependant on countries regulations) of the prescription protocols is a serious offence and rightly so.

 

[zoomonster]

Truly interesting thread. I've never treated with human antibiotics but thought about cipro for Euphyllia BJD. But I haven't for a variety of reasons like not having access although I have personally been prescribed cipro by my ENT several times.

Then as I was looking guess what popped up on here as an ad? thefishaid.com selling a wide variety of american made antibiotics "for fish and aquariums" with NO PRESCRIPTON needed. I was kind of shocked at everything from penicillin to cipro in human level doses. Guess drugs in the aquarium have gone mainstream and are here to stay whether good or bad.

 

[Muffin87]

You are absolutely right.
I’m wondering if there would be any way to inactivate the antibiotic after the dip.
im imagining a situation where someone would like to save a prized euphullia without just dumping active ciproflaxin down the drain.

Is there no way to force a degradation of Cipro within the water after you’re done with dipping?
It’s not nuclear waste, so I’d imagine there may be a way to inactivate ciproflaxin before discarding it.

 

[zoomonster]

You are absolutely right.
I’m wondering if there would be any way to inactivate the antibiotic after the dip.
im imagining a situation where someone would like to save a prized euphullia without just dumping active ciproflaxin down the drain.

Is there no way to force a degradation of Cipro within the water after you’re done with dipping?
It’s not nuclear waste, so I’d imagine there may be a way to inactivate ciproflaxin before discarding it.

As I understand it antibiotic dips don't cut it. Most people dose cipro, in tank, daily at night for 7-10 days. During the daytime lights will break it down as will ozone. Plus, if skimmer on, carbon in its going to remove it.

 

[Muffin87]

As I understand it antibiotic dips don't cut it. Most people dose cipro, in tank, daily at night for 7-10 days. During the daytime lights will break it down. Plus, if skimmer on, ozone on, carbon in its going to remove it.

You can just use a five gallon tank for a 7-10 days treatment.

 

[Cell]

I think I already mentioned this on this thread or maybe I am getting confused as I am discussing this across multiple platforms.

The series Dopesick is a great example how failure by a regulatory body (in this case through suspected criminal activity) produced a devastating impact on USA communities from oxycotin , all due to the evil greed of pharma companies like Purdue and the Sackler Family. Also interesting point is that the Pharma company in question found it impossible to get regulation in Europe for there drug.

However I feel you have compared two completely different regulations. Prescribing controlled Veterinary or Human medicines without following the legal protocols for such prescription and supply is more directly open to legal action by either the criminal law or medical regulatory board than the much more variable conclusions made from that of dosage or drug selection.

Illegal use (dependant on countries regulations) of the prescription protocols is a serious offence and rightly so.

Illegal use of prescription protocols may be a serious offense but every example of a prescription being written "under the table" is not the same level of offense, in my opinion. A veterinarian writing a cipro prescription for an allegedly sick nem vs a MD writing a painkiller prescription for an alleged issue, for instance.

Your reaction to my account of how I acquired cipro was shock, disgust, and the belief someone should be reported to the proper authorities. I don't think it's quite that level of transgression and was providing an example that falls under the same umbrella but is far more serious/damaging.

 

[Cell]

I'm reminded of the use of Interceptor, a canine heartworm medication. It's pretty much the go to recommendation for black bugs on this forum and requires a prescription.

 

[Cell]

Come on. No it's not. You do not understand how bacterial resistance evolves - I would suggest - with all due respect - google how bacterial resistance is transferred. Look - I'm ok with copper, praziquantel. However using other antibiotics not so much

Out of curiosity, why are you ok with PZQ?

 

[MnFish1]

There is a bit more involved than just bacterial resistance when discussing the over use/prescribing of painkillers. I don't see anyone getting addicted to cipro. I would suggest researching the opiate epidemic.

Nor do you know what i do or do not have knowledge of.

LOL you're correct the opioid epidemic has nothing to do with this discussion. Instead someone brought it up as a false equivalence.

 

[MnFish1]

As I understand it antibiotic dips don't cut it. Most people dose cipro, in tank, daily at night for 7-10 days. During the daytime lights will break it down as will ozone. Plus, if skimmer on, carbon in its going to remove it.

There is no evidence that 1) the cipro is totally eliminated..inactivated with their own individual method 2). that whatever they are trying to treat is caused by cipro sensitive organisms. 3) that the duration of treatment is effective.

If - in fact people are doing this - trying to use a pulse cipro treatment - it's probably more as compared to less likely to reduce resistance. In any case its no offense - nonsense IMHO

 

[MnFish1]

Out of curiosity, why are you ok with PZQ?

Parasite resistance is much slower (if it does) - due to the much slower doubling times.

 

[alprazo]

I just want to add a little additional context. When cipro or another antibiotic is diluted as it is flushed or dumped down a drain, the concentration will drop to what is called “sub microbial”. Physicians / dentists commonly use doxycycline at submicrobial doses to reduce inflammation in periodontal disease or chronic inflammatory diseases of the skin like rosacea. It has been shown that these low doses do not confer resistance. There is no pressure on bacterial survival and therefore selection does not occur. So yes, though resistance is of great concern, unless we are concerned of resistant Mycobacterium marinum or Vibrio vulnificus, the limited use of cipro in tanks is a minor concern.

 

[Jay Hemdal]

I just want to add a little additional context. When cipro or another antibiotic is diluted as it is flushed or dumped down a drain, the concentration will drop to what is called “sub microbial”. Physicians / dentists commonly use doxycycline at submicrobial doses to reduce inflammation in periodontal disease or chronic inflammatory diseases of the skin like rosacea. It has been shown that these low doses do not confer resistance. There is no pressure on bacterial survival and therefore selection does not occur. So yes, though resistance is of great concern, unless we are concerned of resistant Mycobacterium marinum or Vibrio vulnificus, the limited use of cipro in tanks is a minor concern.

I had never heard of "submicrobial dosing" and it seemed to fly against everything I had been taught about ABX in the environment. I looked up the topic and scanned a paper on periodontal disease and found this text in the results section:

Based on median values, a higher percentage of the total recovered flora was resistant to 4 μg doxycycline per milliliter at 24 months (43.19%) compared to baseline (4.99%) in the SDD treatment group, whereas there was little change in the placebo group over time (from 4.89% at baseline to 5.44% at 24 months). This difference in change over time between the two treatment groups was statistically significant (P <0.001).

So - to my read, the dose regimen caused a 10x increase in doxycycline resistance?

The paper does do on to say that since this is a low dose resistance, doxy can still be used at higher breakpoints, but I say that's disingenuous at best, and they are just promoting their novel therapy.... "just use a higher dose" is NOT a proper response to bacterial resistance.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2041927/



Jay