Enrofloxacin Addition in FMD vaccine: An anti-national act

An Anti-National Act of Dr. Gaya Prasad Committee on FMD Vaccine quality issue formed by GOI (ICAR) wrote that "Enrofloxacin Addition in FMD vaccine is legal and with no undesirable effects"

The Committee wrote in their report (https://www.researchgate.net/publication/267705649_Testing_of_FMD_Vaccine_intended_to_be_used_under_FMD-CP_of_Govt_of_India_at_CCS_NIAH_Baghpat_UP_India?ev=post) on FMD Vaccine Quality at page 9 at point 4: “Ït was informed by the manufacturer that the use of enrofloxacin as a preservative was permitted by DCGI (Annexure 7). The Committee was told that the concentration used does not have undesirable effects.”

From this statement, it is apparent that they believed on the manufacturer of the substandard vaccine adulterated with unethically permitted antibiotic as the preservative. They neither did any search, nor research nor had any knowledge. They went to the extremes to support the addition of the antibiotics (in low doses) which may destroy the ecology, environment and coming generations of India. They become blind or got blinded with ----power, only Dr. Gaya Prsad can explain the reasons for his blindness.

If they would have read even the single drug datasheet of enrofloxacin (https://animalhealth.bayer.com/ah/fileadmin/media/baytril/pdf_companion/kap6.pdf) from mother company (Bayer) then they would have changed their view. But the committee was made illiterate by the corporate power.

I request you to read the following lines from http://c.ymcdn.com/sites/www.aavpt.org/resource/resmgr/imported/fluoroquinolones.pdf

Federal law prohibits the extra-label (non-intended use) use of fluoroquinolones in food-producing animals (21 CFR 530.41). The prohibition is based on a finding by the Food and Drug Administration (FDA) that the extra-label use of these antibiotics in food-producing animals presents a risk to the public health because it could increase the level of drug-resistant zoonotic pathogens at the time of slaughter. Some researchers are concerned that such use can lead to the transfer of pathogens resistant to fluoroquinolones from animals to human beings. Food animals including, all pigs, feedlot cattle and, animals that are not members of a species routinely used for food production would also be considered food-producing animals if they or their products are processed for human consumption.

But in India neither animals nor human lives are valuable; it seems to be the country of money-money and money, of corporate houses and of traitors.

Extra-label drug use (ELDU) means "actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labelling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses." (http://www.farad.org/eldu/eldumain.asp; http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ActsRulesRegulations/ucm085377.htm). And to your surprise, you may not find the use of enrofloxacin as a preservative. The enrofloxacin is “- Only labelled for non-lactating dairy animals twenty months of age or less and beef animals for pneumonia.” (See page 21 of the link: http://www.nationaldairyfarm.com/sites/default/files/2015-Residue-Manual-WEB.pdf) and is not approved in lactating dairy cattle 20 months of age or older (page 52 of the above link).

Dr. Dr. Clell V. Bagley, D.V.M. wrote (http://extension.usu.edu/dairy/files/uploads/htms/drugs.htm) “Fluoroquinolones - Although data have not been sufficiently conclusive to prevent approval of sarafloxacin for chickens and beef cattle, it prompted FDA-CVM to prohibit the extra-label use of these compounds in 1997. Fluoroquinolone products labelled for either humans or companion animals may not be used in food animals. Any deviation from a food animal label (such as use with a different species, dosage, route of administration, or disease indication) is similarly illegal. In the case of the approved beef cattle formulation of enrofloxacin (Baytril 100), this prohibition extends to all non-beef-production animals, including lactating and nonlactating dairy cows, heifer replacements, and veal calves. Enrofloxacin may not be stored in dairy farm drug cabinets”.

The fluoroquinolones were the first group of antimicrobials prohibited from extra-label use by the FDA because of their potential for creating antimicrobial-resistant strains that posed a threat to human health. The FDA banned the extra-label use of fluoroquinolones in 1997. Not only in dairy animals FDA, in 2005, withdrew the approval for enrofloxacin products in poultry and effectively made use of these drugs in poultry species illegal (http://www.farad.org/publications/digests/092009ProhibitedDrugsUpdated.pdf).

The dangers of enrofloxacin use in animals even those are not food animals are as under (http://www.wedgewoodpetrx.com/learning-center/professional-monographs/enrofloxacin-for-veterinary-use.html):

• Enrofloxacin and the other fluoroquinolones antibiotics can cause developmental cartilage abnormalities. As a consequence, most veterinarians try to avoid these drugs in young animals.

• Enrofloxacin should be used with caution or avoided in animals at risk for seizures. This drug is not used in humans due to central nervous system stimulation.

• Enrofloxacin should not be used for regional antibiotic perfusion because it is too irritating and will cause vasculitis.

• In Dogs: GI side-effects including vomiting, diarrhoea and elevated liver enzymes; Rare CNS signs including ataxia, seizures, depression, and anxiety, not recommended in pups.

• In Cats: GI side effects include vomiting, diarrhoea, anorexia, elevated liver enzymes. CNS signs include ataxia, seizures, depression, vocalization, and aggression. Rare ocular toxicity may occur.

• In Horses: As Injection, it is highly irritant and when given orally it can cause mucous membrane irritation, redness, slobbering, and swelling.

• All food animals: Prohibited

                    Dear Friends, low dosages of antibiotics are even more dangerous than the therapeutic use of the antibiotics because “Low doses of antibiotics can stimulate the formation of bacterial biofilms that lead to chronic lung, sinus, and ear infections. The biofilms can grow stronger instead of weaker in presence of the antibiotics. The emergence of drug-resistant bacteria is a global challenge and is an outcome of the irregular and subtherapeutic use of antibiotics besides several other factors.

            So be careful and think twice about the explanation of Dr. Gaya Prasad Committee, either its addition into FMD vaccine supported by the committee is wise or anti-national.

The common adverse effects of Fluoroquinolones (ciprofloxacin, norfloxacin, ofloxacin, enrofloxacin, levofloxacin etc, FQ) include gastrointestinal disorders as nausea, vomiting, diarrhoea, and abdominal cramps. Besides, skin rashes, allergies, and photosensitivity are also frequently seen. Some less common complications of FQ use are neutropenia, eosinophilia, and elevated liver enzymes (1-4%) but luckily all are reversible with proper post-therapeutic care (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668199/). Several studies associated arthropathy in kids after use of FQ in growing age up to 18 years.

In a study in 2003, Chalumeau and co-workers reported (https://www.ncbi.nlm.nih.gov/pubmed/12777590) from a prospective, multicenter, observational, cohort study that compared potential adverse events in 276 pediatric patients who received FQs and 249 matched controls who received an antibiotic agent other than FQ. The chances for potential adverse events in the FQ group were 3.7 times more than the non-FQ group. The most commonly affected systems were the gastrointestinal followed by musculoskeletal (arthralgias of large joints or myalgias but no tendinopathy), skin, and central nervous systems.

The recent model list of essential drugs prepared by the WHO includes only 340 items and 532 formulations of which only 12 are FDCs(2). The combination of metronidazole and norfloxacin does not figure in this list (https://www.indianpediatrics.net/sep1998/sep-941-942.htm), but in India, you may find in almost every pediatric prescription (http://www.drugsupdate.com/brand/showavailablebrands/631), often as the first drug of life.

When the use of FQs is permitted?
Even the most studies supporting the use of fluoroquinolones to cure septic cases in kids when no other alternative is left agree with the bad effects of fluoroquinolones in kids (http://www.jwatch.org/em200712210000003/2007/12/21/should-we-prescribe-fluoroquinolone-antibiotics).

FQs are approved by FDA and EU (https://www.ncbi.nlm.nih.gov/pubmed/21949152; https://ec.europa.eu/health//sites/health/files/files/paediatrics/2012-09_pediatric_report-annex1-2_en.pdf; http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Ciprofloxacin_Bayer/human_referral_000024.jsp) for use in children for emergency use for the treatment of inhalation anthrax, complicated urinary tract infections, and pyelonephritis and cystic fibrosis caused by Pseudomonas aeruginosa. WHO permits FQs (http://www.who.int/maternal_child_adolescent/documents/9241546700/en/) for the treatment of life-threatening bacterial infections, such as resistant tuberculosis, dysentery, and cholera, with the caution that uses these nasty antibiotics if the benefits outweigh the risk of arthropathy. American Academy of Pediatrics (AAP) suggest the use of FQs for treatment of multidrug-resistant infections for which there is no safe and effective alternative, and when parenteral therapy is not feasible and no other effective oral agent is available (https://www.ncbi.nlm.nih.gov/pubmed/16951028).

 But who cares in India, paediatricians are prescribing these FQ drugs indiscriminately even giving any second thought and using it as the first line of treatment which otherwise should be the last option.