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resources:fluoroquinolones [2018/01/28 23:37]
bpaddock Added Wayback Machine link to 617 page FDA paper They removed.
resources:fluoroquinolones [2018/12/14 02:15] (current)
bpaddock Updated PRAC formating.
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 http://​www.newsnet5.com/​news/​local-news/​investigations/​levaquin-fda-fails-to-disclose-additional-serious-side-effects-of-antibiotic-linked-to-deaths is my Cleveland/​Akron TV interview. ​ 3,000 dead. 200,000 injured by these drugs per the FDA.  That is estimated to be only one-percent of the real numbers! http://​www.newsnet5.com/​news/​local-news/​investigations/​levaquin-fda-fails-to-disclose-additional-serious-side-effects-of-antibiotic-linked-to-deaths is my Cleveland/​Akron TV interview. ​ 3,000 dead. 200,000 injured by these drugs per the FDA.  That is estimated to be only one-percent of the real numbers!
  
-The News Net5 [[http://media.newsnet5.com/uploads/FDA%20Levaquin%20Study.pdf?_ga=2.20065528.1905100486.1496067768-329681201.1494769142|FDA Report]].+The News Net5 {{ :​resources:​fluoroquinolones:​fda_levaquin_study.pdf |FDA Report}}. 
 + 
 +Try this link if the video does not play at the above link then try this locally served file, as IT at News Net5 keeps breaking the link: 
 + 
 +{{ :​resources:​fluoroquinolones:​levaquin_fda_fails_to_disclose_additional_serious_side_effects_of_antibiotic_linked_to_deaths_newsnet5.com_cleveland.mp4 |}} 
 + 
 +</​WRAP>​ 
 + 
 +---- 
 + 
 +<WRAP warning>​ 
 +====== FDA updates warnings [AGAIN!] for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions ====== 
 + 
 +<​blockquote>​ 
 + 
 +For Immediate Release July 10,2018 
 + 
 +Release: The U.S. Food and Drug Administration today is requiring safety labeling changes for a class of antibiotics called fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances,​ and make these warnings more consistent across the labeling for all fluoroquinolones taken by mouth or given by injection. 
 + 
 +“The use of fluoroquinolones has a place in the treatment of serious bacterial infections — such as certain types of bacterial pneumonia — where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option. The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. 
 + 
 +FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela). There are more than 60 generic versions. The safety labeling changes the FDA is requiring today were based on a comprehensive review of the FDA’s adverse event reports and case reports published in medical literature. 
 + 
 +Across the fluoroquinolone antibiotic class, a range of mental health side effects are already described in the Warnings and Precautions section of the drug labeling, but differed by individual drug. The new class-wide labeling changes will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class. The mental health side effects to be included in the labeling across all the fluoroquinolones are disturbances in attention, disorientation,​ agitation, nervousness,​ memory impairment and delirium. 
 + 
 +Additionally,​ the recent FDA review found instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia. As a result, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia. 
 + 
 +Today, the FDA also published a [[https://www.fda.gov/Drugs/DrugSafety/​ucm611032.htm|drug safety communication]] about safety information regarding hypoglycemic coma and mental health side effects with fluoroquinolones. 
 + 
 +The FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon ruptureIn February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed WarningIn August 2013, the agency required updates to the labeling to describe the potential for irreversible peripheral neuropathy (serious nerve damage). 
 + 
 +In 2016, the FDA [[https://​www.fda.gov/​Drugs/​DrugSafety/​ucm500143.htm|enhanced warnings]] about the association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous systemBecause the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options. 
 + 
 +The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines. 
 + 
 +The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness,​ security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements,​ products that give off electronic radiation, and for regulating tobacco products. 
 + 
 +</​blockquote>​ 
 + 
 +security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements,​ products that give off electronic radiation, and for regulating tobacco products. 
 + 
 +### 
 +Release: ​ The U.S. Food and Drug Admini 
 +### -- https://​www.fda.gov/​newsevents/​newsroom/​pressannouncements/​ucm612995.htm 
 +</​blockquote>​ 
 </​WRAP>​ </​WRAP>​
  
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 For Immediate Release July 26, 2016 For Immediate Release July 26, 2016
- +
 Release: ​ The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics,​ called fluoroquinolones,​ to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. Release: ​ The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics,​ called fluoroquinolones,​ to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.
  
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 </​WRAP>​ </​WRAP>​
----- 
  
 ---- ----
 +<WRAP important>​
 +====== European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics ======
 +
 +November 16 2018:
 +
 +<​blockquote>​...Importantly,​ fluoroquinolones should generally be **avoided** in patients who have previously had
 +serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with **special
 +caution** in the elderly, patients with kidney disease and those who have had an organ transplantation
 +because these patients are at a higher risk of tendon injury. //Since the use of a corticosteroid with a
 +fluoroquinolone also increases this risk, combined use of these medicines should be avoided//​...</​blockquote>​ -- 
 +//​[[https://​www.ema.europa.eu/​en/​medicines/​human/​referrals/​quinolone-fluoroquinolone-containing-medicinal-products|Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics]]//​ [ [[https://​www.ema.europa.eu/​documents/​referral/​quinolone-fluoroquinolone-article-31-referral-disabling-potentially-permanent-side-effects-lead_en.pdf|PDF]] ].
 +
 +October 5th 2018:
 +
 +<​blockquote>//​Fluoroquinolone and quinolone antibiotics:​ PRAC recommends new restrictions on use following review of disabling and potentially long-lasting side effects Share//
 +
 +Press release 05/10/2018 [October 5th 2018]
 +
 +The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics (used by mouth, injection or inhalation) following a review of disabling and potentially long-lasting side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.
 +
 +Very rarely [**//__THIS IS NOT TRUE, NOT RARE AT ALL__//**], patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons and bones and the nervous system. ​  
 +
 +<​blockquote>​**Following its evaluation of these side effects, the PRAC has recommended that some medicines, including all those that contain a //quinolone antibiotic//,​ should be removed from the market. This is because they are authorised only for infections that should no longer be treated with this class of antibiotics.**</​blockquote>​
 +
 +The PRAC recommended that the remaining fluoroquinolone antibiotics should:
 +
 +**not** be used
 +  * to treat infections that might get better without treatment or are not severe (such as throat infections);​
 +for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
 +  * to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic;
 +  * to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used;
 +  * be used with caution especially for the elderly [They should not be used in the elderly at all], patients with kidney problems, patients who have had an organ transplantation or those who are being treated with a systemic corticosteroid. These patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.
 +
 +The PRAC also recommended that healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).</​blockquote>​ -- [[https://​www.ema.europa.eu/​en/​news/​fluoroquinolone-quinolone-antibiotics-prac-recommends-restrictions-use|https://​www.ema.europa.eu/​en/​news/​fluoroquinolone-quinolone-antibiotics-prac-recommends-restrictions-use]] [ [[https://​www.ema.europa.eu/​documents/​press-release/​fluoroquinolone-quinolone-antibiotics-prac-recommends-restrictions-use_en.pdf|PDF]] ]
 +
 +June 13th 2018:
 +
 +[[https://​www.ema.europa.eu/​en/​medicines/​human/​referrals/​quinolone-fluoroquinolone-containing-medicinal-products#​public-hearing-section|Four hour long Public Hearing]]
 +
 +{{youtube>​1vao8o5NGUc}}
 +
 +</​WRAP>​
 +
 <WRAP important>​ <WRAP important>​
 ====== Our Win at the FDA hearing on Fluoroquinolone Antibiotics. Links to FDA's 617 page FQAD report and the hearing videos ====== ====== Our Win at the FDA hearing on Fluoroquinolone Antibiotics. Links to FDA's 617 page FQAD report and the hearing videos ======
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 Other fluoroquinolones related publications and sites: Other fluoroquinolones related publications and sites:
 +
 +----
 +
 +[[https://​biology.stackexchange.com/​questions/​69563/​are-fluoroquinolone-antibiotics-cipro-levaquin-etc-chemotherapy-drugs|Are fluoroquinolone antibiotics (Cipro, Levaquin, etc) chemotherapy drugs?]]
 +
 +<​blockquote>​Short answer: Yes, fluoroquinolones are chemotherapy drugs
 +In layman'​s terms, fluoroquinolone antibiotics kill human cells as they divide. Fluoroquinolones are a class of drug called "​topoisomerase interrupters."​ Every drug in this class is directly labeled as a chemotherapy drug except fluoroquinolones.
 +
 +This is not well known by the medical community and is in part why irreversible damage from fluoroquinolone antibiotics is not well understood.
 +
 +Long answer: Fluoroquinolones are definitely chemotherapy drugs, and they'​re dangerous...</​blockquote>​
 +
 +----
 +
 +
  
 ===== Dear Doctor ===== ===== Dear Doctor =====