resources:fluoroquinolones

Differences

This shows you the differences between two versions of the page.

Link to this comparison view

Both sides previous revision Previous revision
Next revision		 Previous revision
Next revision
resources:fluoroquinolones [2017/07/23 13:23]
bpaddock [Ten Pages of Warnings for Levaquin] 		resources:fluoroquinolones [2018/12/11 02:14]
bpaddock Locally serve the News Net5 Video.
Line 48: Line 48:
 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 rupture. In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. In 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 system. Because 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>
  
Line 59: Line 104:
  
 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.
  
Line 82: Line 127:
  
 </WRAP> </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 ======
Line 90: Line 135:
 Please see: //**[[:blog/bpaddock/win_at_the_fda_hearing_on_fluoroquinolone_antibiotics|Our Win at the FDA hearing on Fluoroquinolone Antibiotics]]**// for details and videos of the hearing at the FDA on November 5th 2015. Please see: //**[[:blog/bpaddock/win_at_the_fda_hearing_on_fluoroquinolone_antibiotics|Our Win at the FDA hearing on Fluoroquinolone Antibiotics]]**// for details and videos of the hearing at the FDA on November 5th 2015.
  
-FDA Hearing [[http://www.fda.gov/AdvisoryCommittees/Calendar/ucm465275.htm|meeting brief]] and the [[http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM467383.pdf|617 page PDF]] report where the the FDA identified a syndrome associated with fluoroquinolone toxicity—one that “floxies” have been pushing for recognition of for years. It is called Fluoroquinolone Associated Disability (FQAD).+FDA Hearing [[http://www.fda.gov/AdvisoryCommittees/Calendar/ucm465275.htm|meeting brief]] and the [[https://web.archive.org/web/20170113234645/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM467383.pdf|617 page PDF; (Note the FDA removed this document from their website.  Fill in your own Conspiricy Theory)]] report where the the FDA identified a syndrome associated with fluoroquinolone toxicity—one that “floxies” have been pushing for recognition of for years. It is called Fluoroquinolone Associated Disability (FQAD).
 </WRAP> </WRAP>
 ---- ----
Line 183: Line 228:
  
 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 =====
Line 479: Line 539:
 Our mission is to help our users evaluate if they have a legal case because of life-changing side effects or complications that were caused by a device maker or a drug company. We are sponsored by The Peterson Firm, a Washington, D.C., law firm, and we use the legal team at The Peterson Firm to educate these users about their circumstances. If a user expresses interest in speaking with a lawyer about bringing a legal case, a Patient Advocate may suggest a law firm to work with The Peterson Firm on the case. If a user retains the firms to handle his or her case, both firms will work on a contingency fee basis, with no costs or fees charged unless a recovery is made. Your Patient Advocate can explain the process in more detail. Our mission is to help our users evaluate if they have a legal case because of life-changing side effects or complications that were caused by a device maker or a drug company. We are sponsored by The Peterson Firm, a Washington, D.C., law firm, and we use the legal team at The Peterson Firm to educate these users about their circumstances. If a user expresses interest in speaking with a lawyer about bringing a legal case, a Patient Advocate may suggest a law firm to work with The Peterson Firm on the case. If a user retains the firms to handle his or her case, both firms will work on a contingency fee basis, with no costs or fees charged unless a recovery is made. Your Patient Advocate can explain the process in more detail.
 </blockquote> </blockquote>
- 
  • resources/fluoroquinolones.txt
  • Last modified: 2020/07/14 14:19
  • by bpaddock