Fluoroquinolone research + cases pending

# Fluoroquinolone


https://web.archive.org/web/20161024181221/http://thesandersfirm.com/dangerous-drugs/fluoroquinolones-lawsuits/


 studies
Several studies reveal the dangers inherent in these widely-prescribed antibiotics:

    A 2001 study published in the Annals of Pharmacotherapy found that 71 percent of the fluoroquinolones users with peripheral neuropathy symptoms had trouble with multiple organ systems three months later and 58 percent still struggled a year later.
    A 2012 study published in the Journal of the American Medical Association linked blinding retinal detachment with antibiotic use. Researchers concluded that “patients taking oral fluoroquinolones were at a higher risk [3.3% in antibiotic users vs. 0.6% in controls] of developing a retinal detachment, compared with nonusers, although the absolute risk [4 in 10,000] for this condition was small.”
    A 2013 study published in the Canadian Medical Association Journal found a 2.18-fold increased rate of acute kidney injury among current fluoroquinolone users. The risk was more pronounced in men taking renin–angiotensin-system blockers.
    In 2014, University of Rhode Island researchers looked at the risk of hepatoxicity among fluoroquinolones users and found that “fluoroquinolone use was significantly associated with a 20% increased risk of hepatotoxicity development compared to non-users.” They found the risk was even more significant with ciprofloxacin use, compared to levofloxacin and moxifloxacin.

FDA cautions about fluoroquinolone side effects

The FDA issued a warning in August 2013 that required manufacturers to add peripheral neuropathy as a risk on all labeling. The new black box warning labels stated that nerve damage can occur almost immediately upon taking the drugs — with permanent effects. The link to tendinitis and tendon rupture are also included.

On November 5, 2015, an FDA review panel from the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted overwhelmingly that risks associated with fluoroquinolone antibacterial drugs support a need for a label change.

A large number of patients reported “a constellation of symptoms” known as Fluoroquinolone-Associated Disability (FQAD) – which may include peripheral neuropathy, skin disorders, sensory disturbances, cardiovascular events, neuropsychiatric disorders and musculoskeletal issues. Most patients were previously healthy and took the antibiotics for urinary tract infections, bronchitis or sinusitis – which could have been treated with other types of drugs – and now suffer “a substantial disruption of their normal life functions” with pain, difficulty moving and issues with involuntary functions like breathing, digestion and circulation. After reviewing the panel’s findings, the FDA may choose to release an updated safety communication and/or request a new black box warning on the labels of drugs like Levaquin and Cipro.
Pending litigation in federal courts

There are two federal cases regarding fluoroquinolone drugs pending in the multidistrict litigation in Minnesota, presided over by Justice John R. Tunheim. As of November 2015, there were about 10 cases still pending in MDL 1943 — with all others settled or dismissed.

About 225 lawsuits are still pending in MDL 2642, which includes Levaquin, Avelox and Cipro cases related to irreversible peripheral neuropathy and nerve damage.
 Plaintiffs are suing on the following counts:

    Strict Liability – Defendants knew their drugs posed unreasonable risks, but continued to sell the products with inadequate warnings anyway.
    Failure to Warn – Defendants negligently failed to warn patients of known side effects
    Negligence – Defendants breached their duty to properly conduct post-market testing and surveillance to ensure safety
    Fraud – Defendants actively concealed irreversible dangers of their drugs



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https://web.archive.org/web/20190419194901/https://www.masstortnexus.com/Briefcases/Drugs/37/FLUOROQUINOLONES-MDL-2642


Briefcases -- Drugs --  (Avelox, Cipro, Levaquin) MDL 2642 USDC Minnesota
FLUOROQUINOLONES (Avelox, Cipro, Levaquin) MDL 2642 USDC Minnesota
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https://web.archive.org/web/20190419194919/https://unicourt.com/case/pc-db1-wohl-v-bayer-corporation-et-al-849875

Wohl V. Bayer Corporation Et Al


Case Summary

On 09/10/2018 a Personal Injury - Medical/Pharmaceutical Product Liability case was filed by Wohl against Bayer Corporation in the jurisdiction of U.S. District Courts, Minnesota District.



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https://web.archive.org/web/20181210065759/https://www.drugwatch.com/cipro-levaquin-avelox/lawsuits/


    September 18, 2018

Fluoroquinolones Pulled from Market

For years, fluoroquinolones have been linked to serious side effects. In fact, many fluoroquinolones have been removed from the U.S. market because of their risks.
Brand 	Date Removed From Market 	Risks That Prompted Removal
Omniflox® (temafloxacin) 	June 1992 	low blood sugar, kidney failure, rare form of anemia
Trovan® (trovafloxacin) 	June 1999 	severe liver toxicity
Raxar® (grepafloxacin) 	October 1999 	QT-interval prolongation
Zagam® (sparfloxacin) 	July 2001 	QT-interval prolongation
Tequin® (gatifloxacin) 	May 2006 	severe blood sugar reactions such as hyperglycemia and hypoglycemia
Levaquin 	December 2017 	Company denies removal tied to risk
Floxin 	December 2017 	Company denies removal tied to risk



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fluoroquinolones


21 Cited Research Articles

    Wheatley, A. (2018, July 19). Email to Drugwatch.com re discontinuation of Levaquin.
    Johnson & Johnson. (2017, October 17). Johnson & Johnson Reports 2017 Third-Quarter Results. Retrieved from http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=1044155
    U.S. District Court Middle District of Florida. (2016, June 8). Ronald Vaughn v. Johnson & Johnson et al. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2016-06-08-Vaughn-Complaint.pdf
    U.S. District Court Southern District of New York. (2016, September 30). Benn Prybutok v. Johnson & Johnson et al. Retrieved from http://www.pacer.gov
    U.S. District Court District of Minnesota. (2014, September 11).Final Pretrial Order and Suggestion of Remand. Retrieved from http://www.mnd.uscourts.gov/MDL-Levaquin/Pretrial_Minutes/2014/2014-0911-Final-PTO-and-suggestion-of-remand.pdf
    U.S. Judicial Panel on Multidistrict Litigation. (2015, August 17). Transfer Order. Retrieved from http://www.pacer.gov.
    U.S. District Court District of Minnesota. (2017, April 5). Retrieved from http://www.mnd.uscourts.gov/MDL-Fluoroquinolone/current-developments.shtml
    U.S. District Court District of Minnesota.(n.d.). Fluoroquinolone MDL | 15-MD-2642. Retrieved from http://www.mnd.uscourts.gov/MDL-Fluoroquinolone/index.shtml
    U.S. District Court District of Minnesota. (n.d.). Levaquin MDL | 08-MD-1943. Retrieved from http://www.mnd.uscourts.gov/MDL-Levaquin/index.shtml
    Do, T. (n.d.). Johnson & Johnson, former FDA commissioner among defendants in Levaquin lawsuit. Retrieved from http://www.abc2news.com/news/in-focus/johnson-johnson-former-fda-commissioner-among-defendants-in-levaquin-lawsuit
    Daneman, N. et al. (2015). Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study. BMJ. Retrieved from http://bmjopen.bmj.com/content/5/11/e010077.full
    Boyles, S. (2015, October 7). Fluoroquinolones May Increase Aortic Aneurysm Risk. MedPage Today. Retrieved from http://www.medpagetoday.com/Cardiology/Prevention/53950
    Lee, C. et al. (2015). Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. JAMA. Retrieved from http://archinte.jamanetwork.com/article.aspx?articleid=2451282
    Boudin, M. (2015, February 25). Devastating side effects prompt local push to ban antibiotic. WCNC. Retrieved from http://www.wcnc.com/story/news/health/2015/02/24/devastating-side-effects-prompt-local-push-to-ban-antibiotic/23977183/
    FDA. (2008, July 8). Information for Healthcare Professionals: Fluoroquinolone Antimicrobial Drugs [ciprofloxacin (marketed as Cipro and generic ciprofloxacin), ciprofloxacin extended-release (marketed as Cipro XR and Proquin XR), gemifloxacin (marketed as Factive), levofloxacin (marketed as Levaquin), moxifloxacin (marketed as Avelox), norfloxacin (marketed as Noroxin), and ofloxacin (marketed as Floxin)]. Retrieved from http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm
    FDA. (2013, August 15). FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm
    Grossman v. Johnson & Johnson, et al. (2014, August 6). Complaint for damages and demand for jury trial. United States District Court Northern District Of California San Francisco Division. Case No. 3:14-cv-03557. Retrieved from http://www.pacer.gov
    Kellerman v. Bayer, et al. (2014, August 14). Complaint for damages and demand for jury trial. United States District Court Northern District Of California San Francisco Division. Case No. 3:14-cv-03680. Retrieved from http://www.pacer.gov
    Creative Commons. (n.d.). Levaquin. https://pillbox.nlm.nih.gov/assets/large/50458-0925-50_741B3A59.jpg
    U.S. Judicial Panel on Multidistrict Litigation. (2015, August 17). Transfer Order. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2642-Initial_Transfer-07-15.pdf
    U.S. Judicial Panel on Multidistrict Litigation. (2018, November 15). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-November-15-2018.pdf

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The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC)

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


https://web.archive.org/web/20190403024206/https://www.ema.europa.eu/en/news/fluoroquinolone-quinolone-antibiotics-prac-recommends-new-restrictions-use-following-review

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https://web.archive.org/web/20181116214529/http://www.pharmtech.com/ema-suspends-authorizations-quinolone-and-fluoroquinolone-antibiotics



EMA Suspends Authorizations of Quinolone and Fluoroquinolone Antibiotics
After a review of serious side effects, the agency decided to suspend marketing authorizations for quinolone and fluoroquinolone antibiotics and restrict use of remaining fluoroquinolone antibiotics.
Nov 16, 2018
By Pharmaceutical Technology Editors




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https://web.archive.org/web/20181012131059/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3194830/




FDA proposes to ban fluoroquinolones in poultry

April 1, 2004

Dr. Attila Molnar, President and CEO
Bayer Corporation
100 Bayer Road
Pittsburgh, PA 15205-9741

Dear Dr. Molnar:

The undersigned organizations strongly urge you to comply immediately the Food and Drug Administration’s proposal to ban Baytril, a fluoroquinolone antibiotic used in poultry. Such a decision would accord with the recent determination by an Administrative Law Judge that FDA’s proposed ban of Baytril is supported by a “substantial body of evidence” Decision of March 16, 2004, p. 64).

The Judge’s opinion makes clear that the decision to ban Baytril is not even remotely a close call. In addition to concluding that substantial evidence links use of Baytril in poultry to increased fluoroquinolone resistance in Campylobacter, the Judge determined that the credibility of one of Bayer’s key witnesses was so “severely compromised” that “his testimony cannot be relied upon” in light of his repeated mis-quotation of the scientific literature in his sworn testimony (p. 15). The Judge also characterized this same witness as using “faulty” and “unsubstantiated” methods (p. 62) and found that some of Bayer’s arguments were “not relevant” (p. 32), while others were “inconsistent” (p. 63). Bayer has already dragged this proceeding out for three and a half years following FDA’s October 2000 proposal.

The Judge’s 68-page decision is based on a formal evidentiary record that included 388 bound volumes containing more than 1,100 documents, and on cross-examination of experts lasting for more than a week. Enough is enough.

Though not a focus of the Judge’s decision, it is also worth noting that several major poultry corporations in the US have stated they are no longer using fluoroquinolones to produce chicken for human consumption. Similarly, many leading food-service companies – including McDonald’s, Dairy Queen, Burger King, Domino’s, Hardee’s, Wendy’s, Popeye’s, Subway, and BonAppetit – have stated that they do not purchase chicken raised with these drugs. In addition, pending legislation would ban the national school lunch program from serving chicken that was produced with the use of fluoroquinolones.

While FDA regulations provide Bayer with a 60-day period in which to appeal the ruling to the FDA Commissioner, we strongly encourage Bayer not to do so, and instead to comply immediately with the Judge’s decision that Baytril should be withdrawn from the market. Bayer is now the only manufacturer of fluoroquinolones for poultry, as the only other manufacturer of fluoroquinolones for poultry (Abbott Laboratories) voluntarily stopped marketing its version of the product when FDA first moved to ban it.

Baytril is virtually identical to Cipro, which is a key drug in treating severe food-borne illness in humans such as that caused by Campylobacter – particularly in people with weakened immune systems, such as cancer patients, transplant recipients, and persons with HIV/AIDS. In light of Bayer’s motto, “Expertise with Responsibility,” the responsible action now is to discontinue the manufacture of Cipro-like drugs for poultry without further procedural delays.



https://web.archive.org/web/20190419204357/https://www.pccmarkets.com/statements/md_bayer_040104/





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     Veterinary Pharmacology Antibacterial Agents

Quinolones, including Fluoroquinolones

By Dawn Merton Boothe, DVM, PhD, Professor, Department of Anatomy, Physiology, and Pharmacology, College of Veterinary Medicine, Auburn University

Quinolone carboxylic acid derivatives are synthetic antimicrobial agents. Nalidixic acid and its congener oxolinic acid have been used for treatment of urinary tract infections for years, whereas flumequine has been used successfully in several countries to control intestinal infections in livestock. Many broad-spectrum antimicrobial agents have been produced by modification of the various 4-quinolone ring structures.


https://web.archive.org/web/20180225220731/http://www.merckvetmanual.com/pharmacology/antibacterial-agents/quinolones,-including-fluoroquinolones



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