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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 [2019/12/25 00:40] bpaddock Added ruptures or tears in the aorta blood vessel FDA warning. | ||
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- | The News Net5 [[http://media.newsnet5.com/uploads/FDA%20Levaquin%20Study.pdf? | + | The News Net5 {{ : |
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+ | 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: | ||
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+ | {{ : | ||
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+ | </ | ||
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+ | ---- | ||
+ | <WRAP warning> | ||
+ | ====== FDA warns about increased risk of ruptures or tears in the aorta blood vessel ====== | ||
+ | FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients | ||
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+ | < | ||
+ | Safety Announcement | ||
+ | [12-20-2018] A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. | ||
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+ | Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available. | ||
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+ | Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years. | ||
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+ | Health care professionals should avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, | ||
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+ | Patients should seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back. Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately. | ||
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+ | We reviewed cases reported to FDA* and four published observational studies1, | ||
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+ | We communicated safety information associated with fluoroquinolones in July 2018 (significant decreases in blood sugar and certain mental health side effects), July 2016 (disabling side effects of the tendons, muscles, joints, nerves, and central nervous system), May 2016 (restricting use for certain uncomplicated infections), | ||
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+ | To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving fluoroquinolones or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page. | ||
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+ | *The cases were reported to the FDA Adverse Event Reporting System (FAERS). | ||
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+ | </ | ||
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+ | ### | ||
+ | Release: | ||
+ | ### ---- https://www.fda.gov/drugs/drug-safety-and-availability/ | ||
+ | </ | ||
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+ | <WRAP warning> | ||
+ | ====== | ||
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+ | < | ||
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+ | For Immediate Release July 10,2018 | ||
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+ | 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, | ||
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+ | “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. | ||
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+ | 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. | ||
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+ | 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, | ||
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+ | Additionally, | ||
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+ | Today, the FDA also published a [[https:// | ||
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+ | 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). | ||
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+ | In 2016, the FDA [[https:// | ||
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+ | 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. | ||
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+ | The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, | ||
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+ | </ | ||
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+ | 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, | ||
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+ | ### | ||
+ | Release: | ||
+ | ### -- https:// | ||
+ | </ | ||
</ | </ | ||
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For Immediate Release July 26, 2016 | For Immediate Release July 26, 2016 | ||
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Release: | Release: | ||
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</ | </ | ||
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+ | <WRAP important> | ||
+ | ====== European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics ====== | ||
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+ | November 16 2018: | ||
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+ | < | ||
+ | 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// | ||
+ | // | ||
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+ | October 5th 2018: | ||
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+ | < | ||
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+ | Press release 05/10/2018 [October 5th 2018] | ||
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+ | 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. | ||
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+ | 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. | ||
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+ | < | ||
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+ | The PRAC recommended that the remaining fluoroquinolone antibiotics should: | ||
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+ | **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. | ||
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+ | 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).</ | ||
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+ | June 13th 2018: | ||
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+ | [[https:// | ||
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+ | {{youtube> | ||
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+ | </ | ||
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<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: | ||
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+ | ---- | ||
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+ | [[https:// | ||
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+ | < | ||
+ | In layman' | ||
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+ | This is not well known by the medical community and is in part why irreversible damage from fluoroquinolone antibiotics is not well understood. | ||
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+ | Long answer: Fluoroquinolones are definitely chemotherapy drugs, and they' | ||
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+ | ---- | ||
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===== Dear Doctor ===== | ===== Dear Doctor ===== |