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Updated Label Includes Risk of Hypoglycemic Coma
July 10, 2018 - The FDA once again updated the warning label of fluoroquinolone antibiotics. According to the update, the drugs may increase the risk of significant blood sugar levels and certain mental health side effects.
Fluoroquinolones are a very strong form of antibiotics commonly used to stop the growth of bacterial infections. Fluoroquinolones are the most commonly used form of antibiotics, taken by nearly 33 million consumers in the U.S. annually. The product contains fluoride, a neurotoxin, which can enter the brain and central nervous system through sensitive tissues.
Fluoroquinolones were first approved to treat a small number of bacterial infections, primarily urinary tract infections. The antibiotics are now used to treat a wide range of bacterial infections.
Fluoroquinolones are often used when a patient has built up an immunity to other antibiotics, prompting the use of this very strong class of drugs. Most often, fluoroquinolones antibiotics are used to treat the most severe bacterial infections.
Fluoroquinolones have been linked to serious adverse health effects, including tendon problems and permanent nerve damage. As a result, the FDA has mandated that all fluoroquinolone drugs carry a black-box label warning consumers of the risks associated with the antibiotics.
Common fluoroquinolones include:
Levaquin was first approved for marketing in 1996. It accounts for around 28% of all fluoroquinolone prescriptions in the U.S., making it the second most popular fluoroquinolone antibiotic. It was previously the most prescribed antibiotic in 2010, used to treat a range of bacterial infections including urinary tract infections, respiratory infections, bronchitis, pneumonia, and even plague.
According to the FDA, a new warning is needed for Levaquin, Cipro, Avelox and other fluoroquinolones (FQs) as they may trigger a serious, persistent, multi-symptom disability referred to as fluoroquinolones-associated disability (FQAD). FQAD refers to a “constellation of symptoms” leading to disability that has been observed during FDA monitoring of FQ safety reports.
Although most of the individual symptoms observed are documented in the literature and reflected in the FQ drug medication guides, there have been no warnings in the past about a link to a constellation of symptoms across organ systems.
Case Studies seem to indicate that individuals experience FQAD symptoms differently. However, a diagnosis of this disability requires the following:
Case studies note that while some symptoms may appear during the FQ course of treatment, it is not unusual for some individuals to present symptoms linked to FQAD appearing months after treatment has stopped. In addition, some symptoms progressively worsen over time.
The FDA has received more than 50,000 reports of adverse events and 2,600 reports of deaths associated with Levaquin, Cipro, Avelox, and Factive, through June 30, 2015. According to FDA estimates only about ten percent of all adverse events are actually reported to the FDA, as these are voluntary reports. Furthermore, in the case of FQAD, most consumers and many doctors were not aware that there could be a link between a delayed symptom and an FQAD course of treatment. Therefore, it is possible that the number of adverse events that were actually related to FQ treatments is more than ten times as large as currently reported.
For years, activists and researchers have been trying to get the word out to the public about the risks that these popular billion-dollar drugs carry with them. Many critics have been public about their belief that FQs, including Levaquin, Cipro, Avelox and Factive (as well as the six other FQs that were removed from the market) are over-prescribed and they should be reserved for conditions in which other effective antibiotics are not available.
The FDA has discovered links between fluoroquinolone antibiotics and a number of adverse, disabling and potentially irreversible health risks, including:
The side effects can include tendon damage or rupture, permanent nerve damage in the extremities, liver toxicity, kidney failure, hearing or vision problems, or psychiatric side effects. Many of these symptoms can be irreversible.
Because of the dangerous health risks involved with fluoroquinolones, the FDA recommends that for some more common bacterial infections fluoroquinolones only be used if no other options are viable.
TorHoerman Law is pursuing fluoroquinolone lawsuits cases for patients who are/were prescribed Levaquin products and suffered the following injuries:
The fluoroquinolone lawsuits against manufacturer Levaquin claims that patients suffered aortic dissection / aortic aneurysm that resulted in hospitalization, surgery, or death within one year after taking the antibiotics. The fluoroquinolone lawsuit further claims that the manufacturer failed to warn patients of the potential for these injuries.
Studies suggest that individuals who are prescribed fluoroquinolone are two times as likely to develop these dangerous aortic conditions.
The fluoroquinolone lawsuit claims that manufacturer of Levaquin:
Currently, the fluoroquinolone lawsuit has not reached class action status. The number of individual cases continues to grow.
You may qualify to participate in a fluoroquinolone lawsuit if you meet the following conditions
To help determine whether you or a loved one qualifies to participate in a fluoroquinolone lawsuit, contact the offices of TorHoerman Law today for a free, no-obligation fluoroquinolone lawsuit case consultation.
May 12, 2016 - A drug safety communication was issued advising that fluoroquinolones should only be used for patients when there are no other options available due to the dangerous side effects associated with the class of drugs.
November 2015 - The FDA met to discuss the risks and benefits of using fluoroquinolone antibiotics on patients suffering from bronchitis, sinusitis, and urinary tract infections. The FDA cited adverse event reporting from patients outlining a series of symptoms referred to as Fluoroquinolone-Associated Disability, or FQAD.
FDA review panel members voted that the benefits, as well as the risks of fluoroquinolone antibacterial drugs, support the need for a label change. After reviewing the panel's findings, the FDA is expected to decide whether or not a black box warning or other safety communication should be added to the labels of drugs like Cipro and Levaquin.
July 2008 - A black box warning was added to fluoroquinolones for the increased risk of tendinitis and tendon rupture which was later updated in February 2011 to include the risk of worsening symptoms for those with myasthenia gravis.
The label was again updated in August 2013 to include the potential risk for irreversible peripheral neuropathy (serious nerve damage).
"Bitter Pill: Serious Side Effects of Fluoroquinolone Antibiotics." Mercola.com, 1 Nov. 2014, articles.mercola.com/sites/articles/archive/2014/11/01/fluoroquinolone-antibiotic-side-effects.aspx.
"FDA Drug Safety Communication: FDA Updates Warnings for Oral and Injectable Fluoroquinolone Antibiotics Due to Disabling Side Effects." Drug Safety Communications, www.fda.gov/downloads/Drugs/DrugSafety/UCM513019.pdf.
Kroll, David. "Yet Another Warning On Fluoroquinolone Antibiotic Side Effects." Forbes, Forbes Magazine, 1 Aug. 2016, www.forbes.com/sites/davidkroll/2016/07/31/yet-another-warning-on-fluoroquinolone-antibiotic-side-effects/#3796ac7c1d45.
"Press Announcements - FDA Updates Warnings for Fluoroquinolone Antibiotics." U.S. Food and Drug Administration Home Page, 26 July 2016, www.fda.gov/newsevents/newsroom/pressannouncements/ucm513183.htm.
Last Modified: May 8th, 2019 @ 02:11 pm
Fluoroquinolones are the most popular form of antibiotics, used to treat an array of bacterial infections. Despite their success in treating infections, fluoroquinolones have been linked to a number of serious, disabling, and potentially irreversible adverse health effects that the makers of the antibiotics fail to adequately warn consumers of. As a result, a fluoroquinolone lawsuit has been filed on behalf of individuals who have suffered injuries due to fluoroquinolone antibiotics.
TorHoerman Law is currently accepting fluoroquinolone lawsuit cases for Levaquin brand injuries, including an aortic aneurysm and aortic dissection.
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