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FDA Announces Safety Labeling Changes for Fluoroquinolones
Thursday, May 12, 2016
[5-12-16] Today, the FDA is requiring labeling changes for antibacterial drugs called fluoroquinolones, including an updated boxed warning, stating that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that fluoroquinolones are associated with disabling and potentially permanent, serious side effects that can occur together. These side effect can involve the tendons, muscles, joints, nerves and central nervous system. As a result, the FDA is also requiring label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.
The FDA takes seriously its responsibility to protect the health of the American public through the review of safety, effectiveness and quality of medical products for patients. The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of fluoroquinolones and will keep health care providers and the public informed of new information.
Thursday, May 12, 2016
FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together.
Example letter to fluoroquinolone application holder (PDF - 50 KB) Because there are differences in the fluoroquinolones labels, FDA is posting an example sponsor letter that best captures the breadth of the announced safety labeling changes.
FDA Response to Citizen Petition: Southern Network on Adverse Reactions (SONAR), Docket No. FDA-2014-P-0856. The Petition requests that FDA require changes in the professional labeling of Levaquin (levofloxacin) regarding “Potential Mitochondrial Toxicity.”
Karen’s Journal was part of the evidence used that lead to that decision as we documented in the Nov 5th, 2015 entry. It took many people years to reach this point. To all of them, “Thank You.”
http://www.kpaddock.com/fq for easier to type URL.
Sadly, the FDA rejected the petition on “Potential Mitochondrial Toxicity.” Such toxicity may be confused with other diseases such as Fibromyalgia or Chronic Fatigue syndrome.
Note that the reaction to these antibiotics may be delayed, six months is common and was the case for Karen.
[In Decembr 2017, Janssen/J&J stopped producing Levaquin. Sadly, the generics are still being made.]
The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections [UTI] who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.
One lady stated that, given the choice between taking these FQ’s drugs that devastated her health and taking her chances with Anthrax, which is what these drugs are really for, she would take her chances with the Anthrax, even knowing some types of Anthrax have a death rate as high as sixty percent.
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