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Product: Levaquin®(levofloxacin) and other fluoroquinolones
Company: Johnson & Johnson, et others
Petition Filer: State of Illinois
Petition Number(s): 2005P-0205 (renumbered 2005P-0064)
Date of Petition: May 24, 2005
Responding Petitions:Issue and Implication: Whether the fluoroquinolones antibiotics will need to add boxed warning labels concerning an increased risk of tendon tears and tendonopathy.
Action Requested by Petitioner: The Attorney General for the State of Illinois is asking FDA to require warning labels that state the increase risk of tendon issues and problems.
Summary of Petition(s): The Attorney General claims that many of its citizens are suffering from tendon tears, tendonitis and other diseases of the tendons which are brought on due to taking fluoroquinolone antibiotics, and in particular Levaquin. The atty General also submitted an amendment August 29, 2006 which is not available for review.
FDA Action: On July 28, 2008, FDA issued its response. For the most part, it granted the request, requiring the addition of boxed warnings and enhanced labels. However, it refused to require manufacturers to send “Dear Health Care Professional” Letters.
Citizen Petition
FDA Interim Response
FDA ActionProduct: Levaquin(levofloxacin) and other fluoroquinolone
Company: Johnson & Johnson et others
Petition Filer: Public Citizen
Petition Number(s): 2006P-0371 (renumbered 2006P-0390)
Date of Petition: September 8, 2006
Responding Petitions:Issue and Implication: Whether these products cause unnecessary tendon ruptures and whether these products should carry a “black box” warning in their labels.
Action Requested by Petitioner: Public Citizen requests the addition of “black box” warnings in their labels.
Summary of Petition(s): Public Citizen restates the argument made the State of Illinois (see above). It supports its request by stating that it has researched the FDA Adverse Events database which suggests that tendon ruptures are present in patients taking these products.
FDA Action: On July 28, 2008, FDA issued its response. For the most part, it granted the request, requiring the addition of boxed warnings and enhanced labels. However, it refused to require manufacturers to send “Dear Health Care Professional” Letters.
Product: Levaquin®(levofloxacin)
Company: Janssen
Petition Filer: Southern Network of Adverse Reactions (SONAR)
Petition Number(s): 2014P-0856
Date of Petition: July 17, 2014
Responding Petitions:Issue and Implication: Whether current FDA standards ensure safe use of medications.
Action Requested by Petitioner: The Petitioner is requesting that FDA add certain precautions and a black box warning to levofloxacin regarding possible mitochondrial toxicity.
Summary of Petition(s): SONAR makes a brief statement and request that levofloxacin be required to add certain precautions, dear doctor letters, and a black box warning regarding possible mitochondrial toxicity. SONAR supports its argument by pointing to recent FDA literature from April 2013 describing the increased toxicity of fluoroquinolones.
On May 22, 2015, FDA posted three items from meetings it held regarding this petition including meeting minutes and a presentation. These items were either redacted or unavailable for review.
FDA Action: On May 12, 2016, FDA denied this petition.
Product: Levaquin®(levofloxacin)
Company: Janssen
Petition Filer: Southern Network of Adverse Reactions (SONAR)
Petition Number(s): 2014P-1611
Date of Petition: October 15, 2014
Responding Petitions:Issue and Implication: Whether current FDA standards ensure safe use of medications.
Action Requested by Petitioner: The Petitioner is requesting that FDA add certain precautions, warnings, and a black box warning to levofloxacin regarding psychiatric side effects such as anxiety, agitation, and feeling abnormal.
Summary of Petition(s): SONAR makes a brief statement and request that levofloxacin be required to add certain precautions, special warnings, and a black box warning regarding possible psychiatric side effects. The box warning should include a statement about serious side effects and possibilities of suicide, toxic psychosis, etc. SONAR supports its argument by pointing to recent FDA literature and studies regarding adverse events and patients’ reactions to levofloxacin and other fluoroquinolones.
FDA Action: On July 11, 2018, FDA agreed to change the label to enhance and change the safety information but denied the specific requests of petitioner.
Product: Levaquin®(levofloxacin) in Dextrose 5% in Plastic Container
Company: Baxter
Petition Filer: Janssen
Petition Number(s): 2016P-1547
Date of Petition: June 14, 2016
Responding Petitions:Issue and Implication: Whether a product can be designated as a second reference list drug when the RLD has been withdrawn from the market.
Action Requested by Petitioner: The Petitioner is requesting that levofloxacin in dextrose 5% (A090343) be approved as a second reference list drug.
Summary of Petition(s): Petitioner notes that the original RLD (Levaquin – NDA (NO20635) has been withdrawn from the market. Of course, this leaves this product with a few approved generics. Petitioner would like to make this product and asks that the ANDA product from Dobfar be the second RLD. Petitioner also notes that two other ANDA approved products also reference this product including the market leader Sagent.
FDA Action: On December 5, 2016, FDA granted this petition.
Product: Levaquin®(levofloxacin)
Company: Janssen
Petition Filer: Southern Network of Adverse Reactions (SONAR)
Petition Number(s): 2019P-2998
Date of Petition: June 21, 2019
Responding Petitions:Issue and Implication: Whether current FDA standards ensure safe use of medications.
Action Requested by Petitioner: The Petitioner is requesting that FDA add certain precautions, warnings, and a black box warning to levofloxacin regarding neurological and psychiatric side effects. In addition to the boxed warning, it also asks for a REMS procedure for prescribers.
Summary of Petition(s): SONAR asks FDA to add boxed warnings for two things. First, it asks that the warning cover Fluoroquinolone-Associated Disability (FQAD) which covers a wide variety of adverse events for neurological disorders among other organ functions. Second, it also asks for a psychiatric adverse event boxed warning which covers several adverse reactions, including suicide. The Petitioner simply claims that the science and studies over the last decades demonstrate that these adverse events are significant in number and depth meriting boxed warnings. Moreover, it also asks for a REMS policy to ensure that physicians are properly trained about the risks.
FDA Action: On August 28, 2020, FDA denied this petition.
Product: Levaquin®(levofloxacin) and other fluoroquinolones
Company: Johnson & Johnson, et others
Petition Filer: Linda Martin, et al
Petition Number(s): 2023P-04222
Date of Petition: September 28, 2023
Responding Petitions:Issue and Implication: Whether the fluoroquinolones antibiotics will need to add boxed warning labels concerning an increased risk of tendon tears and tendonopathy.
Action Requested by Petitioner: The Petitioner is asking FDA to strengthen warning labels (boxed warnings) that state the increase risk of tendon issues and problems.
Summary of Petition(s): This petition is similar to the others previously filed on this issue.
FDA Action: Pending
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Gregory Glass
FDA Petitions
