FDA To Hold Upcoming Meeting on Fluoroquinolones
A few days ago the FDA notified us that two FDA committees, the Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) and Drug Safety and Risk Management Advisory Committee, will be holding a joint meeting on November 5th, 2015 regarding the Fluoroquinolones. The committees will discuss the risks and benefits of the systemic Fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.
Even though the agenda of the joint meeting involves the discussions within the scope for the above named conditions, we will be submitting requests to speak, including discussion points, and coordinating individuals, including professionals, to speak on behalf of the Fluoroquinolone community at the FDA advisory meeting.
We believe that the attention given the Fluoroquinolones through the combined media stories, past rallies, citizen petitions, in addition to community members meeting directly with FDA officials, provided some of the impetus, in part, for the scrutiny of the Fluoroquinolones being prescribed for these common health conditions. More information about this meeting will be forthcoming when available. Stayed tuned to My Quin story for timely updates on our interactions with the FDA, Dr. Bennett and the Citizen Petition, and community related research.