The Fluoroquinolone Toxicity Research Foundation

 
  You are visitor number Counter
Letters to the FDA and Congress    See downloads for: Adobe Files



DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Rockville MD 20857

March 12, 2004


This is in response to your emails to Dr. McClellan, Dr. Sherman, and Dr. Galson of
February and March, 2004 regarding Quinolone post marketing reports. They have
forwarded your emails to the Center for Drug Evaluation and Research's Office of
Executive Programs to respond.

We would like to thank you for your post marketing surveillance reports of January and February, 2004. However, CDER's Office of Pharmaceutical Science reviewed your initial submission for January and the numbers are not consistent with the reported numbers within our office. It was also noted that the majority of those adverse events reported are well-known side effects of the Fluoroquinolone class of drugs. Since approving the first Class of Fluoroquinolones in 1996 for treatment of acute maxillary sinusitis, acute bacterial exacerbations, of chronic bronchitis, community-acquired pneumonia, uncomplicated skin and skin structure infections, complicated urinary tract infections and acute pyelonephritis, there have been several labeling supplements added as well as adding new indications since the original approval in 1996. As you know, we will weigh all risks and benefits associated with Fluoroquinolone Class Drugs prior to taking any additional action.

We will continue to monitor future adverse events reported to us. We recommend that your organization encourage those individuals contacting you regarding adverse events experienced when taking Quinolone submit a MedWatch report at
http://www. fda. gov/medwatch.

If you would like to view FDA's reports on adverse events associated with Fluoroquinolones, please submit a Freedom of Information request. The following web address will provide instructions on how to submit your request:
http://www.fda.gov/opacom/backgrounders/foiahand.html

Additionally, you can contact the Office of Training and Communications, Division of Drug ~nformation at 88 8-INFO FDA (463-6332) for additional assistance. Again, thank you for submissions and interest in this issue.

Sincerely,

Frances T. Gipson, FACHE
Office of Executive Programs
Center for Drug Evaluation and Research