On February 16, 2006, the manufacturer of gatifloxacin announced that the drug’s label would change. According to a Food and Drug Administration (FDA) press release, “Since the approval
of gatifloxacin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug."

The New England Journal of Medicine has recently published two articles regarding the adverse reactions associated with gatifloxacin:

The first being "Outpatient Gatifloxacin Therapy and Dysglycemia in Older Adults" written by:
Laura Y. Park-Wyllie, Pharm.D., David N. Juurlink, M.D., Ph.D.,
Alexander Kopp, B.A., Baiju R. Shah, M.D., Ph.D., Therese A. Stukel, Ph.D., Carmine Stumpo, Pharm.D., Linda Dresser, Pharm.D., Donald E. Low, M.D., and Muhammad M. Mamdani, Pharm.D., M.P.H.

Click on the following link to download the first PDF File "Outpatient Gatifloxacin Therapy and Dysglycemia in Older Adults"

Click on the following link to download the second PDF File  "Serious Adverse Drug Effects — Seeing the Trees through the Forest" by Jerry H. Gurwitz, M.D. which is an editorial written in response to the first article mentioned above.

David Jurrlink, M.D., one of the original authors of "Outpatient Gatifloxacin Therapy and Dysglycemia in Older Adults" stated "Speaking as a clinician, I would NEVER prescribe this drug."

 Sidney Wolfe of Public Citizen stated "This represents a unique danger in the absence of a unique benefit...This is more than enough reason to think about petitioning the Food and Drug Administration to BAN this drug, and we probably will."

As early as 10-21-2001 the FDA requested label changes regarding this reaction, as well as numerous other adverse events.  Click on the following link to read the letter sent by the FDA to Bristol Myers-Squibb Company regarding these issues:

These supplemental new drug applications provide for the following changes to the Tequin® label. The deleted text is noted by strikethrough and the added text is noted by double underline as follows: 1. CLINICAL PHARMACOLGY • In the Glucose Homeostasis subsection, the first paragraph was revised to read: