Quinolones News

#1 October 17, 2008

Gatifloxacin (TEQUIN) was withdrawn from sale
The FDA issued a notice to determine that TEQUIN (gatifloxacin) Tablets, Injection, and Oral Suspension, were withdrawn from sale for reasons of safety or effectiveness.

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Gatifloxacin associated with an increased risk of hypoglycemia and hyperglycemia

A study published in “The New England Journal of Medicine” showed that patients receiving gatifloxacin had approximately 17 times the odds of having dangerously high blood sugar levels and 4 times the odds of having dangerously low blood sugar levels compared to those taking other antibiotics.

This is the latest in a long series of concerns that have been voiced about gatifloxacin. For example, in January 2003, the FDA received notice of revised product labeling in which references to gatifloxacin injection (10 mg/ml, 200 mg) were deleted indicating that this product was no longer being marketed for reasons of safety and effectiveness.

On May 1, 2006, Public Citizen Research Group submitted a citizen petition requesting that the FDA immediately ban TEQUIN because of the increased risk of producing high and low blood sugar levels. This was prompted by high numbers of reported gatifloxacin-associated adverse event.

In June 2006, the manufacturer of the drug announced that it would no longer market TEQUIN. The FDA has now determined that all previously approved TEQUIN products will be withdrawn for reasons of safety and TEQUIN will be removed from the list of drug products published in the Orange Book.

Source: N. Eng J Med. 2006 Mar 30; 354(13): 1352-61. Epub 2006 Mar 1. [PMID: 16510739]

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