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Studies link tequin to hyper- and hypoglycemia.(Clinical Rounds)
Results from two large studies of patients aged 66 and older show a strong association between the use of gatifloxacin and inpatient treatment for both hypoglycemia and hyperglycemia. The findings follow close on the heels of the drug's fourth label change, which was based on case reports that suggested the drug can dramatically alter blood glucose levels.
Patients treated on an inpatient basis for hyperglycemia were almost 17 times (OR 16.7) more likely to have been recently treated with gatifloxacin than with a macrolide antibiotic, said Laura Y. ParkWyllie, of the Institute of Clinical Evaluative Sciences in Toronto, and her colleagues. Patients treated on an inpatient basis for hypoglycemia were four times (OR 4.3) more likely to have been recently treated with gatifloxacin than with a macrolide (N. Engl. J. Med. [Epub ahead of print], February 2006, DOI:10.1056/NEJMoa055191).
In February, Bristol-Myers Squibb, which markets gatifloxacin under the trade name Tequin, revised prescribing information to include a contraindication in diabetic patients. (See previous page.)
"The study is consistent with what we did with the label change ... and the issuance of the 'Dear Healthcare Provider' letter, in that [use of gatifloxacin] is contraindicated in certain populations, particularly those who are diabetic," BMS spokesman Eric Miller said in an interview.
The researchers used health care records for more than 1.4 million Ontario residents aged 66 years or older to identify (study 1) patients who received hospital care for hypoglycemia within 30 days after outpatient antibiotic therapy or (study 2) patients who received hospital care for hyperglycemia within 30 days after outpatient antibiotic therapy between April 2002 and March 2004.
Antibiotics included macrolides, oral second-generation cephalosporins, or respiratory fluoroquinolones. Macrolides were used as the reference group in all analyses because these antibiotics and fluoro-quinolones are prescribed for similar community-acquired infections but macrolides do not directly influence glycemic control.
A total of 788 patients received hospital care for hypoglycemia within 30 days of antibiotic therapy, of which 46% ...
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Source: HighBeam Research, Studies link tequin to hyper- and hypoglycemia.(Clinical Rounds)