Bristol-Myers Squibb Hangs No Sale Sign on Tequin

By Peggy Peck, Managing Editor, MedPage Today
May 02, 2006
Also covered by: ABC News, CBS News, Forbes, Washington Post

NEW YORK, May 2 — Bristol-Myers Squibb will no longer manufacture or sell Tequin (gatafloxacin), an antibiotic that has been linked to both hyperglycemia and hypoglycemia in diabetics and elderly patients.


The company is not, however, pulling Tequin from pharmacy shelves. A company spokesperson urged patients taking Tequin to consult their physicians before stopping the drug.


The company disclosed its plans during a conference call with investors to discuss the company's annual report.


A spokesman for Bristol-Myers Squibb said that the company will return rights to the drug to Kyorin Pharmaceutical Company in Japan.


The Bristol-Myers Squibb action coincided with a petition by Public Citizen Health Research Group, the watchdog group, to the FDA to ban the drug, which it said was linked to 20 deaths and 159 hospitalizations since 2000.


Tequin was approved in 1999 and marketed for treatment of chronic bronchitis, sinusitis, pneumonia, and urinary tract infections.


In February, the FDA issued an alert concerning Tequin and strengthened the warning label on the drug. Also in February, Bristol-Myers Squibb sent a "Dear Doctor" letter warning that the drug was contraindicated for diabetic patients and reported increased risks observed among elderly patients and patients with renal insufficiency using Tequin.


A study reported in the March 2 issue of the New England Journal of Medicine found that patients in their 70s treated with Tequin were four times more likely to develop hypoglycemia and 17 times more likely to be hospitalized for hyperglycemia than similar patients treated with Biaxin (clarithromycin) or Zithromax (azithromycin).