Antibiotic Tequin® To Be Taken Off the Market
NEW YORK, NY -- May 12, 2006 -- Bristol-Myers Squibb Co. will stop manufacturing the antibiotic, Tequin® (gatifloxacin), but plans to leave the current stock of the drug on the shelves until it is depleted. Approved in 1999, Tequin® is prescribed for bronchitis, pneumonia, gonorrhea, and lung, skin, kidney and urinary tract infections. However, Tequin® has caused severe blood glucose level changes in some patients, leading to hospitalizations and deaths.
The consumer group, Public Citizen, filed a petition last week asking the Food and Drug Administration (FDA) to immediately ban all Tequin® sales. Over a period of five and one-half years, 388 patients developed Tequin®-related low blood sugar, according to FDA statistics cited by Public Citizen (Letter to FDA, May 1, 2006). Twenty of the patients died from blood sugar abnormalities and 159 were hospitalized, the group said.
The FDA first added information about Tequin®'s effects on blood sugar levels to the drug's prescribing instructions in 2002. In February of this year, the FDA strengthened the language of the warning, and indicated that Tequin® should not be used by diabetics (FDA News, February 16, 2006). Other high risk groups include the elderly, patients taking medications that alter their glucose levels, and patients with kidney problems, the new instructions say.
Other Antibiotics Safer Than Tequin®, Study Shows
Several other antibiotics can treat the same conditions for which Tequin® is prescribed. "This drug [Tequin®] carries unique risk but has no unique benefits and therefore should not be on the market," commented Dr. Sidney Wolfe, director of Public Citizen's Health Research Group (Press Release, May 1, 2006).
A study of 1.4 million Canadians taking antibiotics over a two-year period found Tequin® users were almost 17 times more likely to have a high blood sugar (hyperglycemic) episode than were patients taking other antibiotics such as erythromycin (N Engl J Med. 2006 Mar 30; 354(13): 1352-61). They had four times the odds of having a low blood sugar (hypoglycemic) episode.
In 2005, Tequin® had $150 million in global sales, including $100 million in the United States, according to news reports. Clearly, Tequin® is a very profitable, but dangerous drug.
Have You Been Injured by Tequin®?
Brayton Purcell is currently evaluating medical and legal information about Tequin® side effects. If you or a family member has been treated with Tequin® and suffered severe episodes of high or low blood sugar, please contact us. We will review your potential case free of charge, and advise you of your legal rights. Our firm has been handling medically-related cases for over 20 years, including those involving unsafe or ineffective medications.