Tequin®
Manufacturer:
Bristol-Myers Squibb
Uses: Antibiotic
More Information
Tequin®, an antibiotic commonly used to treat adults with lung,
sinus and urinary tract infections as well as certain sexually transmitted
diseases, was officially pulled from the market by the FDA on May 1, 2006.
Tequin® was approved for sale by the FDA in 1999 and has faced
questions about its effects on blood sugar, being associated with both high and
low blood sugar in some patients.
This past February, the FDA required increased warnings on the drugs label.
The manufacturer has warned that it should not be used by diabetics and said the
elderly and those with kidney disease are more likely to have problems.
Manufacturer Bristol-Myers Squibb will stop making and selling the drug, but
stocks currently available are not being recalled. A Bristol-Myers Squibb
spokesperson urged people using Tequin® not to discontinue it until
they talk with their physician about an alternative treatment.
Before the drug was pulled, public interest group Public Citizen petitioned
the FDA for a ban on the antibiotic. In its petition, Public Citizen said there
have been 388 patients with blood-sugar irregularities associated with the drug
including 20 deaths and 159 hospitalizations since Jan. 1, 2000.
Tequin® is an antibiotic in the class of drugs called
fluoroquinolones, also containing Cipro, Levaquin and Avelox. This recent study
indicates that the risk of diabetes is specific to Tequin® and is not
a problem with the entire class of drugs.
On March 1, 2006 the results of a Canadian study were released which showed
that Tequin® was linked to serious cases of diabetes and other blood
sugar disorders. According to the study, Tequin® users had a 17 times
greater risk of developing serious diabetes and a 4 times greater risk of being
hospitalized with low blood sugar complications than patients using other
antibiotics. These results were set to appear in the March 30, 2006 New England
Journal of Medicine but were released early due to the life threatening nature
of these side effects. Based on the studys alarming findings, the author, Dr.
David Juurlink of the Sunnybrook and Womens College Health Sciences Center in
Toronto, questioned whether the drug should be immediately removed from the
market. Other prominent physicians believe that a black box warning should be
added immediately to the Tequin® warning label.
In early 2006, Bristol Myers Squibb and the FDA added a warning to the drugs
label notifying diabetics not to take Tequin®. However, the study
said the blood-sugar problem can happen to anybody whether they have diabetes or
not, and it usually occurs within a few days of taking the drug. The risk of the
drug might be even greater than the study revealed because it was only based on
hospital data. If a patient suffered these side effects but wasnt hospitalized,
or died, they would not have been included in the study data.
Side Effects
- Diabetes
- Other Deadly Blood Sugar Abnormalities
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