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On Dec. 21, 2005, the Canadian equivalent of the Food and Drug Administration (FDA), Health Canada, warned the public and healthcare professionals of serious cases of both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia) with the use of the fluoroquinolone antibiotic gatifloxacin (TEQUIN).
The Canadian warning is based on study conducted on over 15,000 patients after the drug was approved.
High blood sugar occurred in 0.007 percent of patients without diabetes and in 1.3 percent of those with the disease. The incidence of low blood sugar was 0.03 percent in nondiabetic patients and 0.64 percent in patients with diabetes. The total incidence of serious high and low blood sugar adverse reactions was 0.03 percent.
Although these are small percentages, given the fact that there were almost 1.7 million prescriptions dispensed in U.S. pharmacies in 2004 for gatifloxacin, many patients are likely to be affected.
The Canadian authorities warned that some of the blood sugar reactions were life-threatening, resulting in death in some cases. If gatifloxacin is prescribed for diabetic patients, blood sugar should be closely monitored, especially during the first three days of treatment with the drug. If the signs or symptoms of low or high blood sugar listed below develop in any patient taking gatifloxacin, usually between the fourth and tenth days of treatment, appropriate medical treatment must be given and the gatifloxacin stopped. Immediately notify of your physician so that an alternative antibiotic can be prescribed.
Signs Of Low Blood Sugar:
- anxiety
- blurred vision
- cold sweats or cool, pale skin
- confusion
- difficulty concentrating
- drowsiness
- increased hunger
- headache
- nausea
- nervousness
- nightmares and restless sleep
- rapid heartbeat
- shakiness
- slurred speech
- unsteady walk
- abnormal tiredness or weakness
- behavior change similar to drunkenness
- weight gain
Signs Of High Blood Sugar:
- blurred vision
- drowsiness
- dry, flushed skin
- breath smells of fruit
- increased urination
- loss of appetite
- tiredness
- abnormal thirst
- deep, rapid breathing
- dizziness
- dry mouth
- headache
- stomachache
- nausea and/or vomiting
FDA warnings about disturbances in blood sugar levels are similar to the Canadian warnings, except that the new Canadian warnings are based on much larger studies than the FDA warnings.
Gatifloxacin was approved by the FDA in December 1999. It became the ninth fluoroquinolone antibiotic on the market in the United States. We listed it as a DO NOT USE drug in the July 2002 issue of Worst Pills, Best Pills News because it can cause a dangerous abnormality in the heart’s electrical conduction known as QT prolongation. QT prolongation can lead to fatal heart rhythm disturbances.
Public Citizen petitioned the FDA in 1996 to require a tendinitis and tendon rupture warning in the professional product labeling of all fluoroquinolone antibiotics, and as a result all these drugs now carry the warning. See the box for more information.
What You Can Do
There is no medical reason to take gatifloxacin. There are numerous other, safer antibiotics that are approved by the FDA to treat the same infections as this drug.
