Tequin

On May 1, 2006, Bristol-Myers Squibb Co. confirmed it will stop producing and distributing Tequin. The reason for the recall is due to the effects it has on blood sugar levels.

Reports indicate there have been 388 patients with blood-sugar irregularities associated with the drug, which include 20 deaths and 159 people hospitalized since Jan. 1, 2000.

If you are taking Tequin, it is recommended that you not stop taking the drug immediately, but rather should contact your doctor first.

Although Tequin is prescribed for chronic bronchitis, sinusitis, urinary tract and other infections, it has been shown to cause both high and low blood sugar levels.

Serious risks and possible side effects associated with Tequin may include, but are not limited to:

• Severe blood sugar changes including low-blood sugar (hypoglycemia) and high-blood sugar (hyperglycemia)
• Serious allergic reactions , which may be fatal; symptoms include trouble breathing, throat closure, inflammation of the lips, tongue, or face
• Central nervous system (CNS) side effects such as seizures, dizziness, tremors, confusion, depression, hallucinations, or suicidal thoughts
• Rupture of a tendon , which cause severe pain and inflammation
• Sever diarrhea, which may be fatal

More common Tequin side effects include: nausea, vomiting, stomach pain, diarrhea, and headaches.

FDA News
February 16, 2006

Stronger Warnings for Tequin

Today, Bristol-Myers Squibb Co. announced labeling changes for Tequin (gatifloxacin), an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys, and skin.

The labeling changes, announced by the Tequin manufacturer in a letter to healthcare professionals, update the prescription information as a result of continued reports of serious cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients receiving Tequin. Since the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug. Most of these events were reversible when properly managed, but a few had fatal outcomes.

Information about the risks of low blood sugar and high blood sugar was added to the WARNINGS section of the U.S. labeling in 2002. Today's changes strengthen the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), add a CONTRAINDICATION for use in diabetic patients, and include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose altering medications while taking Tequin.

The FDA will continue monitoring Tequin's safety to ensure that its benefits outweigh the risks to patients.