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FDA Timeline
۰ February 15, 2006 – Bristol Myers Squibb changes Tequin labeling
۰ May 1, 2006 – Bristol Myers Squibb announced it will cease making Tequin
On February 15, 2006 Bristol Myers Squibb (BMS), revised Tequin labeling because it caused some people to have serious blood sugar problems (low blood sugar or high blood sugar).
The new Tequin label stated that Tequin should not be prescribed for patients with diabetes; that stronger warnings were needed regarding serious blood sugar problems; and that healthcare professionals should monitor patients who may be at risk of getting serious Tequin blood sugar problems. Additional risk factors such as older age patients and kidney problem were also noted as well as taking other medications that may cause Tequin adverse reactions.
Information about the risks of low blood sugar and high blood sugar were originally added to the WARNINGS section of the United States labeling in 2002, nearly three years after Tequin was approved by the FDA. The February 2006 label changes strengthen the existing WARNING on hypoglycemia and hyperglycemia and also include information identifying additional risk factors for developing low/high blood sugar, such as age and the effects of taking other medications with Tequin.
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On May 2, 2006, the watchdog consumer group, the Public Citizen petitioned the FDA to ban the antibiotic Tequin because it is linked to blood sugar abnormalities and has caused numerous deaths and hospitalizations.
Bristol-Myers Squibb withdrawing the drug but thousands of doses remains in the supply chain. Tequin is used to treat chronic bronchitis, acute sinusitis, pneumonia, urinary tract infection, and gonorrhea. In 2005, 1.2 million Tequin prescriptions were filled.
According to Public Citizen's analysis of adverse events reported to the FDA, 388 patients had dangerously low or high blood sugar as a result of taking Tequin between Jan. 1, 2000 and June 30, 2005. From those, 20 people died and 159 were hospitalized.
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Changes made to the label to warn patients about Tequin dangers were insufficient.
More than half a dozen other antibiotics exist to treat similar conditions and all are safer than Tequin.
