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FDA Asked to Ban Antibiotic Tequin

May 2, 2006 | Consumer Affairs

Public Citizen has petitioned the U.S. Food and Drug Administration (FDA) to ban the antibiotic Tequin because it is linked to blood sugar abnormalities and has caused deaths and hospitalizations.

The drug, made by Bristol-Myers Squibb and approved for use in the United States in December 1999, has been linked to severe cases of low blood sugar and high blood sugar. The company is withdrawing the drug but thousands of doses remain in the supply chain.

The drug is used to treat chronic bronchitis, acute sinusitis, pneumonia, urinary tract infection and gonorrhea. In 2005, 1.2 million prescriptions for the drug 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. Of those, 20 people died and 159 were hospitalized.

Changes made to the label to warn patients about the dangers of the drugs are insufficient, said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

More than half a dozen other antibiotics exist to treat these conditions and all are safer than Tequin.

Bristol-Myers Squibb's quiet announcement last Friday that it would no longer manufacture Tequin for economic reasons is similarly inadequate to protect the public's health since the company apparently has no intention, absent FDA action to ban the drug, to stop selling the large amount of Tequin already in the channels of commerce. Thus, without an FDA ban, thousands of additional patients will be prescribed this unacceptably dangerous drug, Wolfe said.

In addition to the adverse events associated with Tequin that were reported to the FDA, a study published on March 1 in The New England Journal of Medicine showed that patients receiving Tequin had approximately 17 times the odds of having dangerously high blood sugar and four times the odds of having dangerously low blood sugar compared to those taking other antibiotics.

In addition, such blood sugar abnormalities have been noted in clinical trials, post-marketing surveillance studies, case reports and other studies.

"This drug carries unique risk but has no unique benefits and therefore should not be on the market," Wolfe said.

If Tequin is banned, it will be the fifth drug of 13 approved quinolone antibiotics to be taken off the market because of serious safety problems.


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