Problem-plagued antibiotic to come off the market
Tuesday, May 02, 2006

WASHINGTON - An antibiotic plagued by serious blood-sugar complications is coming off the market.

Bristol-Myers Squibb Co. confirmed Monday that it plans to stop making and selling Tequin.

Spokesman Eric Miller said the company will return rights to the drug to Kyorin Pharmaceutical Company in Japan. He said the company acted after a commercial evaluation of the product as well as ongoing transition in the company's focus.

Approved for sale in 1999, Tequin has faced questions about its effects on blood sugar, being associated with both high- and low-blood sugar in some patients.

In February, the Food and Drug Administration required increased warnings on the drug's 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.

Miller said that while Bristol-Myers Squibb will stop making and selling the drug, stocks currently available are not being recalled. He urged people using Tequin not to discontinue it until they talk with their physician about an alternative.

A public interest group, meanwhile, petitioned the FDA on Monday 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.

Public Citizen urged the FDA to order a recall of the drug.

"This drug carries unique risk but has no unique benefits and therefore should not be on the market," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

Tequin is prescribed for chronic bronchitis, sinusitis, pneumonia, urinary tract and other infections.

Tequin had $150 million in global sales last year including $100 million in the U.S.

On the Net:

FDA: www.fda.gov

Bristol-Myers Squibb: www.bms.com

Public Citizen: www.citizen.org

From the Tuesday, May 02, 2006 edition of the Augusta Chronicle
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