Antibiotic Tequin Should Be Banned By FDA, Says Public Citizen Petition

Tequin Ban Is Needed To Prevent Any Further Use Of This Unsafe Drug

On May 1, 2006 the consumer advocacy group Public Citizen asked the FDA to ban Tequin, an antibiotic made by Bristol-Myers Squibb Co. (BMS).  The FDA needs to ban Tequin, according to this Public Citizen petition, in order to immediately get this unsafe drug off pharmacy shelves in the U.S.

A week before Public Citizen requested that Tequin be banned, BMS announced that it planned to stop selling Tequin.  According to an April 27, 2006 article in the Wall Street Journal, however, Tequin product shipments would not end in most markets until sometime in May or June 2006.  Put otherwise, this would be a gradual withdrawal process by the drug company; there would not be any immediate recall of Tequin by Bristol-Myers.  This means, in effect, that Tequin could still be prescribed by doctors and taken by patients in the next couple of months -- a situation that Public Citizen finds unacceptable due to the serious side effects associated with Tequin.

According to the Public Citizen petition, an analysis of adverse event reports submitted to the FDA reveals that during the period January 1, 2000 through June 30, 2005 there were 388 cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) -- collectively referred to as dysglycemia; 20 on those reports involved patient deaths.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, alleges that changes made to the package insert, or label, for Tequin in February 2006 are insufficient.  Moreover, there are at least six other antibiotics available which, according to Public Citizen, are all safer than Tequin.  Therefore, Dr. Wolfe asserts, "This drug carries unique risk but has no unique benefits and therefore should not be on the market."

By going the course of a gradual withdrawal as opposed to a Tequin recall, it seems that BMS -- as it did with the now withdrawn anti-depressant Serzone -- is trying not to draw any additional attention to Tequin's safety problems.  Like it did when withdrawing Serzone from the market, BMS says that a continuing decline in Tequin sales is its reason for deciding to stop selling Tequin.

(Posted by: Tom Lamb)