FDA: Tequin Was Withdrawn From U.S. Market "For Reasons Of Safety Or Effectiveness"

Recall That Bristol-Myers Had Said Decline In Sales Was Reason For Its Decision To Stop Selling Tequin

(Posted by Tom Lamb at DrugInjuryWatch.com)

On September 2, 2008 the FDA issued a Notice entitled "Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness" which provides (and confirms) the real reason that Bristol-Myers Squibb Co. (BMY) decided to pull Tequin from the U.S. market in the spring of 2006:

SUMMARY: The Food and Drug Administration (FDA) has determined that TEQUIN (gatifloxacin) Tablets, Injection, and Oral Suspension, were withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not accept or approve abbreviated new drug applications (ANDAs) for gatifloxacin oral tablets, injection, or oral suspension that refer to any previously approved dosage forms and strengths of TEQUIN (gatifloxacin).

As you may recall, in April 2006 when the news first broke that Bristol-Myers had decided to stop selling Tequin -- an antibiotic which was increasingly associated with potentially fatal blood-sugar problems -- the drug company said a continuing decline in Tequin sales was its reason for deciding to stop selling Tequin.

In turn, on May 1, 2006 the consumer advocacy group Public Citizen submitted a petition asking the FDA to ban Tequin in order to have this unsafe drug removed from pharmacy shelves immediately, as opposed to the gradual withdrawal announced by Bristol-Myers.

Now, more than two years after the Public Citizen petition about Tequin was submitted, we have the FDA's final word on the real reason that Tequin was taken off the market:

After considering the citizen petition and reviewing agency records concerning the drug product, analyses of AERS reports, and relevant literature, FDA has determined under Sec.  314.161 that TEQUIN was withdrawn from sale for reasons of safety or effectiveness.

This FDA determination seems to confirm earlier suspicions that, by going the course of a gradual withdrawal as opposed to a Tequin recall, BMS -- as it did with the now withdrawn anti-depressant Serzone -- was trying not to draw any additional attention to (or "hide" one might say) Tequin's safety problems. 

So much for candor from Big Pharma.

P.S.  For an in-depth review of various other issues concerning Tequin, you should read Armand Rossetti's September 11, 2008 post "The Tequin Mystery".  (9/11/08)