Tequin Revisited: Health Canada And The FDA Failed To Take Action, At Our Expense

Bristol-Myers Squibb Was Allowed To Withdraw Their Unsafe Drug For "Economic Reasons", And Only After Selling Off Its Inventory

(Posted by Tom Lamb at DrugInjuryWatch.com)

An article by Joel Lexchin, MSc MD, "Information about a discontinued drug", published in the March 11, 2008 edition of the Canadian Medical Association Journal (CMAJ), reminded me about how Health Canada and the FDA failed to order a recall of Tequin (gatifloxacin) a couple of years back.  Instead, Bristol-Myers Squibb (BMS) was allowed to do a gradual withdrawal of Tequin and, in so doing, the drug company largely succeeded in not drawing any additional attention to Tequin's safety problems.

In the spring of 2006, Bristol-Myer said that a continuing decline in Tequin sales was the reason for deciding to stop selling Tequin.  In fact, however, Tequin was an unsafe drug that had been linked to various blood-sugar disorders -- but the FDA as well as Health Canada let the drug company have it their way.

For the following review of developments and events leading up to how BMS ended its Tequin sales in the U.S. and Canada, I draw from two of my earlier reports about this dangerous antibiotic:   

• Bristol-Myers Squibb To Stop Selling Antibiotic Drug Tequin
• Antibiotic Tequin Should Be Banned By FDA, Says Public Citizen Petition

Mid-February 2006: BMS, the FDA, and Health Canada announced that the Tequin label would be changed to include stronger warnings about the threat of life-threatening events from blood-sugar changes.

March 1, 2006: The New England Journal of Medicine (NEJM) published online an early-release version of a study which found that patients using Tequin had four times the risk of hypoglycemia (low blood sugar) and an astounding 17 times the risk of hyperglycemia (high blood sugar) -- collectively referred to as dysglycemia -- when compared to other antibiotics.

April 27, 2006:  A newspaper article is the first announcement that BMS has decided to stop selling Tequin.  According to this Wall Street Journal article, however, Tequin product shipments would not end in most markets until sometime in May or June 2006.

May 1, 2006: Public Citizen asked the FDA to ban Tequin in order to immediately get this unsafe drug off pharmacy shelves in the U.S.  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 and hyperglycemia; 20 on those reports involved patient deaths.

To my knowledge, the FDA never banned Tequin in the U.S. as requested by Public Citizen.

The March 2008 CMAJ article which is mentioned at the outset of this piece confirms that Health Canada did nothing:

Health Canada issued a number of alerts about the potential for this product to interfere with glucose metabolism but never bothered to formally inform either the public or health care professionals that oral and intravenous forms of this drug were withdrawn from sale in Canada. The only place where one can find this information is by searching the discontinued products in Health Canada's Drug Product Database (http://cpe0013211b4c6d-cm0014e88ee7a4.cpe.net.cable.rogers.com/dpdonline/searchRequest.do). This failure to communicate important information about a drug raises serious concerns about Health Canada's ability to keep health care professionals and the public informed about safety issues.

I believe the same thing -- "raises serious concerns" -- can be said about how the FDA let the drug company Bristol-Myers Squibb seemingly sell-off its inventory of Tequin instead of the FDA ordering an immediate recall of Tequin. 

In the end, this history of Tequin appears to be a prime example of putting profits over public safety.

Comments

[Tom Lamb]

I greatly appreciate you letting us know about this online petition for our readers to consider and sign.

I agree with you about MedWatch being relatively unknown among patients -- as well as some healthcare providers, I suspect -- and agree that if TV drug ads told consumers where to report side effects this would be one way to improve the MedWatch program.

If others have ideas about how to make the MedWatch program work better in terms of getting more adverse drug events reported to the FDA, please share your thoughts with us here.

Thanks for reading Drug Injury Watch.

Tom Lamb

[blake]

The FDA’s current system for consumers to report drug side effects, called Medwatch, is woefully inadequate and has been estimated to collect only 1 to 10 percent of all adverse events – because consumers don’t know about it!

Last year, Congress passed legislation requiring all printed drug ads to include Medwatch’s 1-800 number and website information, but left it to the FDA to determine if such information should also be included in TV ads. Their recommendation is due in March: it’s time to let the FDA know that we are serious about better reporting and giving consumers this potentially life-saving information. Take action at www.PrescriptionForChange.org! Sign the petition and tell the FDA that TV drug ads should tell consumers where to report side effects.