ANTIBIOTIC TEQUIN (GATIFLOXACIN) LINKED TO BLOOD SUGAR ABNORMALITIES

May 4, 2006

On May 1st, 2006, Public Citizen filed a petition with the FDA asking for a complete ban on the prescription antibiotic gatifloxacin (TEQUIN) because of severe fluctuations in blood sugar caused by the drug. The petition followed a quiet announcement on Friday afternoon that Bristol Myers Squibb, the manufacturer of brand-name gatifloxacin, would no longer produce the drug. On Feb. 15, 2006, the company announced that the drug’s professional product label would be updated to include reports of serious blood sugar fluctuations, including some deaths.  Bristol-Myers-Squibb’s action is inadequate to protect the public’s health since they apparently have 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. In 2005, 1.2 million prescriptions were written for gatifloxacin. You can read Public Citizen’s petition on www.worstpills.org.

According to our analysis, there have been 388 patients with gatifloxacin-associated fluctuations in blood sugar, including 20 deaths and 159 hospitalizations, reported to the FDA from Jan. 1, 2000, through Jun. 30, 2005. The fourth label change on Feb. 15, 2006 was an insufficient remedial action for a drug that carries unique risk without unique clinical benefit compared to the seven other fluoroquinolones currently approved by the FDA and other drugs approved for similar indications. 

Gatifloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis, acute sinusitis, community-acquired pneumonia, uncomplicated urinary tract infection, complicated urinary tract infection, pyelonephritis, and uncomplicated urethral and cervical gonorrhea. Other drugs to treat these conditions do not have the risks of gatifloxacin. When this drug is banned, it will be the fifth drug out of 13 approved in this family of antibiotics to be taken off the market because of serious safety problems. The banned quinolone antibiotics are temafloxacin (OMNIFLOX), which caused low blood sugar, kidney failure, and a certain rare form of anemia; grepafloxacin (RAXAR) and sparfloxacin (ZAGAM), which caused QT-interval prolongation and increased risk of heart arrhythmias, and trovafloxacin (TROVAN) which caused liver toxicity.