Poor Bristol-Myers Squibb has withdrawn its embattled antibiotic Tequin from sale, saying that the decision was taken after evaluating the commercial prospects for the drug.
The decision comes just as US consumer group Public Citizen petitioned the US Food and Drug Administration (FDA) to force Tequin (gatifloxacin) off the market, saying that the antibiotic's side effects meant that it should no longer remain on sale.
The petition said there have been 388 patients with blood-sugar irregularities associated with the drug including 20 deaths and 159 hospitalisations since the beginning of 2000. Tequin was approved in the USA in 1999 for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea and various infections including infections of urinary tract, kidneys and skin.
In February, the FDA slapped stronger warning labels on Tequin after continued reports of both low and high blood sugar levels in patients taking the drug, and contraindicated its use in diabetics. It also said care should be taken when administering the antibiotic to the elderly and those with reduced kidney function.
Go here for a great piece on the whole affair by Evelyn Pringle:
"However, BMS has been aware of most of Tequin's side effects for years. For instance, an article about the glucose disorders associated with the drug was published by Health Canada in the Canadian Adverse Reaction Newsletter in July 2003.
The article discussed a postmarketing study on the use of gatifloxacin with more than 15,000 patients and reported the incidence of hypoglycemic events as 0.3 per 1000 among nondiabetic patients and 6.4 per 1000 in patients who were diabetic.
The rate of hyperglycemia found in the study was 0.07 per 1000 in nondiabetics, and 13 per 1000 in diabetic patients."
Source: PharmaTimes
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