BMS licensed the drug from Kyorin Pharmaceutical of Japan in 1996 and obtained FDA approval sell the drug in the US in December 1999.
A much more believable explanation for pulling Tequin off the market is that BMS is anticipating the filing of an infinite number of lawsuits against the company in the near future so it figured it was a good idea to get out of Dodge.
Tequin, (Gatifloxacin) belongs to the class of antibiotics known as fluoroquinolones, typically used to treat lung, sinus and urinary tract infections and certain sexually transmitted diseases.
This class of drugs has a long history of serious side effects. In fact, the following fluoroquinolones are either under use restriction, or have been removed from the market: (1) temafloxacin due to red blood cell damage, kidney failure and hypoglycemia; (2) grepafloxacin because of heart problems; and (3) trovafloxacin due to liver damage.
If BMS is to be believed, it was not aware of any serious side effects associated with Tequin when it was approved for use in the US. In a September 20, 2000 press release, the company announced that in the first 6 months, Tequin had been prescribed for more than 500,000 patients in the US within 6 months after it was approved by the FDA on December 17, 1999.
It bragged that Tequin was the first quinolone antibiotic to achieve this milestone during the first 6 months on the market, citing audited data reported in June, 2000, by IMS Health, a supplier of market research to the pharmaceutical industry
By September 2000, the press release said, Tequin had been prescribed to more than 800,000 patients in the US and more than 1 million patients worldwide.
And as a result, company profits skyrocketed. According to Bristol's 2004 Annual Report, In 2003, sales of Tequin increased by 13% to $208 million, up from $184 million in 2002.
In September 20, press release, BMS said the most common side effects associated with Tequin in clinical trials were gastrointestinal and adverse reactions "considered to be drug related and occurring in greater than or equal to three percent were: nausea (8%), vaginitis (6%), diarrhea (4%), headache (3%) and dizziness (3%)."
In a January 28, 2000, press release, the company said Tequin "has been shown in clinical trials to provide excellent efficacy and tolerability."
Not a peep was heard about the serious adverse reaction that have since been revealed.
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.
By 2002, Health Canada's database of spontaneous reports of adverse reactions indicated that hypoglycemia and hyperglycemia had been reported more frequently with gatifloxacin than with any other quinolone antibiotics, according to Parilo MA. Gatifloxacin-associated hypoglycemia, J Pharm Technol 2002;18:319-20.