Tequin FDA Information
FDA approved Tequin, to be used as a quinolone antibiotic in the year 1999. This drug was approved to be used to treat bacterial infections, in specific, causing a variety of health problems. Hence Tequin was unfit to treat diseases due to viral infections.
On 15th February 2006, Bristol Myers Squibb announced an update to the U.S. labeling for Tequin tablets and injections. The update was in the form of a Dear Healthcare Professional Letter (DHCP) that was issued to the U.S. physicians. It stated the labeling changes that were to be made:
- To strengthen the “already existing Warning” on hypoglycemia and hyperglycemia.
- Add a CONTRADICTION for use in diabetic patients. It was observed that people of both the category, with or without diabetes, reported hyperglycemia and hypoglycemia. These events can occur at any point during the course of the medication.
- Identify the risk factors that can lead to development of low or high blood sugar like age, renal problems and concomitant glucose-altering medications, while using Tequin.
The warning in the DHCP letter also mentioned that the blood sugar levels should be closely monitored during the course of this medication, especially in the high risk population, and if symptoms of either hyperglycemia or hypoglycemia are found, then Tequin should be stopped immediately and replaced with an appropriate therapy.
In April 2006, BMY, i.e. Bristol- Myers, decided to withdraw the medicine from the market owing to a continual decline in the sales of Tequin. Ralph Nader, who founded a public interest group called Public Citizen, made references to 388 patients who used Tequin and suffered from blood irregularities. The sample of these 388 patients included 20 deaths and 159 hospitalizations since January 2000. So, on 1st May, based on these references, Mr. Ralph Nader filed a petition with FDA and demanded a total drug recall instantly, which was opposed by BMY, as they had planned a gradual recall.
FDA then considered
- The citizen petition
- Agency records on Tequin
- Analysis of AERS reports and
- All other relevant literature to reach to the final conclusion.
On 2nd September 2008, FDA issued a notice entitled “Determination that Tequin (gatifloxacin) was withdrawn from sale for reasons of safety or effectiveness”. This notice cleared the fact that BMY pulled the drug off the market in the spring of 2006 due to lapses in the health security and not owing to the dip in sales. The notice was as mentioned below:
This FDA determination cleared out the airs surrounding BMY gradual withdrawal of Tequin. By going in for a gradual recall of the drug, the manufacturers wanted to avoid any additional attention that the medicine would have got, thereby avoiding any claims or compensations.