The Fluoroquinolone Toxicity Research Foundation

 

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Cumulative marketshare of fluoroquinolones from January 1, 2001, through November 30, 2001, based on a sample of 3,356,872 prescriptions. During the time period between January 2001 and November 2001, the market for the fluoroquinolone class of antibiotics has been dominated by two products, (1) Cipro (ciprofloxacin) and (2) Levaquin (levofloxacin). These two products accounted for nearly 80% of all fluoroquinolone prescriptions. Cipro and Levaquin were followed by Tequin (gatifloxacin), with 12% of prescriptions, Avelox (moxifloxacin), with 7%, and Floxin (ofloxacin) and Noroxin (norfloxacin), each with 1%. Other fluroquinolones, namely Zagam (sparfloxacin), Trovan (trovafloxacin), Penetrex (enoxacin), and Maxaquin (lomefloxacin), accounted for less than 1% of all prescriptions dispensed.

Cumulative marketshare based on specific medical conditions as a percentage of total volume from January through October 2001, based on a sample of 55,053 prescriptions. Among patients diagnosed with a urinary tract infection, 64% had a prescription filled with Cipro. This was followed by Levaquin, with 28%, Tequin, with 4%, Floxin, with 2%, and Noroxin and Avelox, each with 1%. In patients with pneumonia, 62% received a prescription for Levaquin, followed by Tequin, with 17%, Cipro, with 13%, and Avelox, with 8%.

Proportion of utilization of fluoroquinolones based on patient gender, January through October 2001, based on a sample of 276,067 prescriptions. Utilization of each fluoroquinolone differs significantly by gender (P < .001, Z statistic), with women accounting for the majority of prescriptions for each product. The largest gender gap was seen with Noroxin, with 85% of prescriptions for women and 15% for men. Noroxin was followed by Cipro (71% vs. 29%), Zagam (69% vs. 31%), Floxin (67% vs. 33%), Tequin and Avelox (both 66% vs. 34%), and Levaquin (65% vs. 35%).

Trends in physician prescribing of fluoroquinolones by specialty from January through November 2001, based on a sample of 127,036 prescriptions. Among obstetricians/gynecologists, 72% of fluoroquinolone prescriptions were filled with Cipro, followed by Levaquin (16%), Floxin (8%), Tequin (3%), and Avelox (1%). Among urologists, Cipro accounted for 52% of fluoroquinolone prescriptions dispensed. Levaquin accounted for 35% of all fluoroquinolones prescribed by general practitioners, whereas those specializing in internal medicine prescribed Levaquin 42% of the time.

Note: All P-values are for Mantel-Haenszel x² test.


Tequin(r) (Gatifloxacin) Reaches 1 Million New U.S. Prescriptions
Tequin, Bristol-Myers Squibb's Quinolone Antibiotic, Continues to
Outpace First-Year New Rxs of Levaquin(r) (levofloxacin)

PRINCETON, NEW JERSEY (November 28, 2000) -- Bristol-Myers Squibb
Company (NYSE:BMY) announced that Tequin, a quinolone antibiotic,
reached the one million new prescription mark in the United States in
its first ten months on the market. Approved by the U.S. Food and
Drug Administration on December 17, 1999, Tequin is the only
quinolone antibiotic to achieve this milestone during the first 10
months on the market, according to audited data (October, 2000) from
IMS Ltd. Previously, the 10-month new prescription record for
quinolones was held by Levaquin(r) (levofloxacin, Ortho-McNeil).

"As we head into the respiratory tract infection season, Bristol-
Myers Squibb is pleased that physicians continue to recognize the
clinical efficacy and safety of Tequin," said Richard J. Lane,
president, Worldwide Medicines Group, Bristol-Myers Squibb. "This
outstanding growth, coupled with the recent release of impressive
clinical data from our TeqCES study of over 15,000 patients taking
Tequin, indicates that physicians have a high degree of confidence in
the ability of Tequin to effectively and safely treat indicated
respiratory tract infections due to susceptible strains of bacteria."

Bristol-Myers Squibb also noted that Tequin (gatifloxacin) new
prescriptions continue to climb as the respiratory season gets under
way. Moreover, physicians are prescribing at more than twice the rate
of Avelox(r) (moxifloxacin, Bayer), a quinolone antibiotic that was
released for marketing in December 1999 according to IMS Ltd.

"I believe that this demonstrates the increasing confidence
physicians have in prescribing Tequin," said Mark Gotfried, MD.,
adjunct associate professor, University of Illinois. "I think this
confidence can be attributed to Tequin's excellent safety,
tolerability and convenient once-daily dosing."

Since March 2000, Bristol-Myers Squibb and Schering-Plough
Corporation, a leading developer and marketer of respiratory
products, have been co-marketing Tequin in the United States. The
combined resources of both companies create excellent synergies for
the promotion of Tequin.

Tequin is used for indicated community-acquired respiratory tract
infections and is dosed 400 mg daily for these indications. Dosage
adjustments are required in patients with impaired renal function
(creatinine clearance, less than 40mL/min). The availability of
Tequin in bioequivalent 400 mg oral and IV formulations facilitates
transition for patients who begin treatment in the hospital and
continue on oral therapy at home. Tequin is primarily excreted
through the kidneys and less than one percent is metabolized by the
liver. In a clinical study (n=48), Tequin demonstrated a lower
potential for producing delayed photosensitivity skin reactions than
ciprofloxacin or lomefloxacin, and was comparable to placebo in
causing these same reactions.

Tequin may have the potential to prolong the QTc interval of the
electrocardiogram in some patients, and, due to limited clinical
experience, Tequin should be avoided in patients with known
prolongation of the QTc interval, patients with uncorrected
hypokalemia and patients receiving Class IA (e.g., quinidine,
procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic
agents. Tequin should be used with caution when given together with
drugs that may prolong the QTc interval (e.g., cisapride,
erythromycin, antipsychotics, tricyclic antidepressants), and in
patients with ongoing proarrhythmic conditions (e.g., clinically
significant bradycardia or acute myocardial ischemia).

The safety and efficacy of Tequin in children, adolescents (under
18), pregnant women and nursing mothers have not been established.
Tequin is contraindicated in persons with a history of
hypersensitivity to gatifloxacin or any member of the quinolone class
of antimicrobial agents. As with other quinolones, Tequin should be
used with caution in patients with known or suspected central nervous
system disorders or patients who have a predisposition to seizures.

The most common side effects associated with Tequin in clinical
trials were gastrointestinal. Adverse reactions considered to be drug
related and occurring in greater than or equal to three percent of
patients were: nausea (8 percent), vaginitis (6 percent), diarrhea (4
percent), headache (3 percent) and dizziness (3 percent).

Oral doses of Tequin (gatifloxacin) should be administered at least
four hours before the administration of ferrous sulfate, dietary
supplements containing zinc, magnesium, or iron (such as
multivitamins), aluminum/magnesium containing antacids or Videx(r)
(didanosine). Concomitant administration of Tequin and probenecid
significantly increases systemic exposure to Tequin. Concomitant
administration of Tequin and digoxin did not produce significant
alteration of the pharmacokinetics of Tequin; however, patients
taking digoxin should be monitored for signs and/or symptoms of
digoxin toxicity.

Tequin (gatifloxacin) was licensed by Bristol-Myers Squibb from
Kyorin Pharmaceutical Company Ltd. in September 1996, for development
and marketing in the U.S., Argentina, Australia, Brazil, Canada,
Mexico and certain other countries.

Bristol-Myers Squibb is a $20 billion diversified, global health and
personal care company whose mission is to extend and enhance human
life.

Levaquin(r) (levofloxacin) is a product of Ortho-McNeil Pharmaceutical.
Avelox(r) (moxifloxacin) is a product of Bayer Pharmaceuticals.


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