Tequin News

Bristol-Myers Squibb Co. ceased the manufacture and sale of Tequin (Gatifloxacin) April 27, 2006. While Tequin is effective against a variety of infections, the risks of its use outweigh its benefits. Many complications and some deaths relate to Tequin use.

Tequin is a member of the fluoroquinolone family of antibiotics, which includes the popular drug, Cipro. Fluoroquinolones are synthetic (man made) broad-spectrum antibiotics that are especially effective against many species of bacteria. Drug manufacturers developed fluoroqinolone antibiotics as a response to increasing antibacterial resistance of some bacteria.

Fluoroquinolones carry the risk of serious side effects. Some fluoroquinolone antibiotics are no longer available due to their health risks. Glaxo Wellcome discontinued Raxar in 1999, due to negative cardiovascular effects. In 1992, Abbott Laboratories released and then quickly discontinued production of Omniflox following reports of serious reactions including three deaths. Trovan, a Pfizer product, is no longer available due to liver toxicity. Even the popular antibiotic Cipro, a Bayer product, carries the risks of psychosis and achilles tendon rupture.

Cipro remains on the market, because the medical community feels that its benefits outweigh its risks. According to the U.S. Food and Drug Administration • Center for Drug Evaluation and Research, Cipro is a drug of choice for treatment of inhalational anthrax exposure. "If a person is exposed to [anthrax], the risk of adverse events caused by Cipro (ciprofloxacin hydrochloride) therapy may be acceptable because of the severity of this disease."

Clinically, physicians prescribed Tequin for a variety of community acquired infections. One of the most common uses of Tequin was to treat acute exacerbations of chronic bronchitis. The American Lung Association defines chronic bronchitis, a form of chronic obstructive pulmonary disease (COPD), as "the presence of a mucus-producing cough most days of the month, three months of a year for two successive years without other underlying disease to explain the cough." Inflammation and scarring causes the cough, and may lead to decreased airflow and infection. Tequin is effective against this pulmonary infection.

Community acquired pneumonia (CAP) is pneumonia contracted outside of the hospital or nursing home environment. Pneumonia is a common ailment effecting about 4 million Americans per year. CAP may spread to the blood causing bacteremia, the ear causing otitis media, and the brain and spinal chord causing meningitis. Tequin is effective against the acute bacterial infections of CAP.

Acute sinusitis is another common airway infection that physicians treated with Tequin. Sinusitis may present as a toothache, head cold or runny nose with colored discharge. The variety of symptoms and slow onset sometimes makes sinusitis difficult to diagnose. Antihistamines and decongestants usually provide a cure; the most intransigent cases receive antibiotic treatment.

Physicians prescribe Tequin for treatment of gonorrheal infections of the urethra, cervix and rectum. While the CDC recommends other antibiotics for treatment of gonorrhea, one of the recommended antibiotics is Cipro, a closely related member of the Fluoroquinolone family of antibiotics.

Tequin is useful in the treatment of urinary tract infections (UTI), including pyelonephritis (kidney infection) due to the bacteria, E. coli.

Tequin is very effective against skin lesions involving the organism Staph aureus. Many medications have a long list of side effects or adverse reactions. Many of Tequin's gastrointestinal side effects are common among antibiotics such as nausea, diarrhea, vomiting, abdominal pain, headache, and indigestion.

Another of Tequin's side effects, common to many medications, is photosensitivity. Some medications increase skin sensitivity to the sun. Increasing photosensitivity may increase the likelihood of sunburn, or cause skin eruptions such as hives, blisters, and eczema like rashes. Photoreactive drugs may initiate or worsen autoimmune disease such as lupus erythematosis and rheumatoid arthritis in which the body's own defenses damage otherwise healthy cells.6 Medications that may cause photosensitivity are Ibuprofen (Motrin, Advil), Accutane, Benadryl, Crestor, Hydrochlorathiazide, Lasix, Levitra, and over one hundred and fifty other prescription and non-prescription medications.

Tequin use carries the risk of psychiatric side effects. Patients report episodes of anxiety, agitation, confusion and insomnia. Reports of such symptoms are common to the fluoroquinolone family of antibiotics. Patients who are prone to seizures should not take Tequin or other fluoroquinolones unless necessary. Psychosis, the extreme impairment of the ability to think clearly, may be another side effect.

Increased intracranial pressure (pressure on the brain) or pseudotumour cerebri is a very serious side effect of Tequin. Patients may present to an eye care professional complaining of double vision. Other symptoms include headache and nausea. Physicians and optometrists can diagnose increased intracranial by a routine examination of the optic nerves. These patients should go to a hospital emergency room for immediate treatment. The treatment of choice may be removal of cerebrospinal fluid. In a study of a dozen patients treated for increased intracranial pressure caused by the antibiotic minocycline, 25% suffered some permanent vision loss.

Vaginitis, infection of the vagina, is a common side effect of antibiotic use. Antibiotics kill off some of the bacteria that normally inhabit the vagina such as Lactobacillus, allowing pathogenic (disease causing) organisms to flourish. Overgrowth of Candida albicans or yeast causes a yeast infection with a characteristic odor and white discharge. Overgrowth of Trichomonas vaginalis causes Trichomonas infection. Increasing the population of pathogenic bacteria such as E. coli may result in a case of bacterial vaginosis (BV). Rarely, bacterial vaginosis can cause pelvic inflammatory disease (PID). PID can cause infertility by damaging the fallopian tubes that deliver the egg from the ovary to the uterus.

Doctors gauge the health of the liver by ordering liver function tests (also known as LFT's or a liver panel). Fluoroquinolones including Tequin commonly raise LFT levels. Ordering this routine blood test allows early detection and complete recovery of liver damage.

Pseudomembranous colitis is an uncommon, severe infection of the colon associated with many antibiotics especially fluoroquinolones. Antibiotics kill off beneficial bacteria and allow Clostridium difficile to proliferate. The resulting infection causes diarrhea, fever and abdominal pain. Treatment usually is limited to cessation of the antibiotic. In some cases, administration of antibiotics metronidazole or vancomycin is the treatment of choice to clear the Clostridium infection. Rarely, pseudomembranous colitis results in death.

Oddly, fluoroquinolones including Tequin may have musculoskeletal effects. There is a rare, but well-known risk of muscle and ligament rupture especially involving the Achilles tendon. Joint stiffness is another side effect. Animal studies reveal damage to weight bearing joints with Tequin use. Patients who experience joint, muscle or tendon pain should stop taking Tequin or other fluoroquinolones and report the symptom to their physician.

Another unusual effect of fluoroquinolones involves changes to the heartbeat. Patients may feel a cardiac arrhythmia as a skipped beat or palpitation. Cardiac symptoms are another reason to stop taking this medication and contact the prescribing physician.

The most serious side effect of Tequin appears to be its effect on glucose or blood sugar. Tequin may cause hyperglycemia or hypoglycemia. According to a petition by the Health Resource Group (HRG) submitted to the FDA on May 1, 2006, Tequin use was the proximate cause of over 150 hospitalizations and 20 deaths due to dysglycemia (abnormal level of glucose that is high or low). The petition requests the immediate ban of Tequin from the U. S. market.

Bristol-Myers Squibb Co. and others circulated warnings of the effect Tequin has on blood sugar. The warnings first centered on elderly patients9 and those with diabetes. On May 1, 2006, Bristol-Myers Squibb announced that they will no longer produce or market Tequin, and that they will return rights to the drug to Kyorin Pharmaceutical Company in Japan. Bristol-Myers Squibb advises people to continue to take Tequin until they consult their physician.