Manufacturer: Bristol-Myers Squibb (BMS)
Date approved: 1999
Status: Withdrawn from market
Approved uses: Treatment of sinus and lung infections, some sexually transmitted diseases
Off-Label uses: N/A
• Serious cases of diabetes
• dangerous blood sugar levels
• abdominal pain
Related topics: Unsafe Drugs
Tequin (generic name gatifloxacin) is an antibiotic that inhibits bacterial enzymes that are common causes of respiratory illnesses and infections of the sinuses and urinary tract. Tequin is also used in the treatment of sexually transmitted diseases such as gonorrhea. Manufactured by Bristol Meyers Squibb, Tequin received a stringent “black box” label warning from the FDA after it was linked to side effects including dramatic blood sugar swings. In May 2006, Bristol Meyers Squibb announced that it had stopped manufacturing Tequin and would not sell Tequin in the United States after existing stockpiles were sold.
Tequin Linked to Severe Blood Sugar Swings; Manufacturer Ceases Production
In an alert issued in March 2006, the federal Food and Drug Administration (FDA) warned the public about a previously unknown side effect of the antibiotic Tequin: severe blood sugar problems in patients. Bristol Meyers Squibb, the drug’s manufacturer, revised its labeling in response to a growing number of cases of Tequin side effects that have arisen since the drug’s approval in 1999. However, Bristol Meyers Squibb reported in May 2006 that it would end sales after the drug’s existing stockpiles were sold, returning all rights for the drug from its originating company, Japan-based Kyorin Pharmaceuticals.
What is Tequin?
Tequin (generic name gatifloxacin) is an antibiotic that inhibits bacterial enzymes that are common causes of respiratory illnesses and infections of the sinuses and urinary tract. The drug, which is a member of the fluoroquinolone family of antibiotics, is also used in the treatment of sexually transmitted diseases such as gonorrhea; however, Tequin is not indicated in the treatment of syphilis or non-gonococcal sexually transmitted infections.
Tequin was approved for use in the United States in December 1999 and is commonly prescribed in patients suffering from respiratory infections. It is available in tablet and intravenous form and was initially linked to side effects such as photosensitivity (extreme skin sensitivity to sunlight) and associated skin rashes and sunburns, dizziness, and interactions with diuretics, vitamins containing iron or magnesium, and other drugs.
Blood Sugar Side Effects
The March 2006 label changed indicated additional Tequin side effects affecting blood sugar in patients. The drug was now counterindicated for patients suffering from diabetes and linked with extremely low and extremely high blood sugar in some patients. The drug’s new label also warned that certain risk factors might cause patients to experience Tequin blood sugar side effects. These include kidney problems, old age, and exposure to other drugs that affect blood sugar.
An analysis by Public Citizen, a consumer watchdog group, alleges 20 deaths and over 150 Tequin-related hospitalizations between January 1, 2000 and June 30, 2005. Symptoms indicated in Tequin side effects included hypo- and hyperglycemia, coma, stroke, and even death. The group’s analysis also pointed out that 46 percent of patients who experienced blood sugar side effects while taking Tequin were not diabetic, citing a 2006 study that indicated that non-diabetic patients taking Tequin were 13 percent more likely to experience a hyperglycemic (high blood sugar) episode than those taking other antibiotics.
Though Bristol Meyers Squibb announced it would be ceasing manufacture of the drug and that sales would cease when U.S. stockpiles had been depleted, the company made no attempt to remove the product from the market. Likewise, though it did require its most stringent “black box” warning on Tequin labels, the FDA has not pulled the drug from the market or taken further regulatory action.
If You’ve Experienced Tequin Side Effects
If you have suffered from Tequin blood sugar side effects such as the ones described above or other Tequin symptoms, you may be able to recover the costs of your medical care and lost wages by filing a Tequin lawsuit. After obtaining the proper medical care, contact a lawyer experienced in unsafe drugs litigation. Your Tequin attorney can tell you whether you have a claim and help you file suit. A Tequin lawyer may also help you obtain compensation for your side effects, which may include cash payments for pain and suffering, medications and current and future medical costs.