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Tequin Antibiotic Antibiotic class action

This case was issued in conjunction with Siskind, Cromarty, Ivey & Dowler LLP on May 8, 2006.

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March 2, 2006

Worth repeating from CBC Health & Science News:

The antibiotic Tequin can have life-threatening side-effects in people with diabetes, a study by Canadian researchers has found. The antibiotic gatifloxacin is sold under the brand name Tequin by its manufacturer, Bristol-Myers Squibb.

Health Canada is urging doctors to stop prescribing the antibiotic for patients with diabetes as a precaution. Tequin treats respiratory infections, urinary tract and bladder infections, and sexually transmitted diseases. People taking Tequin showed more than a four-fold increase in the risk of being treated in hospital for low blood sugar compared to people who were on an older class of antibiotics, the researchers found.

Others showed nearly 17 times more risk of developing high blood sugar. Both conditions can be fatal, although falling blood sugar levels can cause death quicker.

Muhammad Mamdani of the Institute for Clinical Evaluative Sciences in Toronto and his colleagues studied patients over 65 admitted to hospital in Ontario.

Risks were similar regardless of the presence or absence of diabetes, the team reported. Gatifloxacin belongs to a class of antibiotics called fluoroquinolones, the most prescribed antibiotics in North America. The low blood sugar side-effect didn't appear to apply to other fluoroquinolones, the study said.

Health Canada has asked for more safety data on the antibiotic to investigate its possible link to blood glucose disorders.

In the meantime, the regulator recommends people with diabetes should be prescribed alternative antibiotics.
People with diabetes who are taking Tequin should talk to their physician if they have any concerns, Health Canada advised.

Bristol-Myers Squibb also recommends doctors should keep a close eye on non-diabetic patients taking Tequin, especially if they are over 75, have kidney problems or are taking diabetes medications.

Mamdani's study was to be published in the New England Journal of Medicine later this month, but it was released early online because of the public health implications.

Advisory
2006-09
February 16, 2006
For immediate release

Health Canada advises diabetic patients not to use the antibiotic Tequin
OTTAWA - Health Canada is advising diabetic patients, as a precaution, not to use the antibiotic Tequin due to concerns about blood glucose disorders. This advice is based on recommendations submitted to the department by the manufacturer of the drug, Bristol-Myers Squibb.

Tequin is an antibiotic prescribed for the treatment of respiratory infections, urinary tract and bladder infections, and sexually transmitted diseases.

In December 2005, Health Canada asked the company to submit revised product information for Tequin, following evidence indicating a possible link between the antibiotic and blood glucose disorders. The company submitted this information and Health Canada is currently reviewing it. The public and health professionals will be informed of the results of the review once it is complete.
In the meantime, given the availability of other antibiotic medications, Health Canada recommends as a precaution that patients with diabetes be prescribed alternative therapies. Diabetic patients currently taking Tequin should contact their physicians if they have any concerns.

The manufacturer has also recommended that doctors who prescribe Tequin to non-diabetic patients take enhanced precautions and do close medical monitoring especially if those patients have certain risk factors, such as being 75 years of age or older, having kidney problems, or taking diabetes medications.

In December, the manufacturer, in consultation with Health Canada, issued a letter to health professionals and a public advisory about a possible link between the antibiotic and blood glucose disorders, after serious cases of both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia) were reported in patients worldwide. An article about glucose disorders associated with Tequin was issued by Health Canada in the Canadian Adverse Reaction Newsletter in July 2003.

December 19, 2005
Subject:
Association of the antibiotic TEQUIN* (gatifloxacin) with potentially serious high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia)
Bristol-Myers Squibb Canada, in collaboration with Health Canada, is informing healthcare professionals of important safety information regarding TEQUIN* (gatifloxacin). TEQUIN is an antibiotic used to treat certain lung, sinus, or urinary tract infections, and also to treat certain sexually transmitted diseases.
Please be aware of the following important safety information that may be relevant to patients receiving TEQUIN.
Cases of both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), that can sometimes be serious and life-threatening, have been reported in patients treated with TEQUIN. Low and high blood sugar can be reversible if recognized and treated.
Some, but not all, of these cases have been reported with TEQUIN in diabetic patients. Patients over 75 years of age with additional medical problems or taking additional medications may be at risk for high and/or low blood sugar.
Diabetics are at a higher risk of developing low blood sugar. However both low and, in particular, high blood sugar levels occurred in some patients with no known history of diabetes.
Patients who develop signs and symptoms of low or high blood sugar, as described by their physician, while on TEQUIN should stop taking TEQUIN and contact their healthcare professional at once.

Canadian Adverse Reaction Newsletter
Volume 13, Number 3, July 2003

The Canadian product monograph for Tequin™ was recently updated in response to reported cases of serious, and in some cases life-threatening, disturbances of glucose homeostasis.

Health Canada received 28 reports of abnormal glucose metabolism associated with gatifloxacin (44% of total reports received for the drug) from Feb. 21, 2001 (the date marketed in Canada), to Feb. 28, 2003: 19 were of hypoglycemia, 7 were of hyperglycemia and 2 were of both hypoglycemia and hyperglycemia. Twenty-five of the cases involved patients with type 2 diabetes (determined from the patient's history or use of concomitant medications), 2 involved nondiabetic patients, and in 1 case the diabetic status was unknown. The 28 cases were serious, and 19 of the patients were admitted to hospital or had a prolonged hospital stay because of the reaction. The 2 patients who died (86 and 102 years of age) had hyperglycemia, no prior history of diabetes and decreased renal function at the time of the reaction.

Concomitant use of hypoglycemic agents was noted in 18 of the 19 cases in which a hypoglycemic reaction was reported.

Summary of latest results

The New England Journal of Medicine (NEJM) rushed a study to its website regarding the frightening and harmful effects of the antibiotic Tequin (gatifloxacin).

Drugmaker Bristol-Myers already knew trouble was brewing last month when the FDA mandated a warning label advising doctors against prescribing Tequin -- one of a group of broad-spectrum antibiotics used to "cure" lung, sinus and urinary tract infections along with some sexually transmitted diseases -- to diabetics.

This latest and larger NEJM study found elderly patients above age 65 were an amazing 17 times more likely to have elevated blood sugar levels and four times more prone to have unusually low blood sugar levels, with both conditions requiring hospitalization. More than 1,200 Canadian seniors required medical attention and 69 patients died after taking Tequin over the course of the two-year study.

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