Tequin drugmaker named in class-action lawsuit

Updated Tue. May. 9 2006 6:30 AM ET

CTV.ca News Staff

A $200,000 class-action lawsuit has been launched against Bristol-Myers Squibb, alleging the drugmaker failed in its duty to warn patients of the risks associated with commonly prescribed antibiotic.

The lawsuit argues that the drugmaker failed to properly apprise one of the plaintiffs, Alban Conlon, as well as physicians in Canada of risks associated with Tequin.

The statement of claim filed Monday alleges that Conlon, 70, fell into a coma after taking three doses of the drug in March 2002 to treat bronchitis.

The suit also alleges that Conlon was hospitalized for seven months and that he will now require medical care for the rest of his life.

"It completely took my life away. My life has changed so badly It makes me cry. I fight tears a lot of times for that very reason," Conlon told CTV.

Indications there might be problems with Tequin first surfaced about three years ago. Some hospitals stopped using the drug then, but Tequin continued to be prescribed across Canada to about 500 patients per day.

The lawsuit alleges the drug should have been pulled from sale years ago, as the risks were known.

"To leave the drug on the market after there's significant information out there, to continue to sell it when there are plenty of alternative medications ... is, in our opinion, negligent," said Charles Wright, lawyer for the plaintiffs.

The biggest plaintiffs might well be provincial health plans that had to foot the bill for those Tequin patients who develop side effects and had to be treated by their doctors or hospital emergency wards.

"In each of those cases there was a cost to the health care system," Wright said.

Since the plaintiffs have just filed their statement of claim, the defendants -- filed by the defendants, Bristol-Myers Squibb Canada Co. and Bristol-Myers Squibb Company -- have not had time yet to file a statement of defence.

The drugmaker confirmed earlier this month that it plans to stop making and selling Tequin, known generically as gatifloxacin.

Bristol-Myers Squibb spokesman Eric Miller said the company will return rights to the drug to Japan's Kyorin Pharmaceutical Co., noting that the decision was made after a commercial evaluation of the product as well as an ongoing transition in the company's focus.

Meanwhile, Health Canada was also advised that Tequin will no longer be sold to Canadian pharmacies.

Study's findings

Two months ago, a Canadian study found that Tequin was linked to a fourfold increase in the risk of being treated in hospital for low blood sugar and an almost 17-times greater risk of developing high blood sugar.

While it's unusual for a drug to have two opposing effects, it's believed Tequin may interfere with regulation of insulin secretion from the pancreas, which controls blood sugar levels.

In contrast, no significant increased risk of low or high blood sugar levels was seen with any other drug from the same class of antibiotics.

Gatifloxacin is typically taken to treat patients with pneumonia, bronchitis, gonorrhea and other infections, such as those affecting the skin, urinary tract or kidneys.

According to the study, the risk of blood sugar abnormalities was not restricted to patients with diabetes.

The study of patients over age 65 between April 2002 and March 2004 was published in the New England Journal of Medicine.

Earlier this year, the U.S. Food and Drug Administration required increased warnings on the drug's label.

Health Canada also issued warnings about possible adverse effects for diabetics taking Tequin and had planned to further update safety information, including the possibility of a "black box" warning used when a drug is potentially lethal.