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02-Mar-01 - Debating Zyban's Safety - Role of Anti-Smoking Drug Being Probed In 24 Deaths

02-Mar-01 - Debating Zyban's Safety - Role of Anti-Smoking Drug Being Probed In 24 Deaths

Zyban is under investigation as a possible cause of at least four deaths in Canada, 18 in Britain and one in Australia.

The worldwide debate over the safety of Zyban, a top-selling medication that was launched in 1997 and is used by one million Canadians and 14 million people in the rest of the world, continues and many questions require answers.

GlaxoSmithKline, the British-based pharmaceutical giant that makes Zyban, denies any proven link so far between its drug and the fatalities. Investigators at Health Canada and other countries' health authorities agree. Bupropion hydrochloride, which has an anti-depressant effect, is an active ingredient in Zyban, which is also marketed to psychiatric patients under the brand name Wellbutrin.

The drug changes the balance of chemicals in the brain and reduces a craving for nicotine. A typical treatment lasts three months, and the patient stopps smoking after the first week. Zyban carries a significant risk of seizures: one in 1,000 people have fits or go into convulsions as result of taking it. 2 per cent of patients experience some heart palpitations. But it is not clear whether these adverse reactions result in death.

So far, 407 adverse reactions to Zyban have been reported, according to the Health Canada officials. As a result, patients taking the drug had experienced three deaths, seven non-fatal heart attacks, 64 convulsions or seizures, seven cases of hypoglycemia (low blood sugar), 163 allergic reactions, 52 psychiatric reactions (including one suicide attempt), and 16 reports of vision problems.

Canada's Health Therapeutic Products Program, which monitors drug safety, announced that it will "continues to work with the manufacturer to re-evaluate and update the safety profile of Zyban." Ms. Phillips, Glaxo's spokeswoman, said she wasn't surprised because "The more people that take any product, even.phpirin, the more side-effects or adverse events are going to be reported," and added that "When you have millions of people taking anything, even taking a glass of water, some are going to report different adverse events." "People who smoke are at greatly increased risk: they're about five times more likely than non-smokers to have a heart attack or heart problems," she concluded.

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