Fed: Four deaths linked to Zyban

AAP General News (Australia)
04-27-2001
Fed: Four deaths linked to Zyban

By Rada Rouse, National Medical Correspondent

BRISBANE, April 27 AAP - Australian health authorities were investigating four deaths
linked to the anti-smoking pill Zyban, the Commonwealth health department said today.

A safety watch was placed on the drug following a spate of adverse reactions since
it came on the market last November.

"Four reports of suspected adverse reactions to Zyban SR with a fatal outcome have
been received," the Therapeutic Goods Administration (TGA) said today in a statement to
AAP.

"Further information about each case is being sought," the TGA said, adding that it
was not yet possible to establish or exclude that Zyban caused the deaths.

The TGA said a high proportion of patients taking Zyban were likely to be in age groups
where sudden cardiovascular death occurs, and smoking increases that risk.

Since November 20 last year, the TGA's Adverse Drugs Reaction Committee had recorded
628 Australian reports of suspected adverse reactions, and in 593 cases, Zyban was implicated
as the sole suspected drug.

The most commonly reported problems included skin reactions (241 reports), psychological
disturbances (231), nervous system problems (219) and gastrointestinal tract reactions
(144).

As the first anti-smoking pill, Zyban has been hailed as a breakthrough for would-be quitters.

Australian health authorities were swamped with prescription requests when it was listed
on the Pharmaceutical Benefits Scheme (PBS) in February.

The pill contains no nicotine but acts on chemicals in the brain to help smokers give
up the habit.

People prone to seizures have been warned not to use it.

A British court is currently hearing an inquest into the death of an airline stewardess
who died a fortnight after her doctor prescribed Zyban.

Evidence has been given that the woman, who worked for British Airways, was also taking
anti-malarial tablets, which can increase the risk of seizures.

Thirty-five people have died in Britain since the drug hit the market, but no deaths
have yet been proved to be a result of taking the medication.

In Australia there has been unprecedented demand for the drug since its cost fell from
around $255 to $22 for a two-month course when it was subsidised under the PBS.

Each prescription requires special authorisation by the Health Insurance Commission
to ensure that patients comply with a requirement to undergo counselling.

The TGA said all reports of serious reactions to drugs were reviewed by a medical doctor.

AAP rr/jhm/cd/sb

KEYWORD: ZYBAN

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