Australia Probing Deaths Linked To Anti-Smoking Pill
04/27/01
BRISBANE, Australia (AP)--Health authorities said Friday they were investigating four deaths in Australia linked to the anti-smoking pill Zyban.
The Therapeutic Goods Administration said the drug, which is made by British pharmaceutical giant GlaxoSmithKline PLC (GSK), has been linked to more than 600 adverse reactions since it came on the market in Australia in November. The TGA also said the product is on "safety watch."
"Four reports of suspected adverse reactions to Zyban SR with a fatal outcome have been received," the TGA said in a statement Friday.
"Further information about each case is being sought."
The TGA said it isn't yet possible to establish or exclude whether Zyban caused the deaths.
The TGA said its Adverse Drugs Reaction Committee has recorded 628 Australian reports of suspected reactions since the product was launched in Australia. In 593 cases, Zyban was implicated as the sole suspected drug, the authority said.
The most common reactions thought to be linked to Zyban are skin reactions, psychological disturbances, nervous system problems and stomach upsets, the TGA said.
The world's first anti-smoking pill, Zyban has been hailed as a breakthrough for would-be quitters. The pill contains no nicotine but acts on chemicals in the brain to help smokers give up the habit.
Zyban has also been suspected in some 35 deaths in Britain, but none have been linked directly to the medication.
GlaxoSmithKline spokeswoman Lisl Cropper said the company is aware of the TGA's reports and is working with authorities.
"It is the TGA's role to monitor all medicine and this is really part of their ongoing work," Cropper said.
"Our position is that we work with them and we take all reports of any adverse reaction seriously."