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Quit-smoking pill known to trigger depression up for subsidy |
Apr 24th 2008 5:22pm
NZPA Wgtn PHARMAC DECIDING ON SUBSIDY FOR PILL KNOWN TO TRIGGER DEPRESSION
HEALTH-SUPERPILLS 734 words
By Kent Atkinson of NZPA
Government drug funding agency Pharmac will next week decide whether a highly touted quit-smoking pill that feeds a "pleasure pathway" in smokers' brains should be subsidised.
Subsidy of the Pfizer Inc drug varenicline was planned to start on June 1, but it was put on hold after the drug was linked to dozens of suicides and suicidal behaviours in hundreds of patients overseas.
The drug, sold in the United States as Chantix since 2006, has been approved since April 2007 for unsubsidised sale in New Zealand, branded as Champix. It binds to the same spots in the brain that nicotine does when people smoke, causing the release of a "feel-good" chemical, dopamine.
Taking it is supposed to keep any inhaled nicotine from giving the same buzz.
But Pharmac funding and procurement manager Steffan Crausaz said earlier this year that a planned subsidy from June had been put on hold following safety concerns overseas.
In the United States, varenicline is the subject of a US FDA advisory linking it to serious neuropsychiatric symptoms. The agency has issued a warning the drug may worsen psychiatric illness that is under control or prompt a recurrence of an old psychiatric illness.
The users are being advised to inform healthcare providers about their prior psychiatric illness and should immediately inform their doctors about changes in mood or behaviour. The advisory also highlighted the manufacturer's recent label update to warn about the possibility of severe changes in mood and behaviour in those taking the drug.
Pharmac referred the latest data on potential safety concerns, back to its pharmacology and therapeutics advisory committee, which has since reported back and Pharmac executives have made a recommendation to next week's board meeting.
Last year Pfizer's New Zealand portfolio manager Don Budge said Champix was safe, and its main side effect was nausea, experienced by about 30 percent of users in clinical trials.
Other possible side effects included headaches, difficulty in sleeping, abnormal dreams, dizziness, weakness, constipation, indigestion, bloating, dry mouth, vomiting, increased appetite and changes in taste.
The Ministry of Health-funded based intensive medicines monitoring programme (IMMP) has had the drug on its list of drugs being monitored for side effects since last July. Director Mira Harrison-Woolrych said any Pharmac subsidy for varenicline would meant more people used it and the new users would include poorer patients, and potentially those at increased risk of serious adverse events to varenicline.
"Much about the side effect profile of this medicine in New Zealand patients remains unknown," Dr Harrison-Woolrych told the Pharmacy Today website. The IMMP has asked Pharmac for funding for intensive monitoring, especially as Pfizer has been advertising the drug direct to consumers, raising the pressure for doctors to prescribe it.
Hayden McRobbie, a research fellow at Auckland University's clinical trials research unit, told Pharmacy Today that the exact relationship between the drug use and depression or psychiatric illness had not been clearly established. People become depressed while trying to stop smoking, particularly during the first four weeks of nicotine replacement therapy, and this was more likely if they have had a history of depression -- possibly it was the effort of giving up smoking rather than the drug which was causing psychiatric episodes.
Mr McRobbie, also a consultant to Pfizer, said the FDA advice strengthened requirements for the drug to be prescribed in conjunction with behavioural support. "Quitting smoking can cause several other withdrawal symptoms too," he said.
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Credit:NZPA
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